Translating Telephonic Diabetes Self-management Support to Primary Care Practice

Albert Einstein College of Medicine

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Educational Print Materials; Behavioral: Telephonic Diabetes Self-Management Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02137720

1R18DK098742-01A1 (U.S. NIH Grant/Contract)

2012-422

Details and patient eligibility

About

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.

Enrollment: 812 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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812 participants in 2 patient groups

Telephonic Diabetes Self-Management Support

Experimental group

Description:

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.

Treatment:

Behavioral: Telephonic Diabetes Self-Management Support

Educational Print Materials

Active Comparator group

Description:

Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression.

Treatment:

Other: Educational Print Materials