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

NCT04120844 | Completed

• 1 other identifier: JCYJ20150331142757385
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabete Type 2

Keywords

Type 2 diabete; Motivational interviewing; Patient empowerment; Self-management; China

Outcome Measures

Primary Outcomes (1)

• Problem Areas in Diabetic (PAID) Questionnaire

  PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. A score of 40 or above is indicative of severe emotional distress.

  3 months

Secondary Outcomes (2)

• "Patient Enablement Index" (PEI) score

  3 months

• Stages of Change score

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in the intervention group (n=117) received a four-session PEP in small groups over one month by trained nurses and doctors.

Behavioral: Motivational interviewing (MI)-based patient empowerment program (PEP)

Control

PLACEBO COMPARATOR

The control group (n=108) received the traditional lecture-style health education on Diabetes Mellitus.

Behavioral: Traditional lecture style health education

Interventions

Motivational interviewing (MI)-based patient empowerment program (PEP) BEHAVIORAL

Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change. Counselors use empathy and other techniques to create an atmosphere to help patients to explore the discrepancies between the goals and their current behavior. 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. Program content was further informed by the Hospital Authority Patient Empowerment Program in Hong Kong. The education program consisted of four modules, held once a week, that each lasted approximately 1½ to 2 hours. They were grouped under the following four broad headings: Knowing Diabetes, Diabetes Self-Care, Healthy Diet and Physical Exercise.

Intervention

Traditional lecture style health education BEHAVIORAL

The control group received traditional lectures that consisted solely of conveying healthcare information to patients. In order to minimize intervention bias, the control group lectures were standardized and adapted into four modules, namely knowing diabetes, healthy diet, physical exercises, and how to use medication correctly, which were similar topic headings, durations and frequencies to those of the intervention group. Each lecture was 1 hour and was provided by one of four health professionals (a pharmacist, dietician, endocrinologist or nurse) who had never received any prior training in MI. We consciously avoided the inclusion of elements of self-reflection and motivation in these lectures.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes with HbA1c between 7-10%
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead

Related Publications (1)

• 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.

  PMID: 31973759 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Participation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jingya Yan

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Wei Liang

  The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.

  PRINCIPAL INVESTIGATOR

• Chen Qingqi

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Wong Chi Wai William

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Jennifer Li

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 9, 2019
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: September 26, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF