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Trial History Detail on 2018-05-02

CUHK_CCRB00607

2018-05-02

Prospective

15162991

Health and Medical Research Fund

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

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

Not Applicable

CHAU Pak Chun Janita

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

3943 6226

janitachau@cuhk.edu.hk

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

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

CHAU Pak Chun Janita

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

3943 6226

janitachau@cuhk.edu.hk

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

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

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

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

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

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

Yes

2018-01-27

Joint CUHK-NTEC Clinical Research Ethics Committee

2017.660

Stroke

Behavior

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.

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

30-45 minutes for each video chat

6 months

Monthly

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.

Not applicable

Not applicable

6 months

Not applicable

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

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

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

18

999

Both Male and Female

Interventional

Randomized

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

Uncontrolled

Single-blind

Investigator/research team

Parallel

Other

This is not a drug trial.

2018-06-29

388

Not Yet Recruiting

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

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

Baseline, 3 months and 6 months of the study

Health related quality of life (Survivors)

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

Baseline, 3 months and 6 months of the study

Stroke self-management behaviours (Survivors)

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

Baseline, 3 months and 6 months of the study

Health related quality of life (Caregivers)

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

Baseline, 3 months and 6 months of the study

Depression (Both survivors and caregivers)

The Chinese version of the Geriatric Depression Scale

Baseline, 3 months and 6 months of the study

Social participation (Survivors)

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

Baseline, 3 months and 6 months of the study

Health service utilisation (Survivors)

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

6 months of the study

Participants' satisfaction (Both survivors and caregivers)

A self-developed User Satisfaction Questionnaire

6 months of the study

Adherence (Both survivors and caregivers)

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

6 months of the study

Coping strategies and satisfaction in caring (Caregivers)

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

Baseline, 3 months, 6 months of the study

No

2019-07-19

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