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Clinical Trials/NCT02137720
NCT02137720
Completed
Not Applicable

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

Albert Einstein College of Medicine1 site in 1 country812 target enrollmentJune 2014
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ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Albert Einstein College of Medicine
Enrollment
812
Locations
1
Primary Endpoint
HbA1c
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
September 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Gonzalez

Associate Professor

Albert Einstein College of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

HbA1c

Time Frame: Change from baseline at 12 months

Obtained from electronic medical record.

Secondary Outcomes

  • Medication Adherence(Change from baseline at 12 months)
  • Diabetes-related distress(Change from baseline at 12 months)
  • Depressive symptoms(Change from baseline at 12 months)
  • Cholesterol(Baseline and 12 months)
  • Diabetes Self-Management(Change from baseline at 12 months)
  • Blood pressure(Baseline and 12 months)

Study Sites (1)

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