StrokeRECOVERNCT02247921
Rehabilitation for Disabled Stroke Patients in Rural China
A study testing Rehabilitation in people with Stroke, run by The George Institute for Global Health, China at 1 site in China.
Trial summary
Stroke is the second leading cause of mortality and disability among adults worldwide. Rehabilitation is an effective treatment for stroke; however rehabilitation services are far from adequate in China, especially in rural areas where the health and economic burden of disability from stroke is very high. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years，and≤79 years);
- Recent (<1 month) first-ever acute ischemic/hemorrhagic/undifferentiated stroke patients;or recurrent patients with the result of Modified Rankin Scale (MRS) no more than 2 points.
- With a reasonable expectation of 6 month survival post-discharge (i.e. not palliative, no evidence of widespread cancer etc.);
- Residual disability (requiring physical assistance for core activities of daily living defined as a Barthel Index score of 80 or lower)
Who cannot join
- Unable to identify a suitable family-nominated caregiver for training and subsequent delivery of care
- Unable to provide informed consent from both the patient (or by proxy) and the caregiver
Trial locations and contacts
1 site in 1 country.
China1 site
The Georgeinstitute of Global Health at Peking University Health Science Center
Beijing, Beijing Municipality, 100088
About this study
Official title: A Randomized Controlled Trial on Rehabilitation Through Caregiver-delivered Nurse-organized Service Programs for Disabled Stroke Patients in Rural China
Stroke is the second leading cause of mortality and disability among adults worldwide. Rehabilitation is an effective treatment for stroke; however rehabilitation services are far from adequate in China, especially in rural areas where the health and economic burden of disability from stroke is very high.
The investigators propose to develop, implement, and evaluate an evidence-based caregiver-delivered stroke rehabilitation program designed to improve the physical functioning of disabled stroke patients in rural China.
Read the detailed description
This randomized controlled trial will be conducted in Zhangwu People's Hospital in Liaoning Province, Qingtongxia People's Hospital in Ningxia Hui Autonomous Region and Dianjiang People's Hospital in Chongqing City. Eligible and consenting stroke in patients with residual disability will be randomized into the intervention group or control group after they have passed the acute care stage and approved by their physicians to be recruited into the study. Standardized baseline assessments for all patients include Barthel Index (activities of daily living), modified Rankin Scale, and other demographic, disease history, lifestyle, and health information. Nurses in the county hospital will be trained by rehabilitation specialists and will in turn train the family caregivers of patients in the intervention group with the aid of an easy-to-understand picture-rich rehabilitation manual, specially designed for this study. The content of training is based on 10 domains in the Barthel Index, which can be classified into 3 groups: mobility, self-care, and toileting. Nurses will do the telephone based follow-up to patients at approximately 2, 4, and 8 weeks post-discharge to provide follow-up care and consultation. Follow-up evaluation of all patients will be conducted by researchers not involved in the intervention. Pre-discharge evaluation including Barthel Index, modified Rankin Scale and Functional Ambulation Category will be conducted face to face with patients, . 3 months and 6 months evaluation will be conducted via telephone based interview.3 months evaluation includes living condition, Barthel Index ,modified Rankin Scale, hospitalization condition and medicine usage. Based on 3 months evaluation, 6 months evaluation includes additional measures: Functional Ambulation Classification, EQ-5D, 9-item Patient Health Questionnaire, physical examination and caregiver burden. Primary outcome will be the Barthel Index score at 6-month after hospital discharge. The study will be conducted in 2 phases: 1) pilot study (Lasting for 2 months, 30 patients in Zhangwu People's Hospital and 30 patients in Qingtongxia People's hospital); and 2) main study (Lasting for 15 months, 100 patients in Zhangwu People's Hospital, 100 patients in Qingtongxia People's hospital and 60 patients in Dianjiang People's Hospital). Information from pilot study will be used for refinement of the intervention and study implementation. Patients in the pilot study will be followed until the end of the study, resulting in a total of 320 patients.
Primary Hypothesis: The innovative caregiver-delivered nurse-organized rehabilitation intervention, compared to usual care, will significantly improve physical functioning of disabled stroke patients in rural China, as measured by the Barthel Index (activities of daily living) at six months after hospital discharge.
- Conditions
- Stroke
- Being tested
- Rehabilitation
- Keywords
- caregiver delivered rehabilitation, nurse-organized service, disabled stroke patients
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Patients recruited into the intervention arm will have their family-nominated caregivers trained by a trained nurse and guided by a culturally appropriate and easy-to-understand rehabilitation manual to be given to caregivers at the last session, shortly before hospital discharge to reduce contamination. The training sessions will take at least 90 minutes per day for 2 or 3 days.The nurse will call the patients and caregivers at 2, 4, and 8 weeks after hospital discharge to monitor progress and offer guidance on rehabilitation.Duration of the standardized yet individualized intervention by nurses will be 8 weeks; however, trained caregivers are expected to deliver the rehabilitation services to patients as long as they are needed.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Experimental | nurse-led caregiver-delivered rehabilitation Receives: Other: Rehabilitation |
| Usual care | No intervention | The patients in the control arm will receive conventional care in terms of access to rehabilitation in hospital, timeliness of discharge and follow-up, without any explicit provision of caregiver training or accelerated discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index (activities of daily living) at 6 months
Measured: 6 months
Secondary outcomes (5)
Barthel Index at 3 months
Measured: 3 months
Functional Ambulation Classification (FAC) at 6 months
Measured: 6 months
EQ-5D quality of life at 6 months
Measured: 6 months
Patient Health Questionnaire - 9 items at 6 months
Measured: 6 months
Modified Rankin Scale at 3 and 6 months
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completion31 Dec 2016
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lijing Yan, Principal investigator, Duke Kunshan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247921
- Sponsor's protocol ID
- CMB13-161
- Acronym
- RECOVER
- Status last verified
- May 2018
- First submitted
- 13 Sep 2014
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhou B, Zhang J, Zhao Y, Li X, Anderson CS, Xie B, Wang N, Zhang Y, Tang X, Prvu Bettger J, Chen S, Gu W, Luo R, Zhao Q, Li X, Sun Z, Lindley RI, Lamb SE, Wu Y, Shi J, Yan LL. Caregiver-Delivered Stroke Rehabilitation in Rural China. Stroke. 2019 Jul;50(7):1825-1830. doi: 10.1161/STROKEAHA.118.021558. Epub 2019 Jun 10.
PubMed 31177978
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Rehabilitation Through Caregiver-delivered Nurse-organized Service Programs for Disabled Stroke Patients in Rural China
- ClinicalTrials.gov ID
- NCT02247921
- Acronym / sponsor ID
- RECOVER / CMB13-161
- Conditions
- Stroke
- Keywords
- caregiver delivered rehabilitation, nurse-organized service, disabled stroke patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- The George Institute for Global Health, ChinaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the second leading cause of mortality and disability among adults worldwide. Rehabilitation is an effective treatment for stroke; however rehabilitation services are far from adequate in China, especially in rural areas where the health and economic burden of disability from stroke is very high.
The investigators propose to develop, implement, and evaluate an evidence-based caregiver-delivered stroke rehabilitation program designed to improve the physical functioning of disabled stroke patients in rural China.
Detailed description
This randomized controlled trial will be conducted in Zhangwu People's Hospital in Liaoning Province, Qingtongxia People's Hospital in Ningxia Hui Autonomous Region and Dianjiang People's Hospital in Chongqing City. Eligible and consenting stroke in patients with residual disability will be randomized into the intervention group or control group after they have passed the acute care stage and approved by their physicians to be recruited into the study. Standardized baseline assessments for all patients include Barthel Index (activities of daily living), modified Rankin Scale, and other demographic, disease history, lifestyle, and health information. Nurses in the county hospital will be trained by rehabilitation specialists and will in turn train the family caregivers of patients in the intervention group with the aid of an easy-to-understand picture-rich rehabilitation manual, specially designed for this study. The content of training is based on 10 domains in the Barthel Index, which can be classified into 3 groups: mobility, self-care, and toileting. Nurses will do the telephone based follow-up to patients at approximately 2, 4, and 8 weeks post-discharge to provide follow-up care and consultation. Follow-up evaluation of all patients will be conducted by researchers not involved in the intervention. Pre-discharge evaluation including Barthel Index, modified Rankin Scale and Functional Ambulation Category will be conducted face to face with patients, . 3 months and 6 months evaluation will be conducted via telephone based interview.3 months evaluation includes living condition, Barthel Index ,modified Rankin Scale, hospitalization condition and medicine usage. Based on 3 months evaluation, 6 months evaluation includes additional measures: Functional Ambulation Classification, EQ-5D, 9-item Patient Health Questionnaire, physical examination and caregiver burden. Primary outcome will be the Barthel Index score at 6-month after hospital discharge. The study will be conducted in 2 phases: 1) pilot study (Lasting for 2 months, 30 patients in Zhangwu People's Hospital and 30 patients in Qingtongxia People's hospital); and 2) main study (Lasting for 15 months, 100 patients in Zhangwu People's Hospital, 100 patients in Qingtongxia People's hospital and 60 patients in Dianjiang People's Hospital). Information from pilot study will be used for refinement of the intervention and study implementation. Patients in the pilot study will be followed until the end of the study, resulting in a total of 320 patients.
Primary Hypothesis: The innovative caregiver-delivered nurse-organized rehabilitation intervention, compared to usual care, will significantly improve physical functioning of disabled stroke patients in rural China, as measured by the Barthel Index (activities of daily living) at six months after hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Experimental | Other: Rehabilitationnurse-led caregiver-delivered rehabilitation |
| Usual care | No intervention | –The patients in the control arm will receive conventional care in terms of access to rehabilitation in hospital, timeliness of discharge and follow-up, without any explicit provision of caregiver training or accelerated discharge. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years，and≤79 years);
- Recent (<1 month) first-ever acute ischemic/hemorrhagic/undifferentiated stroke patients;or recurrent patients with the result of Modified Rankin Scale (MRS) no more than 2 points.
- With a reasonable expectation of 6 month survival post-discharge (i.e. not palliative, no evidence of widespread cancer etc.);
- Residual disability (requiring physical assistance for core activities of daily living defined as a Barthel Index score of 80 or lower)
Key exclusion criteria (2 listed)
- Unable to identify a suitable family-nominated caregiver for training and subsequent delivery of care
- Unable to provide informed consent from both the patient (or by proxy) and the caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationPatients recruited into the intervention arm will have their family-nominated caregivers trained by a trained nurse and guided by a culturally appropriate and easy-to-understand rehabilitation manual to be given to caregivers at the last session, shortly before hospital discharge to reduce contamination. The training sessions will take at least 90 minutes per day for 2 or 3 days.The nurse will call the patients and caregivers at 2, 4, and 8 weeks after hospital discharge to monitor progress and offer guidance on rehabilitation.Duration of the standardized yet individualized intervention by nurses will be 8 weeks; however, trained caregivers are expected to deliver the rehabilitation services to patients as long as they are needed. | Other | Rehabilitation |
Primary outcome
Barthel Index (activities of daily living) at 6 months
Time frame: 6 months
5 secondary outcomes
Barthel Index at 3 months
Time frame: 3 months
Functional Ambulation Classification (FAC) at 6 months
Time frame: 6 months
EQ-5D quality of life at 6 months
Time frame: 6 months
Patient Health Questionnaire - 9 items at 6 months
Time frame: 6 months
Modified Rankin Scale at 3 and 6 months
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 31177978Zhou B, Zhang J, Zhao Y, Li X, Anderson CS, Xie B, Wang N, Zhang Y, Tang X, Prvu Bettger J, Chen S, Gu W, Luo R, Zhao Q, Li X, Sun Z, Lindley RI, Lamb SE, Wu Y, Shi J, Yan LL. Caregiver-Delivered Stroke Rehabilitation in Rural China. Stroke. 2019 Jul;50(7):1825-1830. doi: 10.1161/STROKEAHA.118.021558. Epub 2019 Jun 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lijing Yan principal investigator
Duke Kunshan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Stroke, run by The George Institute for Global Health, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (activities of daily living) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02247921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.