Translating Telephonic Diabetes Self-management Support to Primary Care Practice

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Telephonic Diabetes Self-Management Support; Other: Educational Print Materials

• Study Type: Interventional
• Enrollment (Actual): 812
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11101
      • New York City Department of Health and Mental Hygiene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Telephonic Diabetes Self-Management Support
Active Comparator: Educational Print Materials; Participants randomized to this arm will receive print materials on diabetes, glycemic control, self-management, and distress/depression.	Other: Educational Print Materials

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); New York City Department of Health and Mental Hygiene
• Investigators: Principal Investigator: Jeffrey S Gonzalez, PhD, Albert Einstein College Of Medicine; Principal Investigator: Winfred Y Wu, MD, MPH, New York City Department of Health and Mental Hygiene

Publications and helpful links

General Publications

• Gonzalez JS, Hoogendoorn CJ, Linnell J, Fishman S, Jonas V, Pham-Singer H, Schechter CB, Walker EA, Wu WY. Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support. Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 9, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Self-management; Treatment Adherence; Emotional Distress; Diabetes-related Distress
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2012-422; 1R18DK098742-01A1 (U.S. NIH Grant/Contract)