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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | No Intervention | Patients receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (%) | Change from baseline in HbA1c or glycosylated hemoglobin (%) | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria: a diagnosis [from billing records using International Classification of Disease, 9th Edition (ICD-9) codes] of:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30833367 | Background | 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. | |
| 32792107 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Integrated Behavioral Intervention | 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. 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. |
| FG001 | Usual Care | Patients receive usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Integrated Behavioral Intervention | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (%) | Change from baseline in HbA1c or glycosylated hemoglobin (%) | Posted | Mean | Standard Deviation | change from baseline in A1c (%) | Baseline to 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Integrated Behavioral Intervention | 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. 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. |
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Adverse event detection was limited to events potentially associated with behavioral counseling.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Doyle Cummings | East Carolina University | 252-744-2607 | FLOYDS14@ecu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2017 | Mar 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline to 12 months |
| Baseline to 12 months |
| 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 |
| Background |
| 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. |
| 29680319 | Result | 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 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. |
| BG001 | Usual Care | Patients receive usual care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | percent |
|
Patients receive usual care
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
|
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
|
|
|
|
| Other Pre-specified | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 months |
|
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Usual Care | Patients receive usual care | 0 | 72 | 0 | 72 | 0 | 72 |
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| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |