Clinical trial NCT02137720: Translating Telephonic Diabetes Self-management Support to Primary Care Practice
Official title: Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Treatment Adherence
Self-management
Emotional Distress
Diabetes-related Distress
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: New York City Department of Health and Mental Hygiene
First posted: 2014-05-14
Enrollment: 812
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: HbA1c
timeFrame: Change from baseline at 12 months
Secondary outcomes:
measure: Diabetes Self-Management
timeFrame: Change from baseline at 12 months
measure: Medication Adherence
timeFrame: Change from baseline at 12 months
measure: Diabetes-related distress
timeFrame: Change from baseline at 12 months
measure: Depressive symptoms
timeFrame: Change from baseline at 12 months
measure: Blood pressure
timeFrame: Baseline and 12 months
measure: Cholesterol
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York City Department of Health and Mental Hygiene
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Jeffrey S Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York City Department of Health and Mental Hygiene
name: Winfred Y Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez JS, Hoogendoorn CJ, Linnell J, Fishman S, Jonas V, Pham-Singer H, Schechter CB, Walker EA, Wu WY. Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support. Contemp Clin Trials. 2020 Nov;98:106166. doi: 10.1016/j.cct.2020.106166. Epub 2020 Oct 3.