Clinical trial NCT04120844: Effectiveness of Motivational Interviewing on Improving Care for Type 2 Diabetes Mellitus Patients in China
Official title: Effectiveness of Motivational Interviewing on Improving Care for Patients With Type 2 Diabetes in China: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Type 2
Keywords: Type 2 diabete
Motivational interviewing
Patient empowerment
Self-management
China
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The International Diabetes Federation estimated that there were nearly 110 million diabetes mellitus (DM) patients in China, which was the highest number recorded in the world. In response to the rising patient numbers and costs, the Chinese government has invested heavily in primary healthcare, with the goal of improving chronic disease management in the primary care settings. A key part of the primary care improvement program prioritizes health education as a route to lifestyle modification. Although the content and modes of delivery vary enormously, most of the programs focused on providing information rather than facilitating patient change. The impacts of traditional patient education on lifestyle modification and changes in psychological status have been reported to be suboptimal. It is therefore necessary to rethink and explore a more structured, patient-centered approach to health education at improving the outcomes of DM control.

Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change.The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Some studies show that MI can contribute to improve healthy eating, weight control and increases in physical activity, but most research focused on intermediate outcome measures and did not evaluate the readiness to change. MI can be utilized by a variety of healthcare providers, which makes it adaptable for different culture and clinical settings. The effectiveness of MI in Chinese diabetic patients remains uncertain.Therefore, in this study, we adopted the group MI approach and developed a patient empowerment program (PEP) utilizing the techniques and framework of MI. We compared this to the most common form of DM education in China, a lecture on DM to patients and their carers in a hospital lecture theatre in a didactic manner. The study aimed to assess the effectiveness of the MI approach in terms of patient lifestyle modification and improving DM controls compared to the control group in a non-blinded randomized controlled trial (RCT) design.

Detailed description: This RCT was implemented from May 2016 to April 2017 in Shenzhen, China. Shenzhen is the fourth-biggest city in China, with a rapidly expanding population of 12 million people and the highest GDP in the country. Most DM patients in China are managed at Endocrine Specialist hospital clinics, while the more stable patients are treated in the community. Therefore, we chose an endocrine specialist outpatient clinic and a family medicine clinic at the University of Hong Kong-Shenzhen Hospital (HKU-SZH), as well as three community health centers in the Luohu district as the sampling frame. DM patients were recruited by doctors at consultations. This is because health education lectures are one of the routine diabetes management strategies used by healthcare providers in China and patients are normally invited by their doctors to attend these lectures.

Sample size estimation was calculated based on the previous published research conducted elsewhere in which the DM patients were given MI-guided behavior change counselling. The "Problem Areas in Diabetes" (PAID) score in that study was 29±22.64 in the intervention group vs. 29±24.32 in the control group. Therefore, 192 participants were needed to detect 10% effect size with an alpha of 0.05 and a power of 80.0%. With 15% of loss to follow-up anticipated, a total of 225 participants were targeted.

Descriptive statistics were used to summarize characteristics of the participants. We analyzed the baseline data of the intervention and control groups to determine the consistency of the characteristics across the two groups of patients. The t-test was used for continuous variables such as waist circumference, body weight, and BMI, whereas chi-squared test was used for categorical variables in stages of change such as smoking, drinking, and exercise. Changes in PAID and PEI in post-intervention and follow-ups between the two groups were calculated and tested.

When analyzing the two sets of variables in the intervention and control groups, we followed the principle of intent-to-treat analysis i.e. if the participant failed to participate in all four modules, the first questionnaire results would be assumed and analyzed as the final data, using the mixed design analysis of variance. In detecting the relationship between the continuity variable and categorical variable, we used bivariate correlation analyses. All analyses were performed in SPSS 20.0. We used p value\<0.05 as the cut-off point of statistical significance.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes with HbA1c between 7-10%
* 18-75 years old
* No known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy
* Cognitively competent enough to understand written and the oral expression of the language native to the study site

Exclusion Criteria:

* Known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy
* Illiterate, or cognitively competent enough to understand written and the oral expression of the language native to the study site

Primary outcomes:
measure: Problem Areas in Diabetic (PAID) Questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: "Patient Enablement Index" (PEI) score
timeFrame: 3 months
measure: Stages of Change score
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Jingya Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.
name: Wei Liang
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Chen Qingqi
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Wong Chi Wai William
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Jennifer Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Z, Chen Q, Yan J, Liang W, Wong WCW. Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial. BMC Health Serv Res. 2020 Jan 23;20(1):57. doi: 10.1186/s12913-019-4776-8.