Translating Telephonic Diabetes Self-management Support to Primary Care Practice
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|ClinicalTrials.gov Identifier: NCT02137720|
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : July 27, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Telephonic Diabetes Self-Management Support Other: Educational Print Materials||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||812 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- HbA1c [ Time Frame: Change from baseline at 12 months ]Obtained from electronic medical record.
- Diabetes Self-Management [ Time Frame: Change from baseline at 12 months ]Measured by self-report questionnaire
- Medication Adherence [ Time Frame: Change from baseline at 12 months ]Measured by self-report questionnaire
- Diabetes-related distress [ Time Frame: Change from baseline at 12 months ]Measured by self-report questionnaire
- Depressive symptoms [ Time Frame: Change from baseline at 12 months ]Measured by self-report questionnaire
- Blood pressure [ Time Frame: Baseline and 12 months ]Obtained from electronic medical record.
- Cholesterol [ Time Frame: Baseline and 12 months ]Obtained from electronic medical record.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|United States, New York|
|New York City Department of Health and Mental Hygiene|
|New York, New York, United States, 11101|
|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|
|Responsible Party:||Jeffrey Gonzalez, Associate Professor, Albert Einstein College of Medicine|
|Other Study ID Numbers:||
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|
Glucose Metabolism Disorders
Endocrine System Diseases