Improving Diabetes Outcomes for Persons With Severe Mental Illness

NCT02053714 | Completed

• 1 other identifier: 13-3211
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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.

  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 healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.

  Baseline, 6 months

Study Arms (1)

Self-management and education group

OTHER

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

Interventions

Diabetes self-management and education BEHAVIORAL

Self-management and education group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Gary S Cuddeback, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: February 4, 2014
• Study Start: December 1, 2013
• Primary Completion: June 15, 2015
• Study Completion: December 31, 2015
• Last Updated: May 9, 2017

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)