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.
Brief Title
Translating Telephonic Diabetes Self-management Support to Primary Care Practice
Completion Date
Completion Date Type
Actual
Conditions
Type 2 Diabetes
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Diabetes
Treatment Adherence
Self-management
Emotional Distress
Diabetes-related Distress
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT02137720
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2012-422
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Translating Telephonic Diabetes Self-management Support to Primary Care Practice: The NYC Care Calls Trial
Primary Outcomes
Outcome Description
Obtained from electronic medical record.
Outcome Measure
HbA1c
Outcome Time Frame
Change from baseline at 12 months
Secondary Ids
Secondary Id
1R18DK098742-01A1
Secondary Outcomes
Outcome Description
Measured by self-report questionnaire
Outcome Time Frame
Change from baseline at 12 months
Outcome Measure
Diabetes Self-Management
Outcome Description
Measured by self-report questionnaire
Outcome Time Frame
Change from baseline at 12 months
Outcome Measure
Medication Adherence
Outcome Description
Measured by self-report questionnaire
Outcome Time Frame
Change from baseline at 12 months
Outcome Measure
Diabetes-related distress
Outcome Description
Measured by self-report questionnaire
Outcome Time Frame
Change from baseline at 12 months
Outcome Measure
Depressive symptoms
Outcome Description
Obtained from electronic medical record.
Outcome Time Frame
Baseline and 12 months
Outcome Measure
Blood pressure
Outcome Description
Obtained from electronic medical record.
Outcome Time Frame
Baseline and 12 months
Outcome Measure
Cholesterol
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jeffrey Gonzalez
Investigator Email
jeffrey.gonzalez@einsteinmed.org
Investigator Phone