Clinical trial NCT03741842: "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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in the level of self-efficacy in performing daily functional activities and self management
timeFrame: Change from baseline level to immediately after completion of the intervention
Secondary outcomes:
measure: Change in the level of outcome expectation of stroke self-management behaviours
timeFrame: Change from baseline level to immediately after completion of the intervention
measure: Change in the level of satisfaction with performance of stroke self-management behaviours
timeFrame: Change from baseline level to immediately after completion of the intervention
measure: Change in the level of health-related quality of life
timeFrame: Change from baseline level to immediately after completion of the intervention
measure: Change in the level of depressive symptoms
timeFrame: Change from baseline level to immediately after completion of the intervention
measure: Change in the level of community reintegration
timeFrame: Change from baseline level to immediately after completion of the intervention
measure: Satisfaction with the programme (Participants in the intervention group)
timeFrame: Immediately after completion of the intervention
measure: Usage of the resource package (Participants in the intervention group)
timeFrame: Immediately after completion of the intervention
measure: Level of goal attainment (Participants in the intervention group)
timeFrame: Immediately after completion of the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Community settings
Study officials:
affiliation: Chinese University of Hong Kong
name: Suzanne Lo
role: PRINCIPAL_INVESTIGATOR
References:
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.