NCT04120844

Effectiveness of Motivational Interviewing on Improving Care for Type 2 Diabetes Mellitus Patients in China

Completed NA Last updated 9 October 2019

What this trial tests

NA trial testing Motivational interviewing (MI)-based patient empowerment program (PEP) in Diabete Type 2 in 225 participants. Completed in 26 September 2019.

Timeline

1 May 2016

Primary endpoint
1 April 2017

26 September 2019

Quick facts

Lead sponsor	The University of Hong Kong-Shenzhen Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	225
Start date	1 May 2016
Primary completion	1 April 2017
Estimated completion	26 September 2019

Drugs / interventions tested

• Motivational interviewing (MI)-based patient empowerment program (PEP)
• Traditional lecture style health education

Conditions studied

• Diabete Type 2 — all drugs for Diabete Type 2 →

Sponsor

The University of Hong Kong-Shenzhen Hospital

Who can join

Adults 18 to 75, any sex, with Diabete Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial.
   Li Z, Chen Q, Yan J, Liang W, et al · · 2020 · cited 17× · PMID 31973759 · DOI 10.1186/s12913-019-4776-8