Improving Diabetes Outcomes for Persons With Severe Mental Illness

Diabetes Clinical Trial

Official title:

Improving Diabetes Outcomes for Persons With Severe Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053714
• Other study ID #: 13-3211
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: May 7, 2017
• Start date: December 2013
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2015
• Est. primary completion date: June 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: Type 2 diabetes plus severe mental illness -

Exclusion Criteria: None

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Mental Disorders

Intervention

Behavioral:
• Diabetes self-management and education

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in HBA1c values from baseline to six months.		Baseline, 6 months
Secondary	Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.		Baseline, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in waist circumference from baseline to six months.		Baseline, 6 months
Secondary	Changes in triceps circumference from baseline to six months.		Baseline, 6 months
Secondary	Changes in subscapular skinfold measurement from baseline to 6 months.		Baseline, 6 months
Secondary	Changes in body mass index from baseline to six months.		Baseline, 6 months
Secondary	Changes in diastolic and systolic blood pressure from baseline to six months.		Baseline, 6 months