My Diabetes, My Community

The University of Chicago

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: My Diabetes Goal + CommunityRx; Behavioral: My Diabetes Goal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04970810

IRB20-0870

1R01DK127961-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 512 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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512 participants in 3 patient groups

Attention Control

No Intervention group

Description:

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

My Diabetes Goal

Active Comparator group

Description:

My Diabetes Goal protocol

Treatment:

Behavioral: My Diabetes Goal

My Diabetes Goal + Community Rx

Active Comparator group

Description:

My Diabetes Goal protocol + Community Rx protocol

Treatment:

Behavioral: My Diabetes Goal + CommunityRx