Type 2 Diabetes MellitusCOMRADENCT02863523
COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
A study testing Integrated Behavioral Care in people with Type 2 Diabetes Mellitus and Diabetes-related Distress, run by East Carolina University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes-related Distress, Depression
- What is being tested?
- Integrated Behavioral Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- alcoholism or
- cognitive impairment, or
- major psychiatric disease or
- any type of physical or mental impairment that would preclude active participation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
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.
Read the detailed 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.
- Being tested
- Integrated Behavioral Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Behavioral CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Behavioral Intervention | Experimental | 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. Receives: Behavioral: Integrated Behavioral Care |
| Usual Care | No intervention | Patients receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin (%)
Change from baseline in HbA1c or glycosylated hemoglobin (%)
Measured: Baseline to 12 months
Secondary outcomes (1)
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Doyle M. Cummings, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863523
- Sponsor's protocol ID
- COMRADE
- Acronym
- COMRADE
- Status last verified
- Mar 2023
- First submitted
- 3 Aug 2016
- Last updated
- 8 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30833367Lutes 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.
PubMed 32792107Lutes 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.
PubMed 29680319
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
- ClinicalTrials.gov ID
- NCT02863523
- Acronym / sponsor ID
- COMRADE / COMRADE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Posted 8 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Behavioral Intervention | Experimental | Behavioral: Integrated Behavioral CarePatients 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 intervention | –Patients receive usual care |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Behavioral CarePatients 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. | Behavioural | Integrated Behavioral Intervention |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (%)
Time frame: Baseline to 12 months
Change from baseline in HbA1c or glycosylated hemoglobin (%)
1 secondary outcome
Change From Baseline in Diabetes Regimen-Related Distress
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30833367Cummings 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.
- Background: PubMed 32792107Lutes 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.
- Results publication: PubMed 29680319Lutes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Behavioral Care in people with Type 2 Diabetes Mellitus and Diabetes-related Distress, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Glycosylated Hemoglobin (%) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02863523, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.