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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes self-management and education | Behavioral |
|
| 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 |
| 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 |
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Inclusion Criteria: Type 2 diabetes plus severe mental illness -
Exclusion Criteria: None
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| Name | Affiliation | Role |
|---|---|---|
| Gary S Cuddeback, Ph.D. | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| 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 |