Translating Telephonic Diabetes Self-management Support to Primary Care Practice

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Educational Print Materials; Behavioral: Telephonic Diabetes Self-Management Support

• Registration Number: NCT02137720
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-14
• Study Start: 2014-06
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 812

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Print Materials	Educational Print Materials	Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression.
Telephonic Diabetes Self-Management Support	Telephonic Diabetes Self-Management Support	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.

Primary Outcome Measures

Name	Time	Method
HbA1c	Change from baseline at 12 months	Obtained from electronic medical record.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York City Department of Health and Mental Hygiene; 🇺🇸 New York, New York, United States