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My Diabetes, My Community

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: NCT04970810
Recruitment Status : Active, not recruiting
First Posted : July 21, 2021
Last Update Posted : September 18, 2023
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: My Diabetes Goal Behavioral: My Diabetes Goal + CommunityRx Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: This will be a single-blind study, and subjects will blinded to the different group assignment.
Primary Purpose: Supportive Care
Official Title: My Diabetes, My Community
Actual Study Start Date : July 29, 2021
Estimated Primary Completion Date : July 28, 2024
Estimated Study Completion Date : July 28, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Attention Control
Subjects monthly calls similar in structure to the intervention arms, but without support. (attention placebo control)
Active Comparator: My Diabetes Goal
My Diabetes Goal protocol
 Behavioral: My Diabetes Goal
Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
Active Comparator: My Diabetes Goal + Community Rx
My Diabetes Goal protocol + Community Rx protocol
 Behavioral: My Diabetes Goal + CommunityRx
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.


Outcome Measures
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Primary Outcome Measures :
  1. A1c [ Time Frame: Baseline to 12 months ]
    Change in A1c


Secondary Outcome Measures :
  1. Assessment of personalized diabetes care goal [ Time Frame: Baseline to 12 months ]
    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.

  2. Patients' ability to reach personalized goals [ Time Frame: Baseline to 12 months ]
    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.

  3. Diabetes Self-Efficacy [ Time Frame: Baseline to 12 months ]
    Evaluate subject self-efficacy through the diabetes empowerment scale.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT04970810


Locations
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United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Elbert Huang University of Chicago
Principal Investigator: Stacy Lindau University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Study Protocol and Statistical Analysis Plan  [PDF] June 23, 2021

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04970810    
Other Study ID Numbers: IRB20-0870
1R01DK127961-01 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases