"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
COMBO-KEY
Sponsored by

About this trial
This is an interventional health services research trial for Stroke
Eligibility 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
Sites / Locations
- Community settings
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
COMBO-KEY group
Usual care group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in the level of self-efficacy in performing daily functional activities and self management
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
Change in the level of outcome expectation of stroke self-management behaviours
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.
Change in the level of satisfaction with performance of stroke self-management behaviours
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.
Change in the level of health-related quality of life
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.
Change in the level of depressive symptoms
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.
Change in the level of community reintegration
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.
Satisfaction with the programme (Participants in the intervention group)
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)
Usage of the resource package (Participants in the intervention group)
Frequency (minutes) of using the resource package per week
Level of goal attainment (Participants in the intervention group)
Rate the level of goal attainment on a scale from 0-Not attained, 1-Partially attained, to 2-Completely attained
Full Information
NCT ID
NCT03741842
First Posted
November 12, 2018
Last Updated
August 25, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03741842
Brief Title
"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMBO-KEY group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COMBO-KEY
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the level of self-efficacy in performing daily functional activities and self management
Description
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.
Time Frame
Change from baseline level to immediately after completion of the intervention
Secondary Outcome Measure Information:
Title
Change in the level of outcome expectation of stroke self-management behaviours
Description
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.
Time Frame
Change from baseline level to immediately after completion of the intervention
Title
Change in the level of satisfaction with performance of stroke self-management behaviours
Description
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.
Time Frame
Change from baseline level to immediately after completion of the intervention
Title
Change in the level of health-related quality of life
Description
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.
Time Frame
Change from baseline level to immediately after completion of the intervention
Title
Change in the level of depressive symptoms
Description
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.
Time Frame
Change from baseline level to immediately after completion of the intervention
Title
Change in the level of community reintegration
Description
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.
Time Frame
Change from baseline level to immediately after completion of the intervention
Title
Satisfaction with the programme (Participants in the intervention group)
Description
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)
Time Frame
Immediately after completion of the intervention
Title
Usage of the resource package (Participants in the intervention group)
Description
Frequency (minutes) of using the resource package per week
Time Frame
Immediately after completion of the intervention
Title
Level of goal attainment (Participants in the intervention group)
Description
Rate the level of goal attainment on a scale from 0-Not attained, 1-Partially attained, to 2-Completely attained
Time Frame
Immediately after completion of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community settings
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31048448
Citation
Lo SHS, Chau JPC, Chang AM, Choi KC, Wong RYM, Kwan JCY. Coaching Ongoing Momentum Building On stroKe rEcovery journeY ('COMBO-KEY'): a randomised controlled trial protocol. BMJ Open. 2019 May 1;9(4):e027936. doi: 10.1136/bmjopen-2018-027936.
Results Reference
derived
Learn more about this trial
"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery
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