Clinical trial NCT02053714: Improving Diabetes Outcomes for Persons With Severe Mental Illness
Official title: Improving Diabetes Outcomes for Persons With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2014-02-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria: Type 2 diabetes plus severe mental illness -

Exclusion Criteria: None

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Primary outcomes:
measure: Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Changes in HBA1c values from baseline to six months.
timeFrame: Baseline, 6 months
measure: Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.
timeFrame: Baseline, 6 months
measure: Changes in eating self-efficacy from baseline to six months as evidenced by scores on a standardized measure of eating self-efficacy.
timeFrame: Baseline, 6 months
measure: Changes in exercise self-efficacy from baseline to six months as evidenced by scores on a standardized measure of exercise self-efficacy.
timeFrame: Baseline, 6 months
measure: Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.
timeFrame: Baseline, 6 months
measure: Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities.
timeFrame: Baseline, 6 months
measure: Changes in waist circumference from baseline to six months.
timeFrame: Baseline, 6 months
measure: Changes in triceps circumference from baseline to six months.
timeFrame: Baseline, 6 months
measure: Changes in subscapular skinfold measurement from baseline to 6 months.
timeFrame: Baseline, 6 months
measure: Changes in body mass index from baseline to six months.
timeFrame: Baseline, 6 months
measure: Changes in diastolic and systolic blood pressure from baseline to six months.
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gary S Cuddeback, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: