Translating Telephonic Diabetes Self-management Support to Primary Care Practice

Study Overview
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Brief Summary
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The goal of this study is to evaluate the implementation and effectiveness of an intervention to improve diabetes self-management, emotional distress and metabolic control among adults with type 2 diabetes receiving care in primary care practices throughout New York City. The program will be implemented by the New York City Department of Health, through their Primary Care Improvement Project.

Official Title
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Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Telephonic Diabetes Self-Management Support
* Other: Educational Print Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years of age and older Receiving treatment for diabetes at selected primary care practices throughout New York City Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization) Ability to speak and read English or Spanish (or someone in the household who will read to them) Access to a telephone Willing to give informed consent to participate and accept random assignment. Exclusion Criteria: Stated intention to move out of the New York City area during the next year Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff Treatment provider deems that the patient is inappropriate for the trial

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephonic Diabetes Self-Management Support<br>This group receives all the Educational Print Materials received by the comparison condition plus telephone calls from a health educator to provide tailored diabetes self-management training and support. Participants with significant emotional distress at baseline also receive additional calls focused on distress management. | Behavioral: Telephonic Diabetes Self-Management Support<br> <br> |
| Active Comparator: Educational Print Materials<br>Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression. | Other: Educational Print Materials<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Obtained from electronic medical record. | Change from baseline at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Self-Management | Measured by self-report questionnaire | Change from baseline at 12 months | 
| Medication Adherence | Measured by self-report questionnaire | Change from baseline at 12 months | 
| Diabetes-related distress | Measured by self-report questionnaire | Change from baseline at 12 months | 
| Depressive symptoms | Measured by self-report questionnaire | Change from baseline at 12 months | 
| Blood pressure | Obtained from electronic medical record. | Baseline and 12 months | 
| Cholesterol | Obtained from electronic medical record. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Treatment Adherence, Self-management, Emotional Distress, Diabetes-related Distress