Translating Telephonic Diabetes Self-management Support to Primary Care Practice

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137720
• Other study ID #: 2012-422
• Secondary ID: 1R18DK098742-01A
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 20, 2019

Study information

• Verified date: July 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Telephonic Diabetes Self-Management Support

Other:
• Educational Print Materials

Locations

Country	Name	City	State
United States	New York City Department of Health and Mental Hygiene	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), New York City Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Obtained from electronic medical record.	Change from baseline at 12 months
Secondary	Diabetes Self-Management	Measured by self-report questionnaire	Change from baseline at 12 months
Secondary	Medication Adherence	Measured by self-report questionnaire	Change from baseline at 12 months
Secondary	Diabetes-related distress	Measured by self-report questionnaire	Change from baseline at 12 months
Secondary	Depressive symptoms	Measured by self-report questionnaire	Change from baseline at 12 months
Secondary	Blood pressure	Obtained from electronic medical record.	Baseline and 12 months
Secondary	Cholesterol	Obtained from electronic medical record.	Baseline and 12 months