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Completed

NCT Number: NCT02863523

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

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.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Behavioral Care

Behavioral

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.

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (%)

    Time frame: Baseline to 12 months

    Change from baseline in HbA1c or glycosylated hemoglobin (%)

Secondary outcomes

  1. Change From Baseline in Diabetes Regimen-Related Distress

    Time frame: 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.

Other outcomes

  1. Change in Diabetes Self-care Activities

    Time frame: Baseline to 12 months

    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.

  2. Change in Depressive Symptoms

    Time frame: Baseline to 12 months

    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

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Acronym: COMRADE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2016
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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