COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
COMRADE
1 other identifier
interventional
139
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Sep 2014
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
December 8, 2023
CompletedDecember 8, 2023
March 1, 2023
3.3 years
August 3, 2016
February 14, 2019
March 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (%)
Change from baseline in HbA1c or glycosylated hemoglobin (%)
Baseline to 12 months
Secondary Outcomes (1)
Change From Baseline in Diabetes Regimen-Related Distress
Baseline to 12 months
Other Outcomes (2)
Change in Diabetes Self-care Activities
Baseline to 12 months
Change in Depressive Symptoms
Baseline to 12 months
Study Arms (2)
Integrated Behavioral Intervention
EXPERIMENTALPatients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Usual Care
NO INTERVENTIONPatients receive usual care
Interventions
Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East Carolina Universitylead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
East Carolina University
Greenville, North Carolina, 27834, United States
Related Publications (3)
Cummings DM, Lutes LD, Littlewood K, Solar C, Carraway M, Kirian K, Patil S, Adams A, Ciszewski S, Edwards S, Gatlin P, Hambidge B. Randomized Trial of a Tailored Cognitive Behavioral Intervention in Type 2 Diabetes With Comorbid Depressive and/or Regimen-Related Distress Symptoms: 12-Month Outcomes From COMRADE. Diabetes Care. 2019 May;42(5):841-848. doi: 10.2337/dc18-1841. Epub 2019 Mar 4.
PMID: 30833367BACKGROUNDLutes LD, Cummings DM, Littlewood K, Le MT, Kirian K, Patil S, Solar C, Carraway M, Hambidge B. A Tailored Cognitive-Behavioural Intervention Produces Comparable Reductions in Regimen-Related Distress in Adults With Type 2 Diabetes Regardless of Insulin Use: 12-Month Outcomes From the COMRADE Trial. Can J Diabetes. 2020 Aug;44(6):530-536. doi: 10.1016/j.jcjd.2020.05.016. Epub 2020 Jun 10.
PMID: 32792107BACKGROUNDLutes LD, Cummings DM, Littlewood K, Solar C, Carraway M, Kirian K, Patil S, Adams A, Ciszewski S, Hambidge B. COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US. Contemp Clin Trials. 2018 Jul;70:8-14. doi: 10.1016/j.cct.2018.04.007. Epub 2018 Apr 20.
PMID: 29680319RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Adverse event detection was limited to events potentially associated with behavioral counseling.
Results Point of Contact
- Title
- Dr. Doyle Cummings
- Organization
- East Carolina University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Family Medicine
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 11, 2016
Study Start
September 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 8, 2023
Results First Posted
December 8, 2023
Record last verified: 2023-03