Improving Diabetes Outcomes for Persons With Severe Mental Illness
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes self-management and education
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes plus severe mental illness -
Exclusion Criteria: None
-
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Self-management and education group
Arm Description
Self-management and education group - 8 weeks of group-based information and activities designed to improve diabetes self-management
Outcomes
Primary Outcome Measures
Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.
Secondary Outcome Measures
Changes in HBA1c values from baseline to six months.
Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.
Changes in eating self-efficacy from baseline to six months as evidenced by scores on a standardized measure of eating self-efficacy.
Glynn and Ruderman's (1986) eating self-efficacy scale will be used.
Glynn, S.M., & Ruderman, J. (1986). The development and validation of an eating self-efficacy scale. Cognitive Therapy and Research, 10, 403-420.
Changes in exercise self-efficacy from baseline to six months as evidenced by scores on a standardized measure of exercise self-efficacy.
Bandura's exercise self-efficacy scale will be used. Bandura, A. (1997). Self-efficacy: The exercise of control. New York: W.H. Freeman.
Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.
Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities.
Changes in waist circumference from baseline to six months.
Changes in triceps circumference from baseline to six months.
Changes in subscapular skinfold measurement from baseline to 6 months.
Changes in body mass index from baseline to six months.
Changes in diastolic and systolic blood pressure from baseline to six months.
Full Information
NCT ID
NCT02053714
First Posted
January 21, 2014
Last Updated
May 7, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
1. Study Identification
Unique Protocol Identification Number
NCT02053714
Brief Title
Improving Diabetes Outcomes for Persons With Severe Mental Illness
Official Title
Improving Diabetes Outcomes for Persons With Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 15, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
North Carolina Translational and Clinical Sciences Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM). Unfortunately, persons with mental illness and T2DM are less likely to receive recommended diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to microvascular and macrovascular complications later in life. Evidence-based diabetes self-management education and support interventions have yet to be adapted for persons with mental illness and there have been no randomized controlled trials (RCTs) to examine their feasibility and efficacy. The purpose of this study is to assess the feasibility of conducting a RCT of a diabetes self-management intervention for persons with severe mental illness and T2DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-management and education group
Arm Type
Other
Arm Description
Self-management and education group - 8 weeks of group-based information and activities designed to improve diabetes self-management
Intervention Type
Behavioral
Intervention Name(s)
Diabetes self-management and education
Primary Outcome Measure Information:
Title
Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Changes in HBA1c values from baseline to six months.
Time Frame
Baseline, 6 months
Title
Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.
Time Frame
Baseline, 6 months
Title
Changes in eating self-efficacy from baseline to six months as evidenced by scores on a standardized measure of eating self-efficacy.
Description
Glynn and Ruderman's (1986) eating self-efficacy scale will be used.
Glynn, S.M., & Ruderman, J. (1986). The development and validation of an eating self-efficacy scale. Cognitive Therapy and Research, 10, 403-420.
Time Frame
Baseline, 6 months
Title
Changes in exercise self-efficacy from baseline to six months as evidenced by scores on a standardized measure of exercise self-efficacy.
Description
Bandura's exercise self-efficacy scale will be used. Bandura, A. (1997). Self-efficacy: The exercise of control. New York: W.H. Freeman.
Time Frame
Baseline, 6 months
Title
Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.
Time Frame
Baseline, 6 months
Title
Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities.
Time Frame
Baseline, 6 months
Title
Changes in waist circumference from baseline to six months.
Time Frame
Baseline, 6 months
Title
Changes in triceps circumference from baseline to six months.
Time Frame
Baseline, 6 months
Title
Changes in subscapular skinfold measurement from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Changes in body mass index from baseline to six months.
Time Frame
Baseline, 6 months
Title
Changes in diastolic and systolic blood pressure from baseline to six months.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes plus severe mental illness -
Exclusion Criteria: None
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary S Cuddeback, Ph.D.
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Diabetes Outcomes for Persons With Severe Mental Illness
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