Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00620

2 Trial Registration Date

2018-09-03

iRegistration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Health Care and Promotion Scheme

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Suzanne Hoi Shan LO

ii Address

8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

852 3943 4485

iv Email

suzannelo@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Suzanne Hoi Shan Lo

ii Address

8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

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

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

13Research 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

15Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

A home visiting and phone coaching self-management programme (“COMBO-KEY”)

iii Dosage form of the intervention

Home visits and phone coaching

iv Dosage of the intervention

Four home visits and five phone coaching

v Duration of the intervention

Eight weeks

vi Frequency of the intervention

Once a week

16Comparative Treatments

i Description/ name of comparative treatments

Usual stroke rehabilitation care

ii Dosage form of the comparative treatments

Depends on the participants' clinical needs

iii Dosage of the comparative treatments

Depends on the participants' clinical needs

iv Duration of the comparative treatments

Depends on the participants' clinical needs

v Frequency of the comparative treatments

Depends on the participants' clinical needs

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Stroke survivors aged 18 years or above, community dwelling, have a modified Rankin Scale score 3 (moderate to severe disability), and a Montreal Cognitive Assessment (MoCA) score >20.

ii Exclusion Criteria

Severe dysphasia or mental illnesses.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Participants will be randomly allocated at 1:1 ratio according to a computer-generated random number

ii Nature of control

Placebo

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

It 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

Not Yet Recruiting

23Primary Outcome

iThe Name of the outcome

Self-efficacy

iiThe metric or method of measurement used

Stroke Self-Efficacy Questionnaire

iiiThe timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

24Secondary Outcome

iThe Name of the outcome

Outcome expectation

iiThe metric or method of measurement used

Stroke Self-management Outcome Expectation Scale

iiiThe timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

iThe Name of the outcome

Self-management behaviours

iiThe metric or method of measurement used

Stroke Self-management Behaviours Performance Scale

iiiThe timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

iThe Name of the outcome

Quality of Life

iiThe metric or method of measurement used

Stroke Specific Quality of Life Scale

iiiThe timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

iThe Name of the outcome

Depressive symptoms

iiThe metric or method of measurement used

Geriatric Depression Scale

iiiThe timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

iThe Name of the outcome

Community reintegration

iiThe metric or method of measurement used

Reintegration to Normal Living Index

iiiThe timepoint(s) of primary interest

Baseline and immediately after completion of the intervention

Secondary Outcome

iThe Name of the outcome

Usage of the programme

iiThe metric or method of measurement used

Satisfaction, frequency of usage, level of goal attainment

iiiThe timepoint(s) of primary interest

Immediately after completion of the intervention

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2022-11-30

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-09-03