Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00505

2 Trial Registration Date

2016-04-06

i Registration Status

Prospective

3 Secondary IDs

CRE2015.516-T

KC/KE-15-0164/ER-2

4 Source(s) of Funding

HMRF

5 Primary Sponsor

HMRF

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Doris, Sau-fung Yu

ii Address

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

iii Phone

852-39434289

iv Email

dyu@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

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

i Name

Doris, Sau-fung Yu

ii Address

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

iii Phone

852-39434289

iv Email

dyu@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

Enhancing the self-care of Chinese patients with chronic heart failure: Does an empowerment-based educational model make a difference?

10 Public Title

Enhancing the self-care of Chinese patients with chronic heart failure

i Public Title in Chinese 研究名稱

研究慢性心臟衰竭健康教育計劃是否能有效改善長者自我照顧心臟衰竭的能力

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-11-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE2015.516-T

14 Medical Condition Being Studied

Chronic Heart Failure

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

The empowerment-based self-care programme

For participants in intervention group, a research nurse will first assess how they take care of their disease at home and their health status. Thereafter, they will attend five weekly face-to-face sessions in small groups of 4-5 patients in the cardiac clinic. A registered nurse will guide them to set goals to improve the self-care in five areas including monitoring of bodily condition, managing the symptoms, controlling diet and fluid intake, managing the medications, and maintaining an active lifestyle. The nurse will provide the relevant health education and support them to set up plans to achieve the goals. Then, the nurse will make telephone calls to them to support them to achieve the self-care goals and give them further health advice.

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

12 weeks

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

Dialectic education:

For participants in control group, a research nurse will first assess how they take care of their disease at home and their health status. Then, they will attend five weekly face-to-face sessions in small groups of 4-5 patients in the cardiac clinic. A registered nurse will provide them education on how to monitor bodily condition, manage the symptoms, control diet and fluid intake, manage the medications, and maintain an active lifestyle. Then, the nurse will give them telephone calls to remind them to perform the recommended self-care.

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

12 weeks

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Chinese people aged 55 or above

Live in the community and have telephone access at home

A confirmed medical diagnosis of CHF of at least 6 months standing, and with New York Heart Association Class II-IV symptoms

ii Exclusion Criteria

Having and impaired communication capacity or impaired cognitive function preventing participation in the programme (as indicated by and Abbreviated Test Score <=6)

iii Age Minimum

55

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Block randomization with a block size of 8, 10, or 12 will be used.

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-07-01

21 Target Sample Size

236

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Self-care maintenance and management

ii The metric or method of measurement used

Self-care heart failure index (SCFHI; Chinese version)

iii The timepoint(s) of primary interest

At baseline, upon completion of study intervention and 3 months thereafter.

24 Secondary Outcome

i The Name of the outcome

Self-care knowledge, self-care confidence, HRQoL

ii The metric or method of measurement used

i) Dutch Heart Failure Knowledge Scale (DHFKS; Chinese version); ii) Minnesota Living with Heart Failure Questionnaire (MLHFQ; Chinese version)

iii The timepoint(s) of primary interest

At baseline, upon completion of study intervention and 3 months thereafter.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-08-06

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-16008254

28 Date of Registration in Primary Registry

2016-04-06

Back History

Trial Detail