COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
- Conditions
- Diabetes-related DistressDepressionType 2 Diabetes Mellitus
- Registration Number
- NCT02863523
- Lead Sponsor
- East Carolina University
- Brief Summary
The study will implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression.
- Detailed Description
The investigators plan to implement and evaluate, using a pragmatic comparative effectiveness trial, a unique collaborative, stepped-care intervention for patients with uncontrolled Type 2 diabetes and co-morbid distress and/or depression. The investigators approach will combine practice-based medical and cognitive behavioral treatment with strong community-based support to immediately place the patient at the right level of intervention based on disease and severity and to step-up treatment intensity and follow-up if the initial response is inadequate. The practice-based component will use a care manager linked to medical, pharmacologic, and behavioral colleagues. The community based component will utilize community health workers to provide support and facilitate access to resources. Goals include: 1) implementing and evaluating the effectiveness of this intervention; 2) examining the impact of this approach on psychological mediators of improved glycosylated hemoglobin (HbA1c); and 3) building, sustaining, and disseminating a cost-effective care model.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- Clinical Diagnosis of Type 2 diabetes mellitus
- Glycosylated Hemoglobin (HbA1c) > 7.0 = Uncontrolled
- Positive score on diabetes related distress 2 question screener and/or
- Positive score on Patient Health Questionnaire (PHQ-2) 2 question screener
a diagnosis [from billing records using International Classification of Disease, 9th Edition (ICD-9) codes] of:
- advanced disease (e.g., end stage renal disease, advanced heart failure, blindness, metastatic cancer and including those who are in active treatment for cancer), or
- alcoholism or
- cognitive impairment, or
- major psychiatric disease or
- any type of physical or mental impairment that would preclude active participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Hemoglobin (%) Baseline to 12 months Change from baseline in HbA1c or glycosylated hemoglobin (%)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Diabetes Regimen-Related Distress Baseline to 12 months Diabetes regimen-related distress is a measure of the emotional response to having and managing diabetes and is measured by a subscale of 5 items (#5, 6, 10, 12, 16) from the Diabetes-related Distress instrument (DDS-17). Each item is rated from 1 (not a problem) - 6 (very serious problem) and therefore the total score for this sub-score ranges from 5 - 30. The mean score for an individual can be computed as the sum of the 5 items divided by 5. For this study outcome, the investigators computed the average change (increase or decrease) in the mean RRD score from baseline to 12-mo. follow-up.
Related Research Topics
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Trial Locations
- Locations (1)
East Carolina University
🇺🇸Greenville, North Carolina, United States
East Carolina University🇺🇸Greenville, North Carolina, United States