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My Diabetes, My Community

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Diabetes Goal
My Diabetes Goal + CommunityRx
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of type 2 diabetes
  2. Seen in clinic within past year
  3. A1C>7.5%
  4. Community dwelling
  5. Access to personal email address OR internet access
  6. Speaks and reads English
  7. Resides in the target geographic region (zip codes)

Exclusion Criteria:

  1. Unable to consent to study for themselves
  2. Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials

Sites / Locations

  • University of Chicago Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Attention Control

My Diabetes Goal

My Diabetes Goal + Community Rx

Arm Description

Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)

My Diabetes Goal protocol

My Diabetes Goal protocol + Community Rx protocol

Outcomes

Primary Outcome Measures

A1c
Change in A1c

Secondary Outcome Measures

Assessment of personalized diabetes care goal
Investigators will compare diabetes care goals documented in the EHR against the study survey. The possible values will be yes or no goals documented in the EHR.
Patients' ability to reach personalized goals
Investigators will measure whether or not patients are reaching the goals they have documented in the survey, among those who have set up their personalized goals. The possible values will be yes or no reaching personalized goals.
Diabetes Self-Efficacy
Evaluate subject self-efficacy through the diabetes empowerment scale.

Full Information

First Posted
May 18, 2020
Last Updated
September 15, 2023
Sponsor
University of Chicago
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04970810
Brief Title
My Diabetes, My Community
Official Title
My Diabetes, My Community
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 29, 2021 (Actual)
Primary Completion Date
July 28, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. Investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. This highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.
Detailed Description
To address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. The American Geriatrics Society (AGS) and the American Diabetes Association (ADA) have published recommendations urging individualized glycemic goals (hemoglobin A1C (A1C) <7.5%, <8.0%, or <8.5%) for three strata of older patients (healthy, complex, very complex). The guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. Despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. Interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources. Investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. Managing Diabetes to Gain Opportunities for a More Active Life (My Diabetes GOAL) and CommunityRx. The My Diabetes GOAL intervention is designed to engage older patients in personalized goal setting and chronic disease management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
This will be a single-blind study, and subjects will blinded to the different group assignment.
Allocation
Randomized
Enrollment
505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
Arm Title
My Diabetes Goal
Arm Type
Active Comparator
Arm Description
My Diabetes Goal protocol
Arm Title
My Diabetes Goal + Community Rx
Arm Type
Active Comparator
Arm Description
My Diabetes Goal protocol + Community Rx protocol
Intervention Type
Behavioral
Intervention Name(s)
My Diabetes Goal
Intervention Description
Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
Intervention Type
Behavioral
Intervention Name(s)
My Diabetes Goal + CommunityRx
Intervention Description
Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource "prescriptions") for community organizations.
Primary Outcome Measure Information:
Title
A1c
Description
Change in A1c
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Assessment of personalized diabetes care goal
Description
Investigators will compare diabetes care goals documented in the EHR against the study survey. The possible values will be yes or no goals documented in the EHR.
Time Frame
Baseline to 12 months
Title
Patients' ability to reach personalized goals
Description
Investigators will measure whether or not patients are reaching the goals they have documented in the survey, among those who have set up their personalized goals. The possible values will be yes or no reaching personalized goals.
Time Frame
Baseline to 12 months
Title
Diabetes Self-Efficacy
Description
Evaluate subject self-efficacy through the diabetes empowerment scale.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of type 2 diabetes Seen in clinic within past year A1C>7.5% Community dwelling Access to personal email address OR internet access Speaks and reads English Resides in the target geographic region (zip codes) Exclusion Criteria: Unable to consent to study for themselves Prior participation in CRxCaregiver, CRxHunger, or My Diabetes GOAL trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elbert Huang
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stacy Lindau
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD with other researchers.

Learn more about this trial

My Diabetes, My Community

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