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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
The University of Hong Kong-Shenzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 26, 2019
    Last Updated
    October 7, 2019
    Sponsor
    The University of Hong Kong-Shenzhen Hospital
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    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

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

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