N/A
Completed N=139
COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
Type 2 Diabetes Mellitus · Diabetes-related Distress · Depression
Source: ClinicalTrials.gov NCT02863523 ↗
Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (%) — -0.92; -0.31 change from baseline in A1c (%)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (%) |
-0.92; -0.31 | — |
| SECONDARY Change From Baseline in Diabetes Regimen-Related Distress |
-1.1; -0.3 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria: 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
Data sourced from ClinicalTrials.gov (NCT02863523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.