Centre For Clinical Research And Biostatistics (CCRB)

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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

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

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

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

Please specify

iv IRB/IEC approval reference number

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

iv Dosage of the intervention

v Duration of the intervention

Once a week for 4 weeks

vi Frequency of the intervention

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

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

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

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-07-15

21 Target Sample Size

100

22 Recruitment Status

Recruiting

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

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-01-19