N/A N=139 Randomized Treatment

COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes

Type 2 Diabetes Mellitus · Diabetes-related Distress · Depression

Bottom Line

View on ClinicalTrials.gov: NCT02863523 ↗

Enrolled (actual)

139

Serious AEs

0.0%

Results posted

Dec 2023

Primary outcome: Primary: Change From Baseline in Glycosylated Hemoglobin (%) — -0.92; -0.31 change from baseline in A1c (%)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Integrated Behavioral Care (Behavioral)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: East Carolina University
Primary completion: Dec 2017

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

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.

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

View full record on ClinicalTrials.gov →

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.