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Frances Kam Yuet Wong, Shao Ling Wang, Shamay S M Ng, Paul H Lee, Arkers Kwan Ching Wong, Haiyan Li, Wei Wang, Lijie Wu, Yi Zhang, Yangyang Shi, Effects of a transitional home-based care program for stroke survivors in Harbin, China: a randomized controlled trial, Age and Ageing, Volume 51, Issue 2, February 2022, afac027, https://doi.org/10.1093/ageing/afac027
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Abstract
China has the biggest stroke burden in the world. Continued measures have been taken to enhance post-stroke rehabilitation management in the last two decades. The weak link is with home-based rehabilitation, with more attention and resources devoted to inpatient rehabilitation.
to address the service gap, this study tested a home-based transitional care model for stroke survivors.
a randomized controlled trial was conducted from February 2019 to May 2020 in Harbin, China, involving 116 patients with ischemic stroke. The intervention group participants (n = 58, 50%) received a 12-week home-based care program with components of transitional care measures and the national guidelines for facilitating patients to perform home-based exercises with continued monitoring and gradual progression. Control group participants received standard care including medication advice, rehabilitation exercise and one nurse-initiated follow-up call. Data were collected at baseline and after a 90-day (post-intervention) and a 180-day (post-intervention) follow-up. The primary outcome was quality of life (QOL), measured using the EuroQol-Five Dimension 5-Level scale (EQ-5D-5L).
both intervention and control groups showed improvement in EQ-5D-5L from baseline to post-intervention (0.66 versus 0.83, P < 0.001) and (0.66 versus 0.77, P < 0.001), respectively, and there was significant group-by-time interaction in EuroQol-Visual Analogue Scale from baseline to post-intervention at 90 days and follow-up at 180 days with the intervention group experiencing better improvement. Similarly, significant interaction effects were also found in the Stroke Impact Symptom scale, self-efficacy and modified Barthel Index.
home-based transitional care was effective in improving QOL, symptoms, self-efficacy and activities of daily living.
Key Points
A structured, home-based transitional care program is effective in rehabilitation for stoke survivors after hospital discharge.
A duration of 12-week training, 5 days per week, 90 minutes per day, was found to be adequate to produce effects.
Positive outcomes were reported in terms of quality of life, post-stoke impact, self-efficacy and depressive symptoms.
A nurse case manager played a pivotal role in care delivery and coordination under the multidisciplinary approach.
Inexpensive and domestic items could be used as care toolkit to facilitate the rehabilitation training exercise in home setting.
Introduction
The global stroke burden remains high, and China has the biggest stroke burden in the world [1, 2]. There are 11.1 million survivors, 2.4 million new cases and 1.1 million deaths from stroke in China annually [3]. Those who survive live with negative sequelae, including disability and the chance of recurrent stroke [2]. The Chinese government has issued guidelines for secondary prevention of ischemic stroke, post-stroke management and rehabilitation [4, 5], but rehabilitation service is still regarded as suboptimal by both patients and providers [6]. In China, it was estimated that 30% to 60% of stroke survivors did not have access to rehabilitation services, and most of them were provided in inpatient settings [7]. For those who received post-hospital discharge rehabilitation, the extent of professional guidance was uncertain [7]. Early supported discharge programs employing continued comprehensive care can promote the rehabilitation of stroke survivors transiting from hospital back to the community [8], and reduce costs as compared with inpatient care [9].
Programs have been designed and delivered to post-discharge stroke survivors, aiming to improve quality of life (QOL) and functional and psychological outcomes [10–15]. However, the effects of these programs are inconclusive. A Cochrane review revealed that early supported discharge services resourced with coordinated multidisciplinary team (MDT) for acute stroke survivors could reduce hospital stay, improve outcome of death or dependency but no apparent hazards in terms of patient mood or QOL [10]. Huang et al.’s [11] meta-analysis, however, showed that home-based support could improve the depressive symptoms of stroke survivors but not physical function. A review of individual studies also produced mixed results. Wong and Yeung [12] and Chen, Sit and Shen [13] found significant improvements in QOL, activities of daily living (ADL) and re-hospitalisation in the intervention group, whereas Zhou et al. [14] and Saal et al. [15] detected no effects on similar outcomes using post-discharge home-based support.
Though there are inconclusive findings reported above, there is evidence suggesting that coordinated early discharge program with home visits had a better chance of reducing mortality and producing ADL benefits for stroke survivors [8, 10]. Whilst stroke rehabilitation is important to enhance QOL, a study reported that 40% of the stroke survivors were not properly assessed [2]. In light of the challenges facing post-stroke rehabilitation service in China and the lack of adequate evidence to guide best practice, there is a need to explore ways to enhance post-discharge support to reduce disease impact and improve the QOL of stroke survivors. The aim of this study is to determine the effects of 12-week home-based, therapist delivered coordinated stroke rehabilitation compared with usual care on QOL.
Methods
Design and participants
This was a randomized controlled trial conducted in an acute general hospital in Harbin, China. Participants were recruited from neurology units, using the following inclusion criteria: (i) aged ≥18, (ii) confirmed diagnosis of ischemic stroke based on magnetic resonance imaging and clinical judgement of stroke neurologists, (iii) National Institutes of Health Stroke Scale (NIHSS) [16] score ≥ 4 and < 16 (mild to moderately severe), (iv) Modified Rankin Scale (mRS) [17] score 2–4 (slight to moderately severe disability), (v) discharged home and (vi) premorbidly independent (mRS score ≤ 1). Patients who were cognitively impaired with a MoCA-Beijing [18] score ≤ 22, with neurological or other diseases affecting the limbs, discharged to a rehabilitation setting or dying, were excluded. A research coordinator approached eligible patients and introduced the project. Patients were reassured that their usual care would not be affected whether they participated in the study or not, and that the confidentiality and anonymity of their personal data would be strictly protected. Consenting patients signed a consent form. Ethical approval for this study was granted by Ethics Committees of the host university (HSEARS20180619003) and the study hospital (2018 Ethical Review #005). The trial was registered in ClinicalTrials.gov (NCT03884621).
Randomization
Block randomization was adopted, using 1:1 ratio block size. The computer-generated assignment was concealed in sequential opaque and sealed envelopes. After completing the baseline data collection, participants were allocated to the intervention or control group according to the concealed group assignment. The research assistants collecting the data were blinded to the group assignments.
Sample size calculation
The sample size was computed based on pilot data, using QOL as the primary outcome, measured by EuroQol-5 Dimensions (EQ-5D-5L) [19]. To achieve 80% power with a significance level of 0.05, with an effect size of 0.61 for EQ-5D-5L, a sample size of 88 was required. Assuming an attrition rate of 20%, this study required 110 participants (55 in each arm).
Intervention
Home-based rehabilitation for intervention group
The structured 4C, home-based post-discharge program (4C-HBP) was constructed based on the national stroke guidelines and transitional care framework. The Chinese [20], Canadian [21] and American [22] national guidelines were referenced, and they all advocated using a holistic approach to address patients’ needs in physical, psychological and social aspects with the engagement of family members in home-based rehabilitation. The principles of being goal-directed, being task-specific and progressing in exercise training were adopted [20–22]. A MDT was involved, including a physiotherapist, an occupational therapist, a speech therapist, a neurologist and a rehabilitation physician [20–22], with a designated case manager to oversee the implementation, which required regular review and monitoring [21, 22]. Continual follow-up was arranged in accordance with the transitional care framework, which included the key 4C elements of comprehensiveness, continuity, coordination and collaboration [12, 23]. Comprehensiveness was attained by the use of the Omaha System, which has a holistic approach [24] using an assessment–intervention–evaluation framework. The collaboration efforts were realized by having the MDT participate from the stage of protocol design to taking referrals from the nurse case manager (NCM) in the intervention phase. The NCM delivered and coordinated planned events during the 12-week program to ensure continuity of care.
Series of activities
The 4C-HBP lasted for 12 weeks, which was found to be adequate to produce effects [8]. There were a pre-discharge session, six post-discharge home visits (in odd-numbered weeks) and six telephone follow-up calls (in even-numbered weeks). A nurse-managed hotline was available throughout the 12 weeks.
Pre-discharge
Two days prior to discharge, the NCM would initiate a meeting with the patient and his/her family caregiver and provide routine post-discharge advice, including blood pressure monitoring, medication adherence and dietary and daily living care advice, as well as rehabilitation exercise. The nurse would prepare patients for the home-based follow-up, including goal-setting throughout the rehabilitation journey.
Post-discharge
The program protocol was structured and organized in accordance with the Omaha System (Table 1 and Supplementary Table 1). The Omaha System is a comprehensive assessment–intervention–evaluation framework that has been widely used in community care in the United States [24] and China [12, 23, 25, 26]. It has 42 problems categorized into four domains, namely environmental, psychosocial, physiological and health-related behaviors [24]. In the ‘assessment’ component, 24 stroke-specific problems that are commonly encountered by Chinese stroke survivors were identified [12, 26]. The trained NCM conducted the assessment according to the set protocol, which has specified assessment tools and a checklist of signs and symptoms furnished by the Omaha System.
Assessment and intervention of the 4C-HBP: Aim, content, persons involved and responsibilities
Aim and content . | Person(s) involved (responsibilities) . |
---|---|
Part A: Assessment | |
Aim: To determine the existence of stroke-specific problems based on the Omaha System* framework and specific assessment tools Content: Structured assessment protocols for the 24 stroke-specific problems with signs and symptoms and assessment tools enclosed | MDT (protocol setting) NCM (conducting assessment) |
Part B: Intervention scheme | |
(I) Teaching, guidance and counseling Aim: To provide information and materials for promoting patients’ responsibility for self-care and supporting problem solving for home-based care for patients and family members. Content: Knowledge-based topics:
| MDT (content review) NCM (delivering health education) |
(II) Treatment and procedures Aim: To deliver the functional training designed and prescribe exercises to achieve optimal rehabilitation outcomes Content: Intensity: At least 90 minutes per day, 5 days/week for 12 weeks Training and exercise protocol:
| MDT (exercise design) NCM (instruction and reinforcement) |
(III) Case management Aim: To coordinate and make referrals to other healthcare professionals as appropriate Content:
| NCM (intervention) MDT (expert advice to the NCM; accepting referrals as appropriate) |
(IV) Surveillance Aims: To measure and monitor the progress of rehabilitation and symptom management Content
| NCM |
Aim and content . | Person(s) involved (responsibilities) . |
---|---|
Part A: Assessment | |
Aim: To determine the existence of stroke-specific problems based on the Omaha System* framework and specific assessment tools Content: Structured assessment protocols for the 24 stroke-specific problems with signs and symptoms and assessment tools enclosed | MDT (protocol setting) NCM (conducting assessment) |
Part B: Intervention scheme | |
(I) Teaching, guidance and counseling Aim: To provide information and materials for promoting patients’ responsibility for self-care and supporting problem solving for home-based care for patients and family members. Content: Knowledge-based topics:
| MDT (content review) NCM (delivering health education) |
(II) Treatment and procedures Aim: To deliver the functional training designed and prescribe exercises to achieve optimal rehabilitation outcomes Content: Intensity: At least 90 minutes per day, 5 days/week for 12 weeks Training and exercise protocol:
| MDT (exercise design) NCM (instruction and reinforcement) |
(III) Case management Aim: To coordinate and make referrals to other healthcare professionals as appropriate Content:
| NCM (intervention) MDT (expert advice to the NCM; accepting referrals as appropriate) |
(IV) Surveillance Aims: To measure and monitor the progress of rehabilitation and symptom management Content
| NCM |
*A detailed description of the Omaha System can be found at http://omahasystem.org/ChineseAppendixA.html or http://www.omahasystem.org
Assessment and intervention of the 4C-HBP: Aim, content, persons involved and responsibilities
Aim and content . | Person(s) involved (responsibilities) . |
---|---|
Part A: Assessment | |
Aim: To determine the existence of stroke-specific problems based on the Omaha System* framework and specific assessment tools Content: Structured assessment protocols for the 24 stroke-specific problems with signs and symptoms and assessment tools enclosed | MDT (protocol setting) NCM (conducting assessment) |
Part B: Intervention scheme | |
(I) Teaching, guidance and counseling Aim: To provide information and materials for promoting patients’ responsibility for self-care and supporting problem solving for home-based care for patients and family members. Content: Knowledge-based topics:
| MDT (content review) NCM (delivering health education) |
(II) Treatment and procedures Aim: To deliver the functional training designed and prescribe exercises to achieve optimal rehabilitation outcomes Content: Intensity: At least 90 minutes per day, 5 days/week for 12 weeks Training and exercise protocol:
| MDT (exercise design) NCM (instruction and reinforcement) |
(III) Case management Aim: To coordinate and make referrals to other healthcare professionals as appropriate Content:
| NCM (intervention) MDT (expert advice to the NCM; accepting referrals as appropriate) |
(IV) Surveillance Aims: To measure and monitor the progress of rehabilitation and symptom management Content
| NCM |
Aim and content . | Person(s) involved (responsibilities) . |
---|---|
Part A: Assessment | |
Aim: To determine the existence of stroke-specific problems based on the Omaha System* framework and specific assessment tools Content: Structured assessment protocols for the 24 stroke-specific problems with signs and symptoms and assessment tools enclosed | MDT (protocol setting) NCM (conducting assessment) |
Part B: Intervention scheme | |
(I) Teaching, guidance and counseling Aim: To provide information and materials for promoting patients’ responsibility for self-care and supporting problem solving for home-based care for patients and family members. Content: Knowledge-based topics:
| MDT (content review) NCM (delivering health education) |
(II) Treatment and procedures Aim: To deliver the functional training designed and prescribe exercises to achieve optimal rehabilitation outcomes Content: Intensity: At least 90 minutes per day, 5 days/week for 12 weeks Training and exercise protocol:
| MDT (exercise design) NCM (instruction and reinforcement) |
(III) Case management Aim: To coordinate and make referrals to other healthcare professionals as appropriate Content:
| NCM (intervention) MDT (expert advice to the NCM; accepting referrals as appropriate) |
(IV) Surveillance Aims: To measure and monitor the progress of rehabilitation and symptom management Content
| NCM |
*A detailed description of the Omaha System can be found at http://omahasystem.org/ChineseAppendixA.html or http://www.omahasystem.org
There are four main schemes under ‘intervention’. The first intervention scheme was ‘teaching, guidance and counseling’, which aimed at providing information to promote self-care and support decision-making and problem-solving. The family members were present during the home visits, and they were involved in the process. The second intervention scheme was ‘treatment and procedures’, which aim was to deliver functional training designed to optimize rehabilitation outcomes. The MDT helped design the exercises and the NCM would deliver and reinforce the training during the home visits and telephone follow-up. The intensity of the training was 90 minutes per day, 5 days per week, for 12 weeks. The design of the rehabilitation exercise employed the principles of task-related training [27], which was derived from motor learning principles using goal-directed functional movement in daily life. It required patients to work in a task-specific activity to enhance muscle strength and motor performance. The number of repetitions, difficulty, speed and resistance increased as patients progressed. It is an effective strategy to improve the functional performance of stroke survivors in a home-based environment [28].
The third intervention scheme was ‘case management’. The NCM would make referrals to members of the MDT, according to the referral protocols co-developed by the interdisciplinary team, when patients were found to have unresolved problems and would benefit from expert consultation. The fourth intervention scheme was ‘surveillance’, when the NCM would set mutual goals with the patients and continue monitoring their progress and providing appropriate support.
Patient self-management toolkit
A stroke self-management home care toolkit, including a set of rehabilitation equipment and an information booklet, was provided to each patient. To make the tools applicable and affordable for practical use, the research team deliberately selected items that were inexpensive and could be easily purchased (e.g. towel, clothespins, cup sets, playdough, rolling pin, water bottle, elastic bands). The information booklet has written and pictorial instructions for stroke self-management, exercise and training, in alignment with the rehabilitation content and principles mentioned above. Patients were asked to keep logs on the training tasks, intensity, level of task difficulty and duration. They would also record their daily blood pressure and the presence of signs of discomfort, if any, during the home-based training. The NCM would review the records and revise the goals and action plans with the patients regularly.
Intervention team
The intervention team involved the MDT and a nurse assigned as case manager, who had the primary responsibility for conducting home visits and care coordination. The research team provided 2 weeks of theoretical and practical training to the MDT. The members of the MDT all had over 5 years of experience in stroke care and neurology medicine, so the training was mainly to align their practice with the intervention protocol and clarify the respective roles and responsibilities of the members. Since the intervention nurse had the specific role of stroke case manager, she was sponsored to attend a national post-basic stroke rehabilitation nursing course (72 hours), co-organized by a Guangdong hospital and a Hong Kong Foundation. The nurse passed a competence test and intervened satisfactorily in a practice case before the commencement of the study intervention.
Usual discharge care
Both groups received the usual discharge care for post-stroke patients, including advice on blood pressure monitoring, medication adherence, dietary and daily living care as well as rehabilitation exercise. Regular outpatient follow-up was arranged for the patients. Inpatient, general medical and emergency services provided by local hospitals or community health centers were available for use as appropriate. As routine practice, the discharged patients also received a nurse-initiated telephone call to follow up on their condition and reinforce the self-care and rehabilitation exercises.
Outcomes
Data were collected at baseline and at 90-day and 180-day post-intervention follow-ups. The primary outcome was EQ-5D-5L (Chinese). The instrument was validated among stroke survivors, with good criterion validity and predictive validity [29]. EQ-5D-5L measured the profile of mobility, self-care, usual activities, pain/discomfort and anxiety/depression with a single index value (range −0.111 to 1), and the EQ Visual Analogue Scale (EQVAS) denoted a patient’s overall health (range 0–100) [19, 29].

Consolidated Standards of Reporting Trials (CONSORT) flow diagram of the study.
There were a number of secondary outcome measures. The Stroke Impact Scale (SIS) was a stroke-specific 59-item instrument measuring the eight domains (range 0–100) of strength, memory and thinking, emotion, communication, ADL/instrumental ADL, mobility, hand function and social participation, together with an extra self-perceived stroke recovery item (range 0–100) [30]. The original English SIS version 3.0 was translated into Chinese by the research team following MAPI translation guidelines [31]. The eight domains in this translated version have moderate to high internal consistency, with Cronbach’s alphas ranging from 0.75 to 0.97. Other outcomes included ADL (Modified Barthel Index, MBI) [32] and self-efficacy (Self-Efficacy for Managing Chronic Disease 6-item Scale, SEMCD-6) [33]. Baseline demographic (such as age, gender, education level) and clinical data (such as stroke history, body mass index [BMI], blood pressure) were gathered. All the scales were internally consistent, with Cronbach’s alphas of 0.82–0.95.
Analysis
Statistical analysis was conducted using IBM SPSS Statistics 25. The intention-to-treat approach was adopted. Differences in baseline characteristics between the intervention and control groups were compared using the Chi-squared or Fisher’s exact tests for categorical variables and Student’s t-test for continuous variables. Generalized estimating equations (GEEs) were used to determine the group, time and interaction effects on the outcome variables. A P-value of <0.05 was considered statistically significant.
Results
A total of 2,612 acute stroke patients were screened with 2,383 (91%) not meeting the inclusion criteria with different reasons (Supplementary Table 2). Finally, 116 subjects meeting the selection criteria agreed to participate. They were randomized into intervention (58) or control (58) group. A total of five subjects were lost to follow up due to death (n = 2), refusal to participate (n = 1) and could not be contacted (n = 2) (Figure 1 for the CONSORT flow diagram). Table 2 depicts the demographic and clinical characteristics of the participants. The mean age of the patients was 66.6 (standard deviation [SD] 9.3). Our sample was dominant in males (69.8%), living with family (88.8%), with secondary education or above (90.5%), retired (82.8%) and covered by medical insurance (94.0%). Over half (58.6%) of the patients had a recurrent stroke. The mean NIHSS score was 5.2 (SD 1.5), with 82.8% having a slight/moderate level of disability. Nearly half (49.1%) had a BMI ≥ 25 kg/m2. The mean SBP was 145.5 mmHg (SD 17.7). There were no significant differences in the baseline data between the two groups (all Ps > 0.05).
. | All cases (n = 116) . | Intervention group (n = 58) . | Control group (n = 58) . | P-value . |
---|---|---|---|---|
Age, years, mean (SD) | 66.60 (9.34) | 66.21 (10.07) | 67.00 (8.61) | 0.649 |
Male | 81 (69.8) | 42 (72.4) | 39 (67.2) | 0.544 |
Married | 86 (74.1) | 40 (69.0) | 46 (79.3) | 0.203 |
Education level | 0.951 | |||
Primary and below | 11 (9.5) | 6 (10.3) | 5 (8.6) | |
Secondary | 97 (83.6) | 48 (82.8) | 49 (84.5) | |
Tertiary | 8 (6.9) | 4 (6.9) | 4 (6.9) | |
Living with family | 103 (88.8) | 51 (87.9) | 52 (89.7) | 0.769 |
Employment status | 0.571 | |||
Employed | 14 (12.1) | 6 (10.3) | 8 (13.8) | |
Unemployed | 6 (5.2) | 2 (3.4) | 4 (6.9) | |
Retired | 96 (82.8) | 50 (86.2) | 46 (79.3) | |
Source of medical payment | 0.153 | |||
Free | 1 (0.9) | 1 (1.7) | 0 (0.0) | |
Medical insurance | 109 (94.0) | 56 (96.6) | 53 (91.4) | |
Self | 6 (5.2) | 1 (1.7) | 5 (8.6) | |
First ever stroke | 48 (41.4) | 22 (37.9) | 26 (44.8) | 0.451 |
NIHSS score, mean (SD) | 5.21(1.52) | 5.38 (1.80) | 5.03 (1.17) | 0.223 |
Disability level | 0.832 | |||
mRS 2 | 21 (18.1) | 11 (19.0) | 10 (17.2) | |
mRS 3 | 75 (64.7) | 36 (62.1) | 39 (67.2) | |
mRS 4 | 20 (17.2) | 11 (19.0) | 9 (15.5) | |
Obesity (BMI ≥ 25 kg/m2) | 57 (49.1) | 30 (51.7) | 29 (50.0) | 0.853 |
SBP, mmHg, mean (SD) | 145.53 (17.66) | 145.64 (18.95) | 145.43 (16.43) | 0.950 |
DBP, mmHg, mean (SD) | 82.23 (11.70) | 82.90 (12.13) | 81.57 (11.32) | 0.543 |
. | All cases (n = 116) . | Intervention group (n = 58) . | Control group (n = 58) . | P-value . |
---|---|---|---|---|
Age, years, mean (SD) | 66.60 (9.34) | 66.21 (10.07) | 67.00 (8.61) | 0.649 |
Male | 81 (69.8) | 42 (72.4) | 39 (67.2) | 0.544 |
Married | 86 (74.1) | 40 (69.0) | 46 (79.3) | 0.203 |
Education level | 0.951 | |||
Primary and below | 11 (9.5) | 6 (10.3) | 5 (8.6) | |
Secondary | 97 (83.6) | 48 (82.8) | 49 (84.5) | |
Tertiary | 8 (6.9) | 4 (6.9) | 4 (6.9) | |
Living with family | 103 (88.8) | 51 (87.9) | 52 (89.7) | 0.769 |
Employment status | 0.571 | |||
Employed | 14 (12.1) | 6 (10.3) | 8 (13.8) | |
Unemployed | 6 (5.2) | 2 (3.4) | 4 (6.9) | |
Retired | 96 (82.8) | 50 (86.2) | 46 (79.3) | |
Source of medical payment | 0.153 | |||
Free | 1 (0.9) | 1 (1.7) | 0 (0.0) | |
Medical insurance | 109 (94.0) | 56 (96.6) | 53 (91.4) | |
Self | 6 (5.2) | 1 (1.7) | 5 (8.6) | |
First ever stroke | 48 (41.4) | 22 (37.9) | 26 (44.8) | 0.451 |
NIHSS score, mean (SD) | 5.21(1.52) | 5.38 (1.80) | 5.03 (1.17) | 0.223 |
Disability level | 0.832 | |||
mRS 2 | 21 (18.1) | 11 (19.0) | 10 (17.2) | |
mRS 3 | 75 (64.7) | 36 (62.1) | 39 (67.2) | |
mRS 4 | 20 (17.2) | 11 (19.0) | 9 (15.5) | |
Obesity (BMI ≥ 25 kg/m2) | 57 (49.1) | 30 (51.7) | 29 (50.0) | 0.853 |
SBP, mmHg, mean (SD) | 145.53 (17.66) | 145.64 (18.95) | 145.43 (16.43) | 0.950 |
DBP, mmHg, mean (SD) | 82.23 (11.70) | 82.90 (12.13) | 81.57 (11.32) | 0.543 |
Data are n (%) or mean (SD).
NIHSS, National Institute of Health Stroke Scale; SBP, systolic blood pressure; DSP, dystonic blood pressure.
. | All cases (n = 116) . | Intervention group (n = 58) . | Control group (n = 58) . | P-value . |
---|---|---|---|---|
Age, years, mean (SD) | 66.60 (9.34) | 66.21 (10.07) | 67.00 (8.61) | 0.649 |
Male | 81 (69.8) | 42 (72.4) | 39 (67.2) | 0.544 |
Married | 86 (74.1) | 40 (69.0) | 46 (79.3) | 0.203 |
Education level | 0.951 | |||
Primary and below | 11 (9.5) | 6 (10.3) | 5 (8.6) | |
Secondary | 97 (83.6) | 48 (82.8) | 49 (84.5) | |
Tertiary | 8 (6.9) | 4 (6.9) | 4 (6.9) | |
Living with family | 103 (88.8) | 51 (87.9) | 52 (89.7) | 0.769 |
Employment status | 0.571 | |||
Employed | 14 (12.1) | 6 (10.3) | 8 (13.8) | |
Unemployed | 6 (5.2) | 2 (3.4) | 4 (6.9) | |
Retired | 96 (82.8) | 50 (86.2) | 46 (79.3) | |
Source of medical payment | 0.153 | |||
Free | 1 (0.9) | 1 (1.7) | 0 (0.0) | |
Medical insurance | 109 (94.0) | 56 (96.6) | 53 (91.4) | |
Self | 6 (5.2) | 1 (1.7) | 5 (8.6) | |
First ever stroke | 48 (41.4) | 22 (37.9) | 26 (44.8) | 0.451 |
NIHSS score, mean (SD) | 5.21(1.52) | 5.38 (1.80) | 5.03 (1.17) | 0.223 |
Disability level | 0.832 | |||
mRS 2 | 21 (18.1) | 11 (19.0) | 10 (17.2) | |
mRS 3 | 75 (64.7) | 36 (62.1) | 39 (67.2) | |
mRS 4 | 20 (17.2) | 11 (19.0) | 9 (15.5) | |
Obesity (BMI ≥ 25 kg/m2) | 57 (49.1) | 30 (51.7) | 29 (50.0) | 0.853 |
SBP, mmHg, mean (SD) | 145.53 (17.66) | 145.64 (18.95) | 145.43 (16.43) | 0.950 |
DBP, mmHg, mean (SD) | 82.23 (11.70) | 82.90 (12.13) | 81.57 (11.32) | 0.543 |
. | All cases (n = 116) . | Intervention group (n = 58) . | Control group (n = 58) . | P-value . |
---|---|---|---|---|
Age, years, mean (SD) | 66.60 (9.34) | 66.21 (10.07) | 67.00 (8.61) | 0.649 |
Male | 81 (69.8) | 42 (72.4) | 39 (67.2) | 0.544 |
Married | 86 (74.1) | 40 (69.0) | 46 (79.3) | 0.203 |
Education level | 0.951 | |||
Primary and below | 11 (9.5) | 6 (10.3) | 5 (8.6) | |
Secondary | 97 (83.6) | 48 (82.8) | 49 (84.5) | |
Tertiary | 8 (6.9) | 4 (6.9) | 4 (6.9) | |
Living with family | 103 (88.8) | 51 (87.9) | 52 (89.7) | 0.769 |
Employment status | 0.571 | |||
Employed | 14 (12.1) | 6 (10.3) | 8 (13.8) | |
Unemployed | 6 (5.2) | 2 (3.4) | 4 (6.9) | |
Retired | 96 (82.8) | 50 (86.2) | 46 (79.3) | |
Source of medical payment | 0.153 | |||
Free | 1 (0.9) | 1 (1.7) | 0 (0.0) | |
Medical insurance | 109 (94.0) | 56 (96.6) | 53 (91.4) | |
Self | 6 (5.2) | 1 (1.7) | 5 (8.6) | |
First ever stroke | 48 (41.4) | 22 (37.9) | 26 (44.8) | 0.451 |
NIHSS score, mean (SD) | 5.21(1.52) | 5.38 (1.80) | 5.03 (1.17) | 0.223 |
Disability level | 0.832 | |||
mRS 2 | 21 (18.1) | 11 (19.0) | 10 (17.2) | |
mRS 3 | 75 (64.7) | 36 (62.1) | 39 (67.2) | |
mRS 4 | 20 (17.2) | 11 (19.0) | 9 (15.5) | |
Obesity (BMI ≥ 25 kg/m2) | 57 (49.1) | 30 (51.7) | 29 (50.0) | 0.853 |
SBP, mmHg, mean (SD) | 145.53 (17.66) | 145.64 (18.95) | 145.43 (16.43) | 0.950 |
DBP, mmHg, mean (SD) | 82.23 (11.70) | 82.90 (12.13) | 81.57 (11.32) | 0.543 |
Data are n (%) or mean (SD).
NIHSS, National Institute of Health Stroke Scale; SBP, systolic blood pressure; DSP, dystonic blood pressure.
Primary outcome
Table 3 shows that both intervention (0.66 versus 0.83, P < 0.001) and control groups (0.66 versus 0.77, P < 0.001) had improvement in EQ-5D-5L over time, and there was significant between-group difference at 90 days (P = 0.026). The group-by-time interaction was insignificant (P = 0.136). For EQVAS, the intervention group showed improvements at both 90 and 180 days (61.47 versus 76.48 versus 80.26; P = 0.015 to P < 0.001), but the control group did not, and the interaction effect was significant (P < 0.001).
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
EQ-5Q-5L Index | ||||||
Intervention (I) | 0.66 (0.01) | 0.83 (0.02) | 0.86 (0.02) | <0.001 | <0.001 | 0.001 |
Control (C) | 0.66 (0.02) | 0.77 (0.02) | 0.82 (0.02) | <0.001 | <0.001 | 0.001 |
P-value (I versus C) | 0.768 | 0.026 | 0.089 | P-value (interaction) | 0.136 | |
EQ-VAS | ||||||
Intervention (I) | 61.47 (2.09) | 76.48 (1.85) | 80.26 (1.49) | <0.001 | <0.001 | 0.015 |
Control (C) | 66.38 (1.94) | 73.37 (1.84) | 72.29 (2.27) | <0.001 | 0.015 | 0.482 |
P-value (I versus C) | 0.085 | 0.232 | 0.003 | P-value (interaction) | <0.001 | |
SIS strength | ||||||
Intervention (I) | 61.85 (2.58) | 87.34 (2.15) | 89.02 (1.93) | <0.001 | <0.001 | 0.028 |
Control (C) | 67.56 (2.35) | 80.20 (2.35) | 83.84 (2.53) | <0.001 | <0.001 | 0.003 |
P-value (I versus C) | 0.102 | 0.025 | 0.104 | P-value (interaction) | <0.001 | |
SIS memory and thinking | ||||||
Intervention (I) | 85.28 (2.23) | 92.83 (1.42) | 94.31 (1.36) | <0.001 | <0.001 | 0.040 |
Control (C) | 90.33 (1.27) | 91.60 (1.19) | 93.40 (1.28) | 0.344 | 0.036 | 0.111 |
P-value (I versus C) | 0.049 | 0.506 | 0.625 | P-value (interaction) | 0.027 | |
SIS emotion | ||||||
Intervention (I) | 87.40 (2.05) | 95.68 (1.37) | 95.14 (1.16) | <0.001 | <0.001 | 0.560 |
Control (C) | 91.19 (1.32) | 92.04 (1.52) | 94.66 (1.10) | 0.069 | 0.013 | 0.035 |
P-value (I versus C) | 0.121 | 0.075 | 0.762 | P-value (interaction) | 0.006 | |
SIS communication | ||||||
Intervention (I) | 93.47 (1.90) | 96.04 (1.27) | 95.71 (1.59) | 0.047 | 0.056 | 0.605 |
Control (C) | 99.45 (0.26) | 99.00 (0.38) | 98.15 (0.59) | 0.134 | 0.009 | 0.028 |
P-value (I versus C) | 0.002 | 0.025 | 0.151 | P-value (interaction) | 0.013 | |
SIS ADL | ||||||
Intervention (I) | 69.40 (2.45) | 86.29 (2.13) | 87.41 (2.27) | <0.001 | <0.001 | 0.111 |
Control (C) | 75.86 (2.17) | 84.75 (2.33) | 84.29 (2.47) | <0.001 | <0.001 | 0.699 |
P-value (I versus C) | 0.048 | 0.629 | 0.353 | P-value (interaction) | 0.002 | |
SIS Mobility | ||||||
Intervention (I) | 68.30 (2.65) | 87.54 (1.95) | 87.98 (2.01) | <0.001 | <0.001 | 0.654 |
Control (C) | 70.35 (2.73) | 82.39 (2.52) | 82.85 (2.84) | <0.001 | <0.001 | 0.648 |
P-value (I versus C) | 0.588 | 0.106 | 0.140 | P-value (interaction) | 0.029 | |
SIS hand functionality | ||||||
Intervention (I) | 60.95 (4.26) | 88.50 (3.49) | 90.82 (3.08) | <0.001 | <0.001 | 0.038 |
Control (C) | 77.07 (3.19) | 85.15 (3.32) | 86.45 (3.55) | <0.001 | 0.004 | 0.334 |
P-value (I versus C) | 0.002 | 0.487 | 0.353 | P-value (interaction) | <0.001 | |
SIS Participation | ||||||
Intervention (I) | 63.58 (2.18) | 83.46 (2.49) | 84.30 (2.16) | <0.001 | <0.001 | 0.579 |
Control (C) | 68.80 (2.47) | 77.84 (2.30) | 79.58 (2.46) | <0.001 | <0.001 | 0.239 |
P-value (I versus C) | 0.113 | 0.097 | 0.149 | P-value (interaction) | 0.007 | |
SIS stroke recovery | ||||||
Intervention (I) | 49.31 (3.24) | 76.16 (2.85) | 81.75 (2.66) | <0.001 | <0.001 | 0.005 |
Control (C) | 51.55 (3.74) | 60.96 (3.90) | 63.21 (4.33) | 0.011 | 0.002 | 0.364 |
P-value (I versus C) | 0.651 | 0.002 | <0.001 | P-value (interaction) | <0.001 |
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
EQ-5Q-5L Index | ||||||
Intervention (I) | 0.66 (0.01) | 0.83 (0.02) | 0.86 (0.02) | <0.001 | <0.001 | 0.001 |
Control (C) | 0.66 (0.02) | 0.77 (0.02) | 0.82 (0.02) | <0.001 | <0.001 | 0.001 |
P-value (I versus C) | 0.768 | 0.026 | 0.089 | P-value (interaction) | 0.136 | |
EQ-VAS | ||||||
Intervention (I) | 61.47 (2.09) | 76.48 (1.85) | 80.26 (1.49) | <0.001 | <0.001 | 0.015 |
Control (C) | 66.38 (1.94) | 73.37 (1.84) | 72.29 (2.27) | <0.001 | 0.015 | 0.482 |
P-value (I versus C) | 0.085 | 0.232 | 0.003 | P-value (interaction) | <0.001 | |
SIS strength | ||||||
Intervention (I) | 61.85 (2.58) | 87.34 (2.15) | 89.02 (1.93) | <0.001 | <0.001 | 0.028 |
Control (C) | 67.56 (2.35) | 80.20 (2.35) | 83.84 (2.53) | <0.001 | <0.001 | 0.003 |
P-value (I versus C) | 0.102 | 0.025 | 0.104 | P-value (interaction) | <0.001 | |
SIS memory and thinking | ||||||
Intervention (I) | 85.28 (2.23) | 92.83 (1.42) | 94.31 (1.36) | <0.001 | <0.001 | 0.040 |
Control (C) | 90.33 (1.27) | 91.60 (1.19) | 93.40 (1.28) | 0.344 | 0.036 | 0.111 |
P-value (I versus C) | 0.049 | 0.506 | 0.625 | P-value (interaction) | 0.027 | |
SIS emotion | ||||||
Intervention (I) | 87.40 (2.05) | 95.68 (1.37) | 95.14 (1.16) | <0.001 | <0.001 | 0.560 |
Control (C) | 91.19 (1.32) | 92.04 (1.52) | 94.66 (1.10) | 0.069 | 0.013 | 0.035 |
P-value (I versus C) | 0.121 | 0.075 | 0.762 | P-value (interaction) | 0.006 | |
SIS communication | ||||||
Intervention (I) | 93.47 (1.90) | 96.04 (1.27) | 95.71 (1.59) | 0.047 | 0.056 | 0.605 |
Control (C) | 99.45 (0.26) | 99.00 (0.38) | 98.15 (0.59) | 0.134 | 0.009 | 0.028 |
P-value (I versus C) | 0.002 | 0.025 | 0.151 | P-value (interaction) | 0.013 | |
SIS ADL | ||||||
Intervention (I) | 69.40 (2.45) | 86.29 (2.13) | 87.41 (2.27) | <0.001 | <0.001 | 0.111 |
Control (C) | 75.86 (2.17) | 84.75 (2.33) | 84.29 (2.47) | <0.001 | <0.001 | 0.699 |
P-value (I versus C) | 0.048 | 0.629 | 0.353 | P-value (interaction) | 0.002 | |
SIS Mobility | ||||||
Intervention (I) | 68.30 (2.65) | 87.54 (1.95) | 87.98 (2.01) | <0.001 | <0.001 | 0.654 |
Control (C) | 70.35 (2.73) | 82.39 (2.52) | 82.85 (2.84) | <0.001 | <0.001 | 0.648 |
P-value (I versus C) | 0.588 | 0.106 | 0.140 | P-value (interaction) | 0.029 | |
SIS hand functionality | ||||||
Intervention (I) | 60.95 (4.26) | 88.50 (3.49) | 90.82 (3.08) | <0.001 | <0.001 | 0.038 |
Control (C) | 77.07 (3.19) | 85.15 (3.32) | 86.45 (3.55) | <0.001 | 0.004 | 0.334 |
P-value (I versus C) | 0.002 | 0.487 | 0.353 | P-value (interaction) | <0.001 | |
SIS Participation | ||||||
Intervention (I) | 63.58 (2.18) | 83.46 (2.49) | 84.30 (2.16) | <0.001 | <0.001 | 0.579 |
Control (C) | 68.80 (2.47) | 77.84 (2.30) | 79.58 (2.46) | <0.001 | <0.001 | 0.239 |
P-value (I versus C) | 0.113 | 0.097 | 0.149 | P-value (interaction) | 0.007 | |
SIS stroke recovery | ||||||
Intervention (I) | 49.31 (3.24) | 76.16 (2.85) | 81.75 (2.66) | <0.001 | <0.001 | 0.005 |
Control (C) | 51.55 (3.74) | 60.96 (3.90) | 63.21 (4.33) | 0.011 | 0.002 | 0.364 |
P-value (I versus C) | 0.651 | 0.002 | <0.001 | P-value (interaction) | <0.001 |
SE, standard error.
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
EQ-5Q-5L Index | ||||||
Intervention (I) | 0.66 (0.01) | 0.83 (0.02) | 0.86 (0.02) | <0.001 | <0.001 | 0.001 |
Control (C) | 0.66 (0.02) | 0.77 (0.02) | 0.82 (0.02) | <0.001 | <0.001 | 0.001 |
P-value (I versus C) | 0.768 | 0.026 | 0.089 | P-value (interaction) | 0.136 | |
EQ-VAS | ||||||
Intervention (I) | 61.47 (2.09) | 76.48 (1.85) | 80.26 (1.49) | <0.001 | <0.001 | 0.015 |
Control (C) | 66.38 (1.94) | 73.37 (1.84) | 72.29 (2.27) | <0.001 | 0.015 | 0.482 |
P-value (I versus C) | 0.085 | 0.232 | 0.003 | P-value (interaction) | <0.001 | |
SIS strength | ||||||
Intervention (I) | 61.85 (2.58) | 87.34 (2.15) | 89.02 (1.93) | <0.001 | <0.001 | 0.028 |
Control (C) | 67.56 (2.35) | 80.20 (2.35) | 83.84 (2.53) | <0.001 | <0.001 | 0.003 |
P-value (I versus C) | 0.102 | 0.025 | 0.104 | P-value (interaction) | <0.001 | |
SIS memory and thinking | ||||||
Intervention (I) | 85.28 (2.23) | 92.83 (1.42) | 94.31 (1.36) | <0.001 | <0.001 | 0.040 |
Control (C) | 90.33 (1.27) | 91.60 (1.19) | 93.40 (1.28) | 0.344 | 0.036 | 0.111 |
P-value (I versus C) | 0.049 | 0.506 | 0.625 | P-value (interaction) | 0.027 | |
SIS emotion | ||||||
Intervention (I) | 87.40 (2.05) | 95.68 (1.37) | 95.14 (1.16) | <0.001 | <0.001 | 0.560 |
Control (C) | 91.19 (1.32) | 92.04 (1.52) | 94.66 (1.10) | 0.069 | 0.013 | 0.035 |
P-value (I versus C) | 0.121 | 0.075 | 0.762 | P-value (interaction) | 0.006 | |
SIS communication | ||||||
Intervention (I) | 93.47 (1.90) | 96.04 (1.27) | 95.71 (1.59) | 0.047 | 0.056 | 0.605 |
Control (C) | 99.45 (0.26) | 99.00 (0.38) | 98.15 (0.59) | 0.134 | 0.009 | 0.028 |
P-value (I versus C) | 0.002 | 0.025 | 0.151 | P-value (interaction) | 0.013 | |
SIS ADL | ||||||
Intervention (I) | 69.40 (2.45) | 86.29 (2.13) | 87.41 (2.27) | <0.001 | <0.001 | 0.111 |
Control (C) | 75.86 (2.17) | 84.75 (2.33) | 84.29 (2.47) | <0.001 | <0.001 | 0.699 |
P-value (I versus C) | 0.048 | 0.629 | 0.353 | P-value (interaction) | 0.002 | |
SIS Mobility | ||||||
Intervention (I) | 68.30 (2.65) | 87.54 (1.95) | 87.98 (2.01) | <0.001 | <0.001 | 0.654 |
Control (C) | 70.35 (2.73) | 82.39 (2.52) | 82.85 (2.84) | <0.001 | <0.001 | 0.648 |
P-value (I versus C) | 0.588 | 0.106 | 0.140 | P-value (interaction) | 0.029 | |
SIS hand functionality | ||||||
Intervention (I) | 60.95 (4.26) | 88.50 (3.49) | 90.82 (3.08) | <0.001 | <0.001 | 0.038 |
Control (C) | 77.07 (3.19) | 85.15 (3.32) | 86.45 (3.55) | <0.001 | 0.004 | 0.334 |
P-value (I versus C) | 0.002 | 0.487 | 0.353 | P-value (interaction) | <0.001 | |
SIS Participation | ||||||
Intervention (I) | 63.58 (2.18) | 83.46 (2.49) | 84.30 (2.16) | <0.001 | <0.001 | 0.579 |
Control (C) | 68.80 (2.47) | 77.84 (2.30) | 79.58 (2.46) | <0.001 | <0.001 | 0.239 |
P-value (I versus C) | 0.113 | 0.097 | 0.149 | P-value (interaction) | 0.007 | |
SIS stroke recovery | ||||||
Intervention (I) | 49.31 (3.24) | 76.16 (2.85) | 81.75 (2.66) | <0.001 | <0.001 | 0.005 |
Control (C) | 51.55 (3.74) | 60.96 (3.90) | 63.21 (4.33) | 0.011 | 0.002 | 0.364 |
P-value (I versus C) | 0.651 | 0.002 | <0.001 | P-value (interaction) | <0.001 |
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
EQ-5Q-5L Index | ||||||
Intervention (I) | 0.66 (0.01) | 0.83 (0.02) | 0.86 (0.02) | <0.001 | <0.001 | 0.001 |
Control (C) | 0.66 (0.02) | 0.77 (0.02) | 0.82 (0.02) | <0.001 | <0.001 | 0.001 |
P-value (I versus C) | 0.768 | 0.026 | 0.089 | P-value (interaction) | 0.136 | |
EQ-VAS | ||||||
Intervention (I) | 61.47 (2.09) | 76.48 (1.85) | 80.26 (1.49) | <0.001 | <0.001 | 0.015 |
Control (C) | 66.38 (1.94) | 73.37 (1.84) | 72.29 (2.27) | <0.001 | 0.015 | 0.482 |
P-value (I versus C) | 0.085 | 0.232 | 0.003 | P-value (interaction) | <0.001 | |
SIS strength | ||||||
Intervention (I) | 61.85 (2.58) | 87.34 (2.15) | 89.02 (1.93) | <0.001 | <0.001 | 0.028 |
Control (C) | 67.56 (2.35) | 80.20 (2.35) | 83.84 (2.53) | <0.001 | <0.001 | 0.003 |
P-value (I versus C) | 0.102 | 0.025 | 0.104 | P-value (interaction) | <0.001 | |
SIS memory and thinking | ||||||
Intervention (I) | 85.28 (2.23) | 92.83 (1.42) | 94.31 (1.36) | <0.001 | <0.001 | 0.040 |
Control (C) | 90.33 (1.27) | 91.60 (1.19) | 93.40 (1.28) | 0.344 | 0.036 | 0.111 |
P-value (I versus C) | 0.049 | 0.506 | 0.625 | P-value (interaction) | 0.027 | |
SIS emotion | ||||||
Intervention (I) | 87.40 (2.05) | 95.68 (1.37) | 95.14 (1.16) | <0.001 | <0.001 | 0.560 |
Control (C) | 91.19 (1.32) | 92.04 (1.52) | 94.66 (1.10) | 0.069 | 0.013 | 0.035 |
P-value (I versus C) | 0.121 | 0.075 | 0.762 | P-value (interaction) | 0.006 | |
SIS communication | ||||||
Intervention (I) | 93.47 (1.90) | 96.04 (1.27) | 95.71 (1.59) | 0.047 | 0.056 | 0.605 |
Control (C) | 99.45 (0.26) | 99.00 (0.38) | 98.15 (0.59) | 0.134 | 0.009 | 0.028 |
P-value (I versus C) | 0.002 | 0.025 | 0.151 | P-value (interaction) | 0.013 | |
SIS ADL | ||||||
Intervention (I) | 69.40 (2.45) | 86.29 (2.13) | 87.41 (2.27) | <0.001 | <0.001 | 0.111 |
Control (C) | 75.86 (2.17) | 84.75 (2.33) | 84.29 (2.47) | <0.001 | <0.001 | 0.699 |
P-value (I versus C) | 0.048 | 0.629 | 0.353 | P-value (interaction) | 0.002 | |
SIS Mobility | ||||||
Intervention (I) | 68.30 (2.65) | 87.54 (1.95) | 87.98 (2.01) | <0.001 | <0.001 | 0.654 |
Control (C) | 70.35 (2.73) | 82.39 (2.52) | 82.85 (2.84) | <0.001 | <0.001 | 0.648 |
P-value (I versus C) | 0.588 | 0.106 | 0.140 | P-value (interaction) | 0.029 | |
SIS hand functionality | ||||||
Intervention (I) | 60.95 (4.26) | 88.50 (3.49) | 90.82 (3.08) | <0.001 | <0.001 | 0.038 |
Control (C) | 77.07 (3.19) | 85.15 (3.32) | 86.45 (3.55) | <0.001 | 0.004 | 0.334 |
P-value (I versus C) | 0.002 | 0.487 | 0.353 | P-value (interaction) | <0.001 | |
SIS Participation | ||||||
Intervention (I) | 63.58 (2.18) | 83.46 (2.49) | 84.30 (2.16) | <0.001 | <0.001 | 0.579 |
Control (C) | 68.80 (2.47) | 77.84 (2.30) | 79.58 (2.46) | <0.001 | <0.001 | 0.239 |
P-value (I versus C) | 0.113 | 0.097 | 0.149 | P-value (interaction) | 0.007 | |
SIS stroke recovery | ||||||
Intervention (I) | 49.31 (3.24) | 76.16 (2.85) | 81.75 (2.66) | <0.001 | <0.001 | 0.005 |
Control (C) | 51.55 (3.74) | 60.96 (3.90) | 63.21 (4.33) | 0.011 | 0.002 | 0.364 |
P-value (I versus C) | 0.651 | 0.002 | <0.001 | P-value (interaction) | <0.001 |
SE, standard error.
Secondary outcomes
Among the eight SIS subscales (Table 3), the intervention group had significant improvements (P < 0.001) at both 90 and 180 days in seven subscales (strength, memory and thinking, emotion, ADL, mobility, hand functionality and participation) and borderline significance (P = 0.047, 90 days; P = 0.056, 180 days) in the communication subscale when compared with the baseline measure. Although the intervention group experienced non-significant (P > 0.05) improvement between 90 and 180 days in some subscales, significant interaction effects were achieved in all subscales and the global stroke recovery item. Interaction effects were also detected in SEMCD-6 and the MBI (Table 4).
Discussion
This study proved that a 12-week structured, home-based transitional care program (4C-HBP) was effective in producing positive outcomes for stroke survivors who fulfilled the inclusion criteria. This study has contributed to the service and knowledge gap of stroke rehabilitation particularly for the low and middle income countries (LMIC) such as China where unmet need for rehabilitation is high [34].
The common barriers to stroke rehabilitation in LMIC are access, resources, insufficient skilled workforce, standards and training packages with assistive devices appropriate for resource-poor countries [34]. This study found that a 12-week structured program with clear rehabilitation pathway and guidelines could bring about positive outcomes. Congruent with other programs, this study adopted a multidisciplinary approach [8, 35], and a coordinated MDT was key to reduce long-term dependency [10]. This study employed a designated NCM to work with the patients and caregivers. The NCM was pivotal in delivering and coordinating care, guided by set protocols that were constructed together with the MDT based on national stroke guidelines [20–22] and the Omaha System [24, 25].
In the current study, we contextualized the training in the home environment by using inexpensive and domestic items [35] and engaged patients and family members to empower them with self-management and problem-solving skills [36, 37]. In countries with limited resources, stroke rehabilitation solutions that are affordable and accessible are conducive to effective stroke rehabilitation [9].
This study recruited subjects with mild to moderate disability, and among the 70% of the potential subjects who did not fulfil the NIHSS criteria 90% of them had a NIHSS < 4. With limited healthcare resources, the treatment needs to be targeted. The Cochrane review reported that the early discharged support programs included in the analysis tend to recruit stroke survivors with moderate disability and those with mild to moderate disability at baseline showed greater reductions in dependency than those with more severe stroke with intervention [10]. This study sample, with a mean age of 66, is representative of the Chinese stroke population [3]. It is recommended that early intervention is crucial to maximize extent of recovery and reduce disease burden of these stroke survivors [10].
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
SEMCD-6 | ||||||
Intervention (I) | 6.59 (0.30) | 7.75 (0.22) | 7.93 (0.22) | <0.001 | <0.001 | 0.222 |
Control (C) | 6.91 (0.25) | 7.01 (0.27) | 7.19 (0.26) | 0.732 | 0.278 | 0.347 |
P-value (I versus C) | 0.410 | 0.033 | 0.029 | P-value (interaction) | 0.020 | |
MBI | ||||||
Intervention (I) | 83.86 (2.03) | 96.69 (0.69) | 96.79 (0.79) | <0.001 | <0.001 | 0.466 |
Control (C) | 87.93 (1.76) | 94.49 (1.27) | 93.06 (2.02) | <0.001 | <0.001 | 0.187 |
P-value (I versus C) | 0.130 | 0.128 | 0.071 | P-value (interaction) | 0.001 |
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
SEMCD-6 | ||||||
Intervention (I) | 6.59 (0.30) | 7.75 (0.22) | 7.93 (0.22) | <0.001 | <0.001 | 0.222 |
Control (C) | 6.91 (0.25) | 7.01 (0.27) | 7.19 (0.26) | 0.732 | 0.278 | 0.347 |
P-value (I versus C) | 0.410 | 0.033 | 0.029 | P-value (interaction) | 0.020 | |
MBI | ||||||
Intervention (I) | 83.86 (2.03) | 96.69 (0.69) | 96.79 (0.79) | <0.001 | <0.001 | 0.466 |
Control (C) | 87.93 (1.76) | 94.49 (1.27) | 93.06 (2.02) | <0.001 | <0.001 | 0.187 |
P-value (I versus C) | 0.130 | 0.128 | 0.071 | P-value (interaction) | 0.001 |
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
SEMCD-6 | ||||||
Intervention (I) | 6.59 (0.30) | 7.75 (0.22) | 7.93 (0.22) | <0.001 | <0.001 | 0.222 |
Control (C) | 6.91 (0.25) | 7.01 (0.27) | 7.19 (0.26) | 0.732 | 0.278 | 0.347 |
P-value (I versus C) | 0.410 | 0.033 | 0.029 | P-value (interaction) | 0.020 | |
MBI | ||||||
Intervention (I) | 83.86 (2.03) | 96.69 (0.69) | 96.79 (0.79) | <0.001 | <0.001 | 0.466 |
Control (C) | 87.93 (1.76) | 94.49 (1.27) | 93.06 (2.02) | <0.001 | <0.001 | 0.187 |
P-value (I versus C) | 0.130 | 0.128 | 0.071 | P-value (interaction) | 0.001 |
. | Baseline (B) . | Post-intervention (P) . | Follow-up (F) . | P-value (B versus P) . | P-value (B versus F) . | P-value (P versus F) . |
---|---|---|---|---|---|---|
SEMCD-6 | ||||||
Intervention (I) | 6.59 (0.30) | 7.75 (0.22) | 7.93 (0.22) | <0.001 | <0.001 | 0.222 |
Control (C) | 6.91 (0.25) | 7.01 (0.27) | 7.19 (0.26) | 0.732 | 0.278 | 0.347 |
P-value (I versus C) | 0.410 | 0.033 | 0.029 | P-value (interaction) | 0.020 | |
MBI | ||||||
Intervention (I) | 83.86 (2.03) | 96.69 (0.69) | 96.79 (0.79) | <0.001 | <0.001 | 0.466 |
Control (C) | 87.93 (1.76) | 94.49 (1.27) | 93.06 (2.02) | <0.001 | <0.001 | 0.187 |
P-value (I versus C) | 0.130 | 0.128 | 0.071 | P-value (interaction) | 0.001 |
Study limitations
This study had several limitations. First, it was a single-centered study; so it is difficult to generalize the results to other settings. Second, this study reported only the program effectiveness. The inclusion of a process evaluation will help shed light on the possible barriers in the implementation and how the delivered intervention brought about change. Third, this study has a high percentage of recurrent stroke (58.6%) and may encounter the challenges of a heterogeneous group. The team, however, conducted a GEE subgroup analysis and found the results of the two groups similar.
Conclusion
The GBD 2016 Lifetime Risk of Stroke Collaborators [1] reveals that China has the highest estimated risk of stroke in the world. The Ministry of Health has endorsed rehabilitation assessment as part of a national standard for acute stroke care, but many patients suffering from acute ischemic stroke are not properly assessed. This is due to limited medical resources as well as wide variation in practice, resulting in a non-standardized assessment and care process for stroke rehabilitation [2]. The investigators believe that this study has provided an evidence-based framework with structured and detailed content that could be implemented, replicated and further tested in other settings, particularly in the LMIC countries where rehabilitation needs are high and resources are scarce.
Acknowledgement
This study is dedicated to the late Madam Sheila Iu, Chair of the Hong Kong Nurses Training and Education Foundation. The authors are indebted to the multidisciplinary clinical team for making this study possible. The team included Zhang Yan, Pei Haixia, Ren Zhongjiao, Shan Qirui, Kong Ran, Hao Yupeng, Sun Jie and Yan Ying.
Declaration of Conflicts of Interest
None.
Declaration of Sources of Funding
T. S. Lo Foundation [5.53.56.ZH2Q, 2018]. The funder had no involvement in the study design, conduct or reporting.
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