StrokeNCT03741842
"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery
A study testing COMBO-KEY in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- COMBO-KEY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have severe dysphasia
- Are diagnosed with a mental illness
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- COMBO-KEY
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMBO-KEYBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Change from baseline level to immediately after completion of the intervention
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.
Measured: Change from baseline level to immediately after completion of the intervention
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.
Measured: Change from baseline level to immediately after completion of the intervention
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.
Measured: Change from baseline level to immediately after completion of the intervention
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.
Measured: Change from baseline level to immediately after completion of the intervention
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)
Measured: Immediately after completion of the intervention
Usage of the resource package (Participants in the intervention group)
Frequency (minutes) of using the resource package per week
Measured: Immediately after completion of the intervention
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
Measured: Immediately after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Mar 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne HS Lo, Chinese University of Hong Kong
- Investigators
- Suzanne Lo, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741842
- Sponsor's protocol ID
- 01170718
- Status last verified
- Aug 2022
- First submitted
- 12 Nov 2018
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31048448
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03741842
- Acronym / sponsor ID
- 01170718
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMBO-KEY group | Experimental | Behavioral: COMBO-KEYThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Have severe dysphasia
- Are diagnosed with a mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMBO-KEYThe 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. | Behavioural | COMBO-KEY group |
Primary outcome
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.
8 secondary outcomes
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
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
Change in the level of health-related quality of life
Time frame: Change from baseline level to immediately after completion of the intervention
Change in the level of depressive symptoms
Time frame: Change from baseline level to immediately after completion of the intervention
Change in the level of community reintegration
Time frame: Change from baseline level to immediately after completion of the intervention
Satisfaction with the programme (Participants in the intervention group)
Time frame: Immediately after completion of the intervention
Usage of the resource package (Participants in the intervention group)
Time frame: Immediately after completion of the intervention
Level of goal attainment (Participants in the intervention group)
Time frame: Immediately after completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 31048448Lo 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Lo principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMBO-KEY in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.