Diabetes
Conditions
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.
Interventions
BEHAVIORALDiabetes self-management and education
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes plus severe mental illness -
Exclusion criteria
None \-
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | Bandura's exercise self-efficacy scale will be used. Bandura, A. (1997). Self-efficacy: The exercise of control. New York: W.H. Freeman. |
| 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 HBA1c values 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 | — |
| Changes in waist circumference from baseline to six months. | Baseline, 6 months | — |
Countries
United States
Outcome results
None listed