Diabetes Outcomes and Unmet Resources

Study Overview
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Brief Summary
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This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.

Official Title
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Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: CareAvenue
* Behavioral: Guest Assistance Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18-75 years of age Be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication Have a most recent hemoglobin A1c(HbA1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and >8.0% for individuals between 70-75 years in age Have access to a telephone that can receive and send text messages Not participating in another diabetes intervention research study Exclusion Criteria: Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CareAvenue<br>Participants receive access to CareAvenue, an e-health tool, and receive one weekly automated telephone call and 4-5 text messages per week for 52 weeks. | Behavioral: CareAvenue<br>* CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.<br>|
| Active Comparator: Guest Assistance Program<br>Participants receive information about the Guest Assistance Program (GAP) and receive 3-4 text messages per week related to diabetes management and resources for 52 weeks. | Behavioral: Guest Assistance Program<br>* The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c as measured by an HbA1c machine | Change in HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage. | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure as measured an automated blood pressure machine | Change in blood pressure will be measured at baseline, 6 months, and 12 months using an automated blood pressure machine. Blood pressure is measured as systolic blood pressure/diastolic blood pressure in millimeters of mercury (e.g., 120/80 mm Hg). | Baseline, 6 months, 12 months | 
| Change in Cost-Related Non-Adherence Behaviors with prescribed treatment regimens related to diabetes as measured by participant questionnaire | Cost-Related Non-Adherence (CRN) Behaviors related to diabetes will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at diabetes. The items are measured with a 4-point Likert scale. Participants answering often or sometimes to any of the items are indicated as exhibiting CRN. | Baseline, 6 months, 12 months | 
| Change in Cost-Related Non-Adherence Behaviors with prescribed treatment regimens related to other conditions being managed as measured by participant questionnaire | Cost-Related Non-Adherence (CRN) Behaviors related to other conditions being managed will be measured at baseline, 6 months, and 12 months by 4-items adapted from the Medicare Current Beneficiary Survey and 2 items adapted from the National Health Interview Survey that look at other health conditions being managed. The items are measured with a 4-point Likert scale. Participants answering often or sometimes to any of the items are indicated as exhibiting CRN. | Baseline, 6 months, 12 months | 
| Change in Perceived Financial Burden as measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) | Perceived Financial Burden will be measured at baseline, 6 months, and 12 months by the 12-item measure Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT). The items are measured with a 5-point Likert scale. The higher the score the better the Financial well-being. | Baseline, 6 months, 12 months | 
| Change in Unmet Social Risk Factors as measured by participant questionnaire | Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 20 items adapted from the Accountable Health Communities Health-Related Social Needs Screening Tool, the Health Leads Social Needs Screening Toolkit, and the Kaiser Permanente Your Current Life Situation Questionnaire. The item values are binary (yes/no). Number of yes responses indicates number of unmet social risk factors. | Baseline, 6 months, 12 months | 
| Change in Unmet Social Risk Factors as measured by participant questionnaire | Change in Unmet Social Risk Factors will be measured at baseline, 6 months, and 12 months by 3 items from the Accountable Health Communities Health-Related Social Needs Screening Tool and 1 item adapted from the National Health Interview Survey. The items each have three response options, in which a positive response indicates an unmet social risk factor. | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Self-management, Adherence, Social determinants of health, Social risk factors