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Clinical Trials/NCT02053714
NCT02053714
Completed
Not Applicable

Improving Diabetes Outcomes for Persons With Severe Mental Illness

University of North Carolina, Chapel Hill1 site in 1 country18 target enrollmentDecember 2013
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of North Carolina, Chapel Hill
Enrollment
18
Locations
1
Primary Endpoint
Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 31, 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetes plus severe mental illness -

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in HBA1c values from baseline to six months.(Baseline, 6 months)
  • Changes in subscapular skinfold measurement from baseline to 6 months.(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.(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 body mass index 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 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 triceps circumference from baseline to six months.(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.(Baseline, 6 months)
  • Changes in diastolic and systolic blood pressure from baseline to six months.(Baseline, 6 months)

Study Sites (1)

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