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OpenTrials
Completed

NCT Number: NCT02137720

Translating Telephonic Diabetes Self-management Support to Primary Care Practice

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.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Treatment Adherence and Compliance

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York City Department of Health and Mental Hygiene

New York, 11101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephonic Diabetes Self-Management Support

Behavioral

Educational Print Materials

Other

Primary outcomes

  1. HbA1c

    Time frame: Change from baseline at 12 months

    Obtained from electronic medical record.

Secondary outcomes

  1. Diabetes Self-Management

    Time frame: Change from baseline at 12 months

    Measured by self-report questionnaire

  2. Medication Adherence

    Time frame: Change from baseline at 12 months

    Measured by self-report questionnaire

  3. Diabetes-related distress

    Time frame: Change from baseline at 12 months

    Measured by self-report questionnaire

  4. Depressive symptoms

    Time frame: Change from baseline at 12 months

    Measured by self-report questionnaire

  5. Blood pressure

    Time frame: Baseline and 12 months

    Obtained from electronic medical record.

  6. Cholesterol

    Time frame: Baseline and 12 months

    Obtained from electronic medical record.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • New York City Department of Health and Mental Hygiene

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 14, 2014
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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