Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00415

2 Trial Registration Date

2014-06-05

i Registration Status

Prospective

3 Secondary IDs

2014.281-T

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

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

i Name

Lee Wai Man

ii Address

Room E1114, Jubilee College, 81 Chung Hau Street, Homantin, Kowloon, Hong Kong

iii Phone

3120 2642

iv Email

wmlee@ouhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Lee Wai Man

ii Address

Room E1114, Jubilee College, 81 Chung Hau Street, Homantin, Kowloon, Hong Kong

iii Phone

3120 2642

iv Email

wmlee@ouhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effect of motivational interviewing on modifying cardiovascular disease patients' lifestyle: a pilot randomized controlled trial

10 Public Title

The effect of motivational interviewing on modifying cardiovascular disease patients' lifestyle: a pilot randomized controlled trial

i Public Title in Chinese 研究名稱

動機性訪談對改變心血管疾病患者生活方式的影響：試驗性隨機對照研究

11 Short Title (Optional)

Nil

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?

2014-05-22

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.281-T

14 Medical Condition Being Studied

Cardiovascular disease

15 Intervention

i Types of intervention

Other

Please specify

motivational interviewing

ii Description/ name of Intervention/article

Other than the cardiovascular rehabilitation provided by the study center, the patients will also receive motivational interviewing. It is a patient-centered, yet directive counseling style that aims at assisting patients in making behavior change.

iii Dosage form of the intervention

interview

iv Dosage of the intervention

4 sessions

v Duration of the intervention

Once a week for 4 weeks

vi Frequency of the intervention

once a week for 4 weeks

16 Comparative Treatments

i Description/ name of comparative treatments

The control group will attend the cardiovascular rehabilitation program provided by the study center

ii Dosage form of the comparative treatments

exercise training and mini-seminar

iii Dosage of the comparative treatments

once or twice a week

iv Duration of the comparative treatments

about one hour per session

v Frequency of the comparative treatments

4 weeks

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients who are aged 18 or above, either gender, and who have been diagnosed with CHDs or who have undergone percutaneous coronary interventions in the past 6-8 weeks

ii Exclusion Criteria

Patients who have been diagnosed with psychiatric illness or have severe hearing difficulty will be excluded.

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

convenience sampling

ii Nature of control

Dose comparison

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-07-15

21 Target Sample Size

100

22 Recruitment Status

Complete

23 Primary Outcome

Change of lifestyle (activity level, smoking, consumption of vegetable & fruit) at completion of intervention and 3 months after completion of intervention

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-02-19

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004763

28 Date of Registration in Primary Registry

2014-06-07

Back History

Trial Detail