Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00620

2 Trial Registration Date

2018-09-03

i Registration Status

Prospective

3 Secondary IDs

01170718

4 Source(s) of Funding

Health Care and Promotion Scheme

5 Primary Sponsor

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

6 Secondary Sponsor

The Food and Health Bureau, The Government of the Hong Kong Special Administrative Region

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

LO Hoi Shan Suzanne

ii Address

Room 826, 8/F, Esther Lee Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR

iii Phone

3943 4485

iv Email

suzannelo@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong Special Administrative Region, People's Republic of China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

LO Hoi Shan Suzanne

ii Address

Room 826, 8/F, Esther Lee Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR

iii Phone

3943 4485

iv Email

suzannelo@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong Special Administrative Region, People's Republic of China

9 Official Scientific Title of the Study

“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

10 Public Title

“COMBO-KEY” (Coaching Ongoing Momentum Building On stroKe rEcovery journeY): A territory-wide project

i Public Title in Chinese 研究名稱

「甘寶–中風復康動力教與練家訪電話雙軌支援」：全港性研究計劃

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong Special Administrative Region, People's Republic of China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-03-19

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.009

14 Medical Condition Being Studied

Stroke

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

The intervention is a home visiting and phone coaching self-management programme (“COMBO-KEY”) which is underpinned by Bandura’s constructs of self-efficacy and outcome expectation. It will last for eight weeks with four home visits (about 1.5-2 hour each) and five phone coaching sessions. Strategies to enhance self-efficacy and outcome expectations will be adopted. Home visits will be delivered by a Coach Leader who is either a registered nurse or a social care provider. Phone coaching will be conducted by a Coach who is a trained lay volunteer with a Bachelor degree in health or social sciences. We will establish a team of 18 trained coaches. Both Coach Leaders and Coaches will receive prior training. The programme 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, 15 videos/audios on sharing of experience by survivors who managed their post-stroke challenges successfully (about 10 minutes each), 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.

iii Dosage form of the intervention

Home visits, phone coaching sessions, a workbook, a toolkit, videos/audios, a quick reference guide, a telephone hotline

iv Dosage of the intervention

Four home visits (about 1.5-2 hours each) and five phone coaching sessions

v Duration of the intervention

Eight weeks

vi Frequency of the intervention

Once a week

16 Comparative Treatments

i Description/ name of comparative treatments

The participants in the control 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.

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Eight weeks

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Stroke survivors: (1) 18 years old or above, (2) Community dwelling, (3) Have a modified Rankin Scale score equal to or greater than 3 (moderate to severe disability), (4) Have a Montreal Cognitive Assessment score >20.

ii Exclusion Criteria

Stroke survivors: (1) Have severe dysphasia, (2) Are diagnosed with a mental illness.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomly allocated in a 1:1 ratio to either an intervention group or a control group

ii Nature of control

Uncontrolled

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

This is not a drug trial.

vi Study Objectives (Optional)

20 Anticipated trial start date

2019-03-01

21 Target Sample Size

134

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

Self-efficacy in performing daily functional activities and self management

ii The metric or method of measurement used

The 13-item Chinese version of the Stroke Self-Efficacy Questionnaire

iii The timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

24 Secondary Outcome

i The Name of the outcome

Outcome expectation of stroke self-management behaviours

ii The metric or method of measurement used

The 11-item Chinese version of the Stroke Self-management Outcome Expectation Scale

iii The timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

i The Name of the outcome

Satisfaction with performance of stroke self-management behaviours

ii The metric or method of measurement used

The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale

iii The timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

i The Name of the outcome

Health-related quality of life

ii The metric or method of measurement used

The 49-item Chinese version of the Stroke Specific Quality of Life Scale

iii The timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

i The Name of the outcome

Depressive symptoms

ii The metric or method of measurement used

The 15-item Chinese version of the Geriatric Depression Scale

iii The timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

i The Name of the outcome

Community reintegration

ii The metric or method of measurement used

The 11-item Chinese version of the Reintegration to Normal Living Index

iii The timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

i The Name of the outcome

Satisfaction with the programme (Participants in the intervention group)

ii The metric or method of measurement used

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)

iii The timepoint(s) of primary interest

Immediately after completion of the intervention

Secondary Outcome

i The Name of the outcome

Usage of the resource package (Participants in the intervention group)

ii The metric or method of measurement used

Frequency (minutes) of using the resource package per week

iii The timepoint(s) of primary interest

Immediately after completion of the intervention

Secondary Outcome

i The Name of the outcome

Level of goal attainment (Participants in the intervention group)

ii The metric or method of measurement used

Rate the level of goal attainment on a scale from 0-Not attained, 1-Partially attained, to 2-Completely attained

iii The timepoint(s) of primary interest

Immediately after completion of the intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-11-30

27 Primary Registry and Trial Identifying Number

ChiCTR1800018358

28 Date of Registration in Primary Registry

2018-09-03

Back History

Trial Detail