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

NCT03741842 | Completed

• 1 other identifier: 01170718
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline level to immediately after completion of the intervention

Secondary Outcomes (8)

• Change in the level of outcome expectation of stroke self-management behaviours

  Change from baseline level to immediately after completion of the intervention

• Change in the level of satisfaction with performance of stroke self-management behaviours

  Change from baseline level to immediately after completion of the intervention

• Change in the level of health-related quality of life

  Change from baseline level to immediately after completion of the intervention

• Change in the level of depressive symptoms

  Change from baseline level to immediately after completion of the intervention

• Change in the level of community reintegration

  Change from baseline level to immediately after completion of the intervention

Study Arms (2)

COMBO-KEY group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

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.

Interventions

COMBO-KEY BEHAVIORAL

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.

COMBO-KEY group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed with stroke
• 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

You may not qualify if:

• Have severe dysphasia
• Are diagnosed with a mental illness

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Community settings

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 31048448 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Suzanne Lo

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: March 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 15, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)