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

Depression Clinical Trial

— COMRADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863523
• Other study ID #: COMRADE
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Clinical Diagnosis of Type 2 diabetes mellitus

2. Glycosylated Hemoglobin (HbA1c) > 7.0 = Uncontrolled

3. Positive score on diabetes related distress 2 question screener and/or

4. 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:

1. 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

2. alcoholism or

3. cognitive impairment, or

4. major psychiatric disease or

5. any type of physical or mental impairment that would preclude active participation

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes-related Distress
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Integrated Behavioral Care
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.

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
East Carolina University	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Lutes 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. — View Citation

Lutes 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 dis — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Diabetes Self-care Activities	Diabetes self-care activities as measured by the Self-reported Diabetes Self Care Activities (SDSCA) instrument. The SDSCA is a questionnaire which assesses levels of self-care in adults with diabetes. The tool contains 11 items, which measure the frequency of performing diabetes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The respondent marks the number of days on which the indicated behavior was performed on an eight-point Likert scale (0 - 7) to answer the questions. The first ten items are summed to a total score. The eleventh item focuses on smoking habits and assesses the average number of cigarettes smoked per day. For the present study, the total score was summed and divided by 11 items to create a mean score and then the average change from baseline to 12 month follow-up.	Baseline to 12 months
Other	Change in Depressive Symptoms	Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) instrument for depressive symptoms. Diagnosis based on Total PHQ-9 Score; Interpretation: Minimal depression 0-4 Mild depression 5-9 Moderate depression 10-14 Moderately severe depression 15-19 Severe depression 20-27	Baseline to 12 months
Primary	Change From Baseline in Glycosylated Hemoglobin (%)	Change from baseline in HbA1c or glycosylated hemoglobin (%)	Baseline to 12 months
Secondary	Change From Baseline in Diabetes Regimen-Related Distress	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.	Baseline to 12 months