Improving Diabetes Outcomes for Persons With Severe Mental Illness

Study Overview
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Brief Summary
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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.

Official Title
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Improving Diabetes Outcomes for Persons With Severe Mental Illness

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Diabetes self-management and education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes plus severe mental illness - Exclusion Criteria: None -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Self-management and education group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |