Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00607

2 Trial Registration Date

2018-05-02

i Registration Status

Prospective

3 Secondary IDs

15162991

4 Source(s) of Funding

Health and Medical Research Fund

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

CHAU Pak Chun Janita

ii Address

Room 825, 8/F, Esther Lee Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

iii Phone

3943 6226

iv Email

janitachau@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

CHAU Pak Chun Janita

ii Address

Room 825, 8/F, Esther Lee Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

iii Phone

3943 6226

iv Email

janitachau@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

The effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial

10 Public Title

The effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial

i Public Title in Chinese 研究名稱

為社區中風復康者及照顧者設立的多醫療專業虛擬中風護理診所的成效及成本效益：隨機對照試驗

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?

2018-01-27

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.660

14 Medical Condition Being Studied

Stroke

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

An online platform that embraces readily accessible and reliable information to promote stroke recovery and offer support to survivors and caregivers will be developed. Participants will receive the service offered offered by a virtual multidisciplinary stroke care clinic (VMSCC) including access to 30 videos demonstrating self-care strategies, communicate with the nurse through video calls, telephone calls, hotline, and blood pressure monitoring.

iii Dosage form of the intervention

Online videos platform, video calls, telephone calls, hotline, blood pressure monitoring

iv Dosage of the intervention

30-45 minutes for each video chat

v Duration of the intervention

6 months

vi Frequency of the intervention

Monthly

16 Comparative Treatments

i Description/ name of comparative treatments

The participants in the control group will receive the usual rehabilitation services offered, including hospital-based health education, information about local community-based rehabilitation services, and outpatient rehabilitation services at a day hospital.

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

6 months

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Survivors: (1) Age of 18 years or older

(2) a diagnosis of ischaemic or haemorrhagic stroke

(3) within 3 months of stroke from symptom onset

(4) a Montreal Cognitive Assessment score ≥ 10/ Mini-Mental State Examination score of ≥ 18

Caregivers: (1) spending the most time caring for the survivor

Both survivors & caregivers: (1) able to communicate in Chinese

(2) able to operate the device kit

ii Exclusion Criteria

Survivors: (1) severe dysphasia that hinders their participation in video calls

Caregivers: (1) severe psychiatric condition that might affect their ability to provide care

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

2018-06-29

21 Target Sample Size

388

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Self-efficacy in performing daily functional activities and self management (Survivors)

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, 3 months and 6 months of the study

Primary Outcome

i The Name of the outcome

Health related quality of life (Survivors)

ii The metric or method of measurement used

The Chinese (HK) version of the EQ5D-5L

iii The timepoint(s) of primary interest

Baseline, 3 months and 6 months of the study

Primary Outcome

i The Name of the outcome

Stroke self-management behaviours (Survivors)

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, 3 months and 6 months of the study

Primary Outcome

i The Name of the outcome

Health related quality of life (Caregivers)

ii The metric or method of measurement used

The Chinese (HK) version of the Medical Outcome Study Short-Form General Health Survey

iii The timepoint(s) of primary interest

Baseline, 3 months and 6 months of the study

Primary Outcome

i The Name of the outcome

Depression (Both survivors and caregivers)

ii The metric or method of measurement used

The Chinese version of the Geriatric Depression Scale

iii The timepoint(s) of primary interest

Baseline, 3 months and 6 months of the study

Primary Outcome

i The Name of the outcome

Social participation (Survivors)

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

Baseline, 3 months and 6 months of the study

24 Secondary Outcome

i The Name of the outcome

Health service utilisation (Survivors)

ii The metric or method of measurement used

The number of Emergency admissions and total length of readmission hospital stay during the 6-month evaluative period

iii The timepoint(s) of primary interest

6 months of the study

Secondary Outcome

i The Name of the outcome

Participants' satisfaction (Both survivors and caregivers)

ii The metric or method of measurement used

A self-developed User Satisfaction Questionnaire

iii The timepoint(s) of primary interest

6 months of the study

Secondary Outcome

i The Name of the outcome

Adherence (Both survivors and caregivers)

ii The metric or method of measurement used

Attendance counted for those who attended at least 80% of the video call sessions

iii The timepoint(s) of primary interest

6 months of the study

Secondary Outcome

i The Name of the outcome

Coping strategies and satisfaction in caring (Caregivers)

ii The metric or method of measurement used

The Chinese version of the Carer's Assessment of Managing Index and the Carer's Assessment of Satisfaction Index

iii The timepoint(s) of primary interest

Baseline, 3 months, 6 months of the study

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-07-19

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-05-02