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Trial History Detail on 2019-11-20

CUHK_CCRB00620

2018-09-03

Prospective

01170718

Health Care and Promotion Scheme

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

LO Hoi Shan Suzanne

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

3943 4485

suzannelo@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

LO Hoi Shan Suzanne

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

3943 4485

suzannelo@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

“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

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

「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

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

Yes

2018-03-19

Joint CUHK-NTEC Clinical Research Ethics Committee

2018.009

Stroke

Behavior

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.

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

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

Eight weeks

Once a week

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.

Not applicable

Not applicable

Eight weeks

Not applicable

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.

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

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.

2019-03-01

134

Recruiting

Self-efficacy in performing daily functional activities and self management

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

Baseline and immediately after completion of the intervention

Outcome expectation of stroke self-management behaviours

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

Baseline and immediately after completion of the intervention

Satisfaction with performance of stroke self-management behaviours

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

Baseline and immediately after completion of the intervention

Health-related quality of life

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

Baseline and immediately after completion of the intervention

Depressive symptoms

The 15-item Chinese version of the Geriatric Depression Scale

Baseline and immediately after completion of the intervention

Community reintegration

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

Baseline and 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)

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

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

Immediately after completion of the intervention

No

2022-11-30

ChiCTR1800018358

2018-09-03

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