Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00614

2 Trial Registration Date

2018-07-09

i Registration Status

Prospective

3 Secondary IDs

NTWC/CREC/18038

4 Source(s) of Funding

Hong Kong College of Family Physician

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Man Kin Wong

ii Address

Madam Yung Fung Shee Health Center, 26 Sai Ching Street, Yuen Long

iii Phone

24685111

iv Email

wmk902@ha.org.hk

v Affiliation

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

vi Country

Hong Kong

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

i Name

Man Kin Wong

ii Address

Madam Yung Fung Shee Health Center, 26 Sai Ching Street, Yuen Long

iii Phone

24685111

iv Email

wmk902@ha.org.hk

v Affiliation

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

vi Country

Hong Kong

9 Official Scientific Title of the Study

Impact of Motivational Interviewing on the management of diabetic patients in the community: a pilot randomized controlled trial

10 Public Title

Impact of Motivational Interviewing on the management of diabetic patients in the community: a pilot randomized controlled trial

i Public Title in Chinese 研究名稱

動機式訪談法對社區糖尿病人影響之先導性隨機控制試驗

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-07-03

iii Full Name of IRB/IEC

New Territories West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

NTWC/CREC/18038

14 Medical Condition Being Studied

Diabetes

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

The theoretical approach of the intervention is based on self-efficacy theory and MI spirit. Perceived self-efficacy is defined as people’s beliefs about their capabilities of producing designated levels of performance exercising influence over events that affect their lives. MI is used as a method to facilitate this process. MI is a directive counselling style for eliciting behaviour change by helping patients to explore and resolve ambivalence. In addition to usual care, patients in the intervention group received a 1 year MI programme consisting of up to five individual counselling sessions lasting approximately 30-45 min. Each participant in the intervention group will be assigned an advanced practice nurse (APN) who has received trained in MI. The style of the interview is standardized with the following components: (1) seeking to understand the person’s frame of reference; (2) expressing acceptance and affirmation; (3) eliciting and selectively reinforcing the client’s own self-motivational statements of problem recognition, concern, desire and intention to change, and ability to change; (4) exploring the client’s degree of readiness to change; and (5) affirming the client’s freedom of choice and self-direction. The role of exploring readiness to change is that this is used as a component of the therapeutic process and not an outcome. Each session followed a semi-structured interview format of MI, especially developed for this intervention programme. Participants may bring up any issues of their concern related to diabetes self-care during the intervention sessions. The participants in the intervention group may be referred by the healthcare professional to individual counselling in lifestyle modification As deemed necessary by the personnel, and these include dietary changes, promotion of physical activity, as well as counseling on smoking and alcohol habits.

iii Dosage form of the intervention

Motivational interviewing

iv Dosage of the intervention

based on MI spirits, avoid righting reflex and advice

v Duration of the intervention

lasting approximately 30-45 min each session, for 1 year

vi Frequency of the intervention

at most every 16 weeks, up to five individual counselling sessions in 1 yr

16 Comparative Treatments

i Description/ name of comparative treatments

Medical treatment is not part of the intervention. All participants, irrespective of participation in the intervention group or the control group, will undergo the same routine check-up at GOPD in charge of their diabetes care. Biochemical tests and examinations will be performed during the visits in accordance with protocols.
Individual counselling and recommendations based on the results of the examinations, biochemical tests and their self-monitoring of blood glucose will be given. Renewal of prescribed medication will be done at these check-up visits. Patients could be referred for individual counselling including diet modification, optimization of physical activity, smoking cessation if applicable, and minimization of alcohol use if required by their usual healthcare provider.

ii Dosage form of the comparative treatments

usual care

iii Dosage of the comparative treatments

individual counselling with brief advice

iv Duration of the comparative treatments

lasting approximately 30-45 min each session, for 1 year

v Frequency of the comparative treatments

at most every 16 weeks, up to five individual counselling sessions in 1 yr

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients will be eligible if they were diagnosed as having type 2 DM for at least one year; aged 18-65 years with poor DM control (defined asHbA1C>= 8). Those with or without maximal dosages of oral hypoglycemic agents are equally eligible.

ii Exclusion Criteria

Pregnancy, severe debilitating disease that precludes adherence to recommendations (e.g., end stage cancer), cognitive deficit and medical conditions rendering the individuals incapable to complete informed consent or participate in the study.

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

pilot

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-09-17

21 Target Sample Size

20-25 each arm

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

HbA1c

ii The metric or method of measurement used

blood test

iii The timepoint(s) of primary interest

baseline, 6 months, 12 months

24 Secondary Outcome

i The Name of the outcome

systolic and diastolic blood pressure (BP), weight, body mass index (BMI), waist and hip circumference, fasting blood samples (fasting plasma glucose, total cholesterol, triglyceride, high-density lipoprotein (HDL) and low-density lipoprotein (LDL)), secondary psychosocial and self-care behaviour

ii The metric or method of measurement used

blood test, questionaires

iii The timepoint(s) of primary interest

baseline, 6 months, 12 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-09-05

27 Primary Registry and Trial Identifying Number

ChiCTR1800017414

28 Date of Registration in Primary Registry

2018-07-09

Back History

Trial Detail