My Diabetes, My Community

Study Overview
=================
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.

Official Title
-----------------
My Diabetes, My Community

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: My Diabetes Goal
* Behavioral: My Diabetes Goal + CommunityRx


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1c | Change in A1c | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 12 months | 
| 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. | Baseline to 12 months | 
| Diabetes Self-Efficacy | Evaluate subject self-efficacy through the diabetes empowerment scale. | Baseline to 12 months |