Back to resultsSelf-Determination Theory and Motivational Interviewing
Primary Purpose
Schizophrenia, Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Interviewing
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- patients with schizophrenia and Type 2 Diabetes
- between 20 years old to 80 years old
- can communicate in Chinese langue
Exclusion Criteria:
- can not communicate well
- have neurocognitive disorders
Sites / Locations
- Kaohsiung Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
The researcher interviews with participants for 3 times.
The participants receive usual care.
Outcomes
Primary Outcome Measures
HbA1C
Blood sugar level during the 3 months
Body weight
weight (in kilograms)
height
height (in meters), eight and height will be combined to report BMI in kg/m^2
Secondary Outcome Measures
Brief Psychiatric Rating Scale
The Brief Psychiatric Rating Scale with 18 items is use to measure psychiatric symptoms. Each symptom is rated 1-7 with higher scores indicating severer symptoms.
Treatment Self-Regulation Questionnaire-Diabetes
The treatment Self-Regulation Questionnaire-Diabetes a 19-item scale used to examine the self-regulation behaviors for diabetes of participants. Each item is ranged from 1 to 7 and higher scores showing more motivations in self-regulation diabetes.
Perceived Diabetes Self-Management Scale
The Perceived Diabetes Self-Management Scale is an 8-item scale with 4 of the items (1, 2, 6, & 7) being reverse-scored. Each item is ranged from 1 to 5 and higher scores showing more confidence in self-managing diabetes.
Depression Anxiety Stress Scales
The Depression Anxiety Stress Scales is a self-report scale with 21 items designed to assess depression, stress and anxiety of participants. Scores for each symptom is ranged from 0 to 3 with higher scores indicating severer symptoms.
Full Information
NCT ID
NCT04611737
First Posted
October 25, 2020
Last Updated
November 5, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04611737
Brief Title
Self-Determination Theory and Motivational Interviewing
Official Title
Developing and Testing of Integrating Self-Determination Theory and Motivational Interviewing Based Diabetic Self-management Program Among Schizophrenic Patients With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial 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
Self-Determination Theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes.
Detailed Description
Participants would be randomly allocated into either the intervention group or the usual care group from baseline to 3 months follow-up. The intervention is based on integrated self-determination theory and motivational interviewing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The researcher interviews with participants for 3 times.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Interviewing
Intervention Description
Self-Determination Theory within motivational interviewing
Primary Outcome Measure Information:
Title
HbA1C
Description
Blood sugar level during the 3 months
Time Frame
on interviewing day1, and 3 months
Title
Body weight
Description
weight (in kilograms)
Time Frame
on interviewing day1, and 3 months
Title
height
Description
height (in meters), eight and height will be combined to report BMI in kg/m^2
Time Frame
on interviewing day1, and 3 months
Secondary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale
Description
The Brief Psychiatric Rating Scale with 18 items is use to measure psychiatric symptoms. Each symptom is rated 1-7 with higher scores indicating severer symptoms.
Time Frame
on interviewing day1, and 3 months
Title
Treatment Self-Regulation Questionnaire-Diabetes
Description
The treatment Self-Regulation Questionnaire-Diabetes a 19-item scale used to examine the self-regulation behaviors for diabetes of participants. Each item is ranged from 1 to 7 and higher scores showing more motivations in self-regulation diabetes.
Time Frame
on interviewing day1, and 3 months
Title
Perceived Diabetes Self-Management Scale
Description
The Perceived Diabetes Self-Management Scale is an 8-item scale with 4 of the items (1, 2, 6, & 7) being reverse-scored. Each item is ranged from 1 to 5 and higher scores showing more confidence in self-managing diabetes.
Time Frame
on interviewing day1, and 3 months
Title
Depression Anxiety Stress Scales
Description
The Depression Anxiety Stress Scales is a self-report scale with 21 items designed to assess depression, stress and anxiety of participants. Scores for each symptom is ranged from 0 to 3 with higher scores indicating severer symptoms.
Time Frame
on interviewing day1, and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with schizophrenia and Type 2 Diabetes
between 20 years old to 80 years old
can communicate in Chinese langue
Exclusion Criteria:
can not communicate well
have neurocognitive disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Yun Yu, PhD
Phone
8863121101
Ext
2608
Email
cyyu@kmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chien Yu Lai, PhD
Phone
88628227101
Ext
3141
Email
chienlai@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Yun Yu, PhD
Organizational Affiliation
Assistant professor, School of Nursing, Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching Y Yu, PhD
Phone
88673121101
Ext
2608
Email
cyyu@kmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chien Yu Lai, PhD
Phone
88628227101
Ext
3114
Email
chienlai@ntunhs.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Self-Determination Theory and Motivational Interviewing
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