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Translating Telephonic Diabetes Self-management Support to Primary Care Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137720
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : July 27, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Jeffrey Gonzalez, Albert Einstein College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Telephonic Diabetes Self-Management Support Other: Educational Print Materials Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 812 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial
Actual Study Start Date : June 2014
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: Change from baseline at 12 months ]
    Obtained from electronic medical record.


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137720


Locations
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United States, New York
New York City Department of Health and Mental Hygiene
New York, New York, United States, 11101
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New York City Department of Health and Mental Hygiene
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeffrey Gonzalez, Associate Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02137720    
Other Study ID Numbers: 2012-422
1R18DK098742-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Keywords provided by Jeffrey Gonzalez, Albert Einstein College of Medicine:
Diabetes
Treatment Adherence
Self-management
Emotional Distress
Diabetes-related Distress
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases