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Trial Detail

CUHK_CCRB00614

2018-07-09

Prospective

NTWC/CREC/18038

Hong Kong College of Family Physician

N/A

N/A

Not Applicable

Man Kin Wong

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

24685111

wmk902@ha.org.hk

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

Hong Kong

Man Kin Wong

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

24685111

wmk902@ha.org.hk

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

Hong Kong

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

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

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

Hong Kong SAR

Yes

2018-07-03

New Territories West Cluster Research Ethics Committee

NTWC/CREC/18038

Diabetes

Behavior

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.

Motivational interviewing

based on MI spirits, avoid righting reflex and advice

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

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

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.

usual care

individual counselling with brief advice

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

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

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.

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.

18

65

Both Male and Female

Interventional

Randomized

pilot

Active

Single-blind

Trial subjects

Parallel

1

2018-09-17

20-25 each arm

Complete

HbA1c

blood test

baseline, 6 months, 12 months

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

blood test, questionaires

baseline, 6 months, 12 months

No

2019-09-05

ChiCTR1800017414

2018-07-09

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