Effectiveness of Motivational Interviewing on Improving Care for Type 2 Diabetes Mellitus Patients in China
Primary Purpose
Diabete Type 2
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational interviewing (MI)-based patient empowerment program (PEP)
Traditional lecture style health education
Sponsored by

About this trial
This is an interventional health services research trial for Diabete Type 2 focused on measuring Type 2 diabete, Motivational interviewing, Patient empowerment, Self-management, China
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Patients in the intervention group (n=117) received a four-session PEP in small groups over one month by trained nurses and doctors.
The control group (n=108) received the traditional lecture-style health education on Diabetes Mellitus.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
"Patient Enablement Index" (PEI) score
The PEI is a scale that measures patients' enablement, it was also used to measure patient enablement in this study.Subjects with PEI total score> 0 are considered to have enablement over the past 12-month period, while those with PEI total score = 0 were considered to have no enablement over the period. The PEI scale had been validated in the Chinese population.
Stages of Change score
Motivation for lifestyle change was measured in this study based on the "Stages of Change" model to assess participants' readiness to change in behaviors such as smoking, drinking or exercise and their adherence to treatment. The mean stage-of-change score may be a more stable estimate of stage of change.
Full Information
NCT ID
NCT04120844
First Posted
September 26, 2019
Last Updated
October 7, 2019
Sponsor
The University of Hong Kong-Shenzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04120844
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
September 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong-Shenzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2
Keywords
Type 2 diabete, Motivational interviewing, Patient empowerment, Self-management, China
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients in the intervention group (n=117) received a four-session PEP in small groups over one month by trained nurses and doctors.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control group (n=108) received the traditional lecture-style health education on Diabetes Mellitus.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing (MI)-based patient empowerment program (PEP)
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Traditional lecture style health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Problem Areas in Diabetic (PAID) Questionnaire
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
"Patient Enablement Index" (PEI) score
Description
The PEI is a scale that measures patients' enablement, it was also used to measure patient enablement in this study.Subjects with PEI total score> 0 are considered to have enablement over the past 12-month period, while those with PEI total score = 0 were considered to have no enablement over the period. The PEI scale had been validated in the Chinese population.
Time Frame
3 months
Title
Stages of Change score
Description
Motivation for lifestyle change was measured in this study based on the "Stages of Change" model to assess participants' readiness to change in behaviors such as smoking, drinking or exercise and their adherence to treatment. The mean stage-of-change score may be a more stable estimate of stage of change.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingya Yan
Organizational Affiliation
The University of Hong Kong-Shenzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Liang
Organizational Affiliation
The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chen Qingqi
Organizational Affiliation
The University of Hong Kong-Shenzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wong Chi Wai William
Organizational Affiliation
The University of Hong Kong-Shenzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Li
Organizational Affiliation
The University of Hong Kong-Shenzhen Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Subject to principal investigator's approval
Citations:
PubMed Identifier
31973759
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.
Results Reference
derived
Learn more about this trial
Effectiveness of Motivational Interviewing on Improving Care for Type 2 Diabetes Mellitus Patients in China
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