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"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery

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ClinicalTrials.gov Identifier: NCT03741842
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Suzanne H. S. Lo, Chinese University of Hong Kong

Brief Summary:
Building confidence and capabilities to transfer rehabilitative knowledge and skills into lifestyle-workable strategies for changing health behaviours among stroke survivors are important to optimise health outcomes and reduce risks of recurrent stroke. The aim of this project is to promote stroke survivors' health by building confidence and positive expectations of recovery outcomes, and enabling their engagement in stroke self-management behaviours.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: COMBO-KEY Not Applicable

Detailed Description:
A randomised controlled trial will be conducted to determine the effectiveness of a programme "Coaching Ongoing Momentum Building On stroKe rEcovery journeY" ("COMBO-KEY"), a home visiting and phone coaching programme, on community-dwelling stroke survivors' self-efficacy, outcome expectation, and engagement in stroke self-management behaviours. An estimated sample of 134 stroke survivors will be recruited. COMBO-KEY will be underpinned by Bandura's constructs of self-efficacy and outcome expectation. It will be delivered by trained coaches. Outcomes will be measured at baseline and immediately after completion of the programme. Generalised estimating equations model will be used to assess the differential changes in outcome variables from pre-test to post-test between the intervention and control groups with adjustment for their baseline levels.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: "COMBO-KEY" (Coaching Ongoing Momentum Building On stroKe rEcovery journeY) - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery: A Territory-wide Project
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: COMBO-KEY group
The participants in the intervention group will receive a home visiting and phone coaching self-management programme (Coaching Ongoing Momentum Building On stroKe rEcovery journeY "COMBO-KEY") which is underpinned by Bandura's constructs of self-efficacy and outcome expectation.
Behavioral: COMBO-KEY
The intervention will last for eight weeks with four home visits and five phone coaching sessions. It will also consist of a 4-item resource package for stroke survivors (including a stroke self-management and self-discovery workbook, a health and life planning toolkit, and videos on sharing of experience by survivors who managed their post-stroke challenges successfully, and a stroke self-management quick reference guide). A telephone hotline for survivors and caregivers to seek information and support related to stroke self-management will also be established. A programme protocol will be developed to ensure the consistent delivery of the programme.

No Intervention: Usual care group
The participants in the usual care group will receive usual rehabilitation services offered, including services by a community rehabilitation network such as exercise training, physical rehabilitation, or activities organised by stroke support groups.



Primary Outcome Measures :
  1. Change in the level of self-efficacy in performing daily functional activities and self management [ Time Frame: Change from baseline level to immediately after completion of the intervention ]
    The 13-item Chinese version of the Stroke Self-Efficacy Questionnaire will be used. The items assess the stroke survivors' confidence in performing self-management behaviours over a 0-no confidence to 10-very confident points scale. All item scores are summed (total 0-130). Higher scores indicate higher self-efficacy.


Secondary Outcome Measures :
  1. Change in the level of outcome expectation of stroke self-management behaviours [ Time Frame: Change from baseline level to immediately after completion of the intervention ]
    The 11-item Chinese version of the Stroke Self-management Outcome Expectation Scale will be used. The items assess the stroke survivors' confidence in the occurrence of outcomes after performing the self-management behaviours. All item scores are summed (total 0-110; each item is rated over 0-Strongly disagree to 10-Strongly agree). Higher scores represent higher confidence towards positive outcome.

  2. Change in the level of satisfaction with performance of stroke self-management behaviours [ Time Frame: Change from baseline level to immediately after completion of the intervention ]
    The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale will be used. The items ask the stroke survivors' satisfaction with their performance of self-management behaviours. All item scores are summed (total 0-110; each item is rated over 0-Strongly disagree to 10-Strongly agree). Higher scores represent higher satisfaction.

  3. Change in the level of health-related quality of life [ Time Frame: Change from baseline level to immediately after completion of the intervention ]
    The 49-item Chinese version of the Stroke Specific Quality of Life Scale will be used. The items ask the stroke survivors' agreement to the health conditions and difficulties in performing the tasks described. All item scores are summed (total 49-245; 1-Strongly disagree/couldn't do it to 5-Strongly agree/no trouble). Higher scores represent higher health-related quality of life.

  4. Change in the level of depressive symptoms [ Time Frame: Change from baseline level to immediately after completion of the intervention ]
    The 15-item Chinese version of the Geriatric Depression Scale will be used. The stroke survivors will be asked for agreement to the items based on their condition (total 0-15; Yes-1 score or No-0 score). A score of 5-8 indicates mild depression; 9-11 moderate depression; and 12-15 severe depression.

  5. Change in the level of community reintegration [ Time Frame: Change from baseline level to immediately after completion of the intervention ]
    The 11-item Chinese version of the Reintegration to Normal Living Index will be used. The stroke survivors will be asked the extent to which the items described their situation (total 11-55; 1-A small extent to 5-A great extent). Higher scores represent better community reintegration.

  6. Satisfaction with the programme (Participants in the intervention group) [ Time Frame: Immediately after completion of the intervention ]
    Rate the ease of use and relevance of contents and resources, arrangement, and coaches' performance on a 5-Likert point (1-Very dissatisfied to 5-Very satisfied)

  7. Usage of the resource package (Participants in the intervention group) [ Time Frame: Immediately after completion of the intervention ]
    Frequency (minutes) of using the resource package per week

  8. Level of goal attainment (Participants in the intervention group) [ Time Frame: Immediately after completion of the intervention ]
    Rate the level of goal attainment on a scale from 0-Not attained, 1-Partially attained, to 2-Completely attained



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinically diagnosed with stroke
  • 18 years old or above
  • Community dwelling
  • Have a modified Rankin Scale score equal to or greater than 3 (moderate to severe disability)
  • Have a Montreal Cognitive Assessment score >20

Exclusion Criteria:

  • Have severe dysphasia
  • Are diagnosed with a mental illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741842


Contacts
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Contact: Suzanne Lo 852-3943-4485 suzannelo@cuhk.edu.hk
Contact: Janita Chau 852-3943-6226 janitachau@cuhk.edu.hk

Locations
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Hong Kong
Community settings Recruiting
Hong Kong, Hong Kong
Contact: Suzanne Lo, PhD       suzannelo@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Suzanne Lo Chinese University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Suzanne H. S. Lo, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03741842     History of Changes
Other Study ID Numbers: 01170718
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases