Improving Diabetes Outcomes for Persons With Severe Mental Illness

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Diabetes self-management and education

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Type 2 diabetes plus severe mental illness -

Exclusion Criteria: None

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Self-management and education group; Self-management and education group - 8 weeks of group-based information and activities designed to improve diabetes self-management	Behavioral: Diabetes self-management and education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HBA1c values from baseline to six months.		Baseline, 6 months
Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.		Baseline, 6 months
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.	Baseline, 6 months
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.	Baseline, 6 months
Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.		Baseline, 6 months
Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities.		Baseline, 6 months
Changes in waist circumference from baseline to six months.		Baseline, 6 months
Changes in triceps circumference from baseline to six months.		Baseline, 6 months
Changes in subscapular skinfold measurement from baseline to 6 months.		Baseline, 6 months
Changes in body mass index from baseline to six months.		Baseline, 6 months
Changes in diastolic and systolic blood pressure from baseline to six months.		Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Gary S Cuddeback, Ph.D., University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 15, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 7, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Mental Disorders
• Other Study ID Numbers: 13-3211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO