Diabetes Outcomes and Unmet Resources

University of Michigan

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Guest Assistance Program; Behavioral: CareAvenue

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03950973

HUM00149794

R01DK116715 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 667 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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667 participants in 2 patient groups

CareAvenue

Experimental group

Description:

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.

Treatment:

Behavioral: CareAvenue

Guest Assistance Program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Guest Assistance Program