<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02247921</url>
  </required_header>
  <id_info>
    <org_study_id>CMB13-161</org_study_id>
    <nct_id>NCT02247921</nct_id>
  </id_info>
  <brief_title>Rehabilitation for Disabled Stroke Patients in Rural China</brief_title>
  <acronym>RECOVER</acronym>
  <official_title>A Randomized Controlled Trial on Rehabilitation Through Caregiver-delivered Nurse-organized Service Programs for Disabled Stroke Patients in Rural China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The George Institute for Global Health, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The George Institute for Global Health, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is the second leading cause of mortality and disability among adults worldwide.&#xD;
      Rehabilitation is an effective treatment for stroke; however rehabilitation services are far&#xD;
      from adequate in China, especially in rural areas where the health and economic burden of&#xD;
      disability from stroke is very high.&#xD;
&#xD;
      The investigators propose to develop, implement, and evaluate an evidence-based&#xD;
      caregiver-delivered stroke rehabilitation program designed to improve the physical&#xD;
      functioning of disabled stroke patients in rural China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled trial will be conducted in Zhangwu People's Hospital in Liaoning&#xD;
      Province, Qingtongxia People's Hospital in Ningxia Hui Autonomous Region and Dianjiang&#xD;
      People's Hospital in Chongqing City. Eligible and consenting stroke in patients with residual&#xD;
      disability will be randomized into the intervention group or control group after they have&#xD;
      passed the acute care stage and approved by their physicians to be recruited into the study.&#xD;
      Standardized baseline assessments for all patients include Barthel Index (activities of daily&#xD;
      living), modified Rankin Scale, and other demographic, disease history, lifestyle, and health&#xD;
      information. Nurses in the county hospital will be trained by rehabilitation specialists and&#xD;
      will in turn train the family caregivers of patients in the intervention group with the aid&#xD;
      of an easy-to-understand picture-rich rehabilitation manual, specially designed for this&#xD;
      study. The content of training is based on 10 domains in the Barthel Index, which can be&#xD;
      classified into 3 groups: mobility, self-care, and toileting. Nurses will do the telephone&#xD;
      based follow-up to patients at approximately 2, 4, and 8 weeks post-discharge to provide&#xD;
      follow-up care and consultation. Follow-up evaluation of all patients will be conducted by&#xD;
      researchers not involved in the intervention. Pre-discharge evaluation including Barthel&#xD;
      Index, modified Rankin Scale and Functional Ambulation Category will be conducted face to&#xD;
      face with patients, . 3 months and 6 months evaluation will be conducted via telephone based&#xD;
      interview.3 months evaluation includes living condition, Barthel Index ,modified Rankin&#xD;
      Scale, hospitalization condition and medicine usage. Based on 3 months evaluation, 6 months&#xD;
      evaluation includes additional measures: Functional Ambulation Classification, EQ-5D, 9-item&#xD;
      Patient Health Questionnaire, physical examination and caregiver burden. Primary outcome will&#xD;
      be the Barthel Index score at 6-month after hospital discharge. The study will be conducted&#xD;
      in 2 phases: 1) pilot study (Lasting for 2 months, 30 patients in Zhangwu People's Hospital&#xD;
      and 30 patients in Qingtongxia People's hospital); and 2) main study (Lasting for 15 months,&#xD;
      100 patients in Zhangwu People's Hospital, 100 patients in Qingtongxia People's hospital and&#xD;
      60 patients in Dianjiang People's Hospital). Information from pilot study will be used for&#xD;
      refinement of the intervention and study implementation. Patients in the pilot study will be&#xD;
      followed until the end of the study, resulting in a total of 320 patients.&#xD;
&#xD;
      Primary Hypothesis: The innovative caregiver-delivered nurse-organized rehabilitation&#xD;
      intervention, compared to usual care, will significantly improve physical functioning of&#xD;
      disabled stroke patients in rural China, as measured by the Barthel Index (activities of&#xD;
      daily living) at six months after hospital discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Barthel Index (activities of daily living) at 6 months</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barthel Index at 3 months</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Classification (FAC) at 6 months</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D quality of life at 6 months</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire - 9 items at 6 months</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale at 3 and 6 months</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Caregiver Burden Index at 6 months</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>hospitalization</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>medical costs</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">248</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nurse-led caregiver-delivered rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>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.</description>
    <arm_group_label>Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (≥18 years，and≤79 years);&#xD;
&#xD;
          -  Recent (&lt;1 month) first-ever acute ischemic/hemorrhagic/undifferentiated stroke&#xD;
             patients;or recurrent patients with the result of Modified Rankin Scale (MRS) no more&#xD;
             than 2 points.&#xD;
&#xD;
          -  With a reasonable expectation of 6 month survival post-discharge (i.e. not palliative,&#xD;
             no evidence of widespread cancer etc.);&#xD;
&#xD;
          -  Residual disability (requiring physical assistance for core activities of daily living&#xD;
             defined as a Barthel Index score of 80 or lower)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to identify a suitable family-nominated caregiver for training and subsequent&#xD;
             delivery of care&#xD;
&#xD;
          -  Unable to provide informed consent from both the patient (or by proxy) and the&#xD;
             caregiver&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lijing Yan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Kunshan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Georgeinstitute of Global Health at Peking University Health Science Center</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caregiver delivered rehabilitation</keyword>
  <keyword>nurse-organized service</keyword>
  <keyword>disabled stroke patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02247921
org study id: CMB13-161
nct id: NCT02247921
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Barthel Index (activities of daily living) at 6 months
time frame: 6 months
measure: Barthel Index at 3 months
time frame: 3 months
measure: Functional Ambulation Classification (FAC) at 6 months
time frame: 6 months
measure: EQ-5D quality of life at 6 months
time frame: 6 months
measure: Patient Health Questionnaire - 9 items at 6 months
time frame: 6 months
measure: Modified Rankin Scale at 3 and 6 months
time frame: 3 and 6 months
measure: Caregiver Burden Index at 6 months
time frame: 6 months
measure: hospitalization
time frame: 6 months
measure: medical costs
time frame: 6 months
arm group label: Rehabilitation
arm group type: Experimental
description: nurse-led caregiver-delivered rehabilitation
arm group label: Usual care
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Rehabilitation
description: 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.
arm group label: Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Lijing Yan
role: Principal Investigator
affiliation: Duke Kunshan University
facility: 
country: China
responsible party type: Sponsor
mesh term: Stroke