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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: Motivational interviewing Placebo Comparator: Traditional lectures
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, 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

Exclusion Criteria:

  • Known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy, Illiterate or not 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

    Motivational interviewing

    Traditional lectures

    Arm Description

    The intervention group received an education program in small groups that included no more than ten members. The content was designed based on MI theory and the theory of patient empowerment. 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. Each module started with a brief introduction to relevant background knowledge, which was followed by small-group discussions about personal barriers and techniques for overcoming challenges. During the small group discussions, educators acted as MI facilitators, using group MI techniques to strengthen participants' motivation.

    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.

    Outcomes

    Primary Outcome Measures

    Problem Areas in Diabetes Questionnaire
    PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The PAID scale has been widely used in many countries to assess diabetes-related 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. The PEI scale had been validated in the Chinese population.
    Stages of Change score
    The Stages of Change score is a score that assess participants' readiness to change in behaviors such as smoking, drinking or exercise and their adherence to treatment.

    Full Information

    First Posted
    March 30, 2020
    Last Updated
    April 17, 2020
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04342845
    Brief Title
    Effectiveness of Motivational Interviewing on Improving Care for Patients With Type 2 Diabetes 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
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    September 24, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    n 2015, 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. China's DM-related costs, ranked second highest globally, were estimated to be US$51 billion. In response to the rising patient numbers and costs, the Chinese government has invested heavily in primary healthcare since 2009, 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. These may be related to the poor understanding of the educational content or lack of means for making changes as a result of low socioeconomic status and poor educational level. 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. 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. 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. However, the effectiveness of MI in Chinese diabetic patients remains uncertain. MI has been delivered using different methods. These methods have varied and included a single one-to-one session with a therapist, multiple group sessions, and the incorporation of MI into daily clinical practice. Furthermore, in yet another study, MI education program produced a significantly greater change in patients' perceived competence in dealing with diabetes than the control group. In this study, the investigators adopted the group MI approach and developed a patient empowerment program (PEP) utilizing the techniques and framework of MI. The investigators compared this to the most common form of DM education in China, i.e., when health professionals (nurses, doctors, dietitians or pharmacists) give a lecture on DM to patients and their carers in a hospital lecture theatre in a didactic manner.
    Detailed Description
    Background: To assess the effects of a motivational interviewing (MI)-based patient empowerment program (PEP) on type 2 diabetes mellitus (DM) patient self-management compared to traditional diabetes health education. Methods: Two hundred and twenty-five patients, recruited from community health centers (CHCs) and the family medicine clinic in the University of Hong Kong-Shenzhen Hospital in Shenzhen, were randomly assigned to the intervention or control groups. 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 DM. All the patients were followed up for three months. Outcomes included problem areas in diabetes (PAID) that measures diabetes-related emotional distress, patient enablement index (PEI), mental health, patient satisfaction respectively as well as lifestyle behaviors were assessed at baseline, post-activity and three months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Diabetes Mellitus, Type 2, Motivational interviewing, Patient empowerment, Self-management, China

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two hundred and twenty-five patients, recruited from community health centers (CHCs) and the family medicine clinic in the University of Hong Kong-Shenzhen Hospital in Shenzhen, were randomly assigned to the intervention or control groups. Patients in the intervention group (n = 117) received a four-session PEP in small groups over 1 month by trained nurses and doctors. The control group (n = 108) received the traditional lecture-style health education on DM. All the patients were followed up for 3 months. Outcomes included problem areas in diabetes (PAID) that measures diabetes-related emotional distress, patient enablement index (PEI), mental health, patient satisfaction respectively as well as lifestyle behaviors were assessed at baseline, post-activity and 3 months.
    Masking
    Participant
    Masking Description
    Upon receiving a participant's consent form, the independent administrative research assistant would generate a random number by computer to determine allocation to the intervention or control group. For concealment purposes, there was no medical information relating to the participant on the consent form. The assistant only informed participants of their attendance time and not of their grouping. We used the blocked randomization by number "8" which guaranteed that there were four people in both groups in each of the eight people. This method can avoid overbalance between two groups as there might be some people missing halfway.
    Allocation
    Randomized
    Enrollment
    225 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Motivational interviewing
    Arm Type
    Experimental
    Arm Description
    The intervention group received an education program in small groups that included no more than ten members. The content was designed based on MI theory and the theory of patient empowerment. 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. Each module started with a brief introduction to relevant background knowledge, which was followed by small-group discussions about personal barriers and techniques for overcoming challenges. During the small group discussions, educators acted as MI facilitators, using group MI techniques to strengthen participants' motivation.
    Arm Title
    Traditional lectures
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Experimental: Motivational interviewing Placebo Comparator: Traditional lectures
    Intervention Description
    Patients in the intervention group (n=117) received a four-session patient empowerment program in small groups over one month by trained nurses and doctors. he control group received traditional lectures that consisted solely of conveying healthcare information to patients.
    Primary Outcome Measure Information:
    Title
    Problem Areas in Diabetes Questionnaire
    Description
    PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The PAID scale has been widely used in many countries to assess diabetes-related emotional distress.
    Time Frame
    4 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. The PEI scale had been validated in the Chinese population.
    Time Frame
    4 months
    Title
    Stages of Change score
    Description
    The Stages of Change score is a score that assess participants' readiness to change in behaviors such as smoking, drinking or exercise and their adherence to treatment.
    Time Frame
    4 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 Exclusion Criteria: Known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy, Illiterate or not 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
    WHO Health Promoting Hospital Office, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Wei Liang
    Organizational Affiliation
    Endocrinology Department, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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

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