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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04970810|
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : August 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: My Diabetes Goal Behavioral: My Diabetes Goal + CommunityRx||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||612 participants|
|Intervention Model:||Parallel Assignment|
|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 :||May 31, 2024|
|Estimated Study Completion Date :||June 30, 2024|
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.
- A1c [ Time Frame: Baseline to 12 months ]Change in A1c
- 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.
- 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.
- Diabetes Self-Efficacy [ Time Frame: Baseline to 12 months ]Evaluate subject self-efficacy through the diabetes empowerment scale.
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
|Contact: Aviva Nathanfirstname.lastname@example.org|
|Contact: Elbert Huang|
|United States, Illinois|
|University of Chicago Medicine||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Aviva Nathan 773-702-9521|
|Principal Investigator:||Elbert Huang||University of Chicago|
|Principal Investigator:||Stacy Lindau||University of Chicago|