Study Results
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View full resultsBasic Information
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COMPLETED
NA
667 participants
INTERVENTIONAL
2019-06-26
2023-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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CareAvenue
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.
CareAvenue
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.
Guest Assistance Program
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.
Guest Assistance Program
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.
Interventions
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CareAvenue
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.
Guest Assistance Program
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Michigan
OTHER
Responsible Party
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Minal Patel
Associate Professor
Principal Investigators
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Minal R Patel, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Patel MR, Zhang G, Heisler M, Piette JD, Resnicow K, Choe HM, Shi X, Song P. A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes. J Gen Intern Med. 2024 Oct;39(13):2415-2424. doi: 10.1007/s11606-024-08708-8. Epub 2024 Mar 11.
Patel MR, Heisler M, Piette JD, Resnicow K, Song PXK, Choe HM, Shi X, Tobi J, Smith A. Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes- A randomized controlled trial. Contemp Clin Trials. 2020 Feb;89:105933. doi: 10.1016/j.cct.2020.105933. Epub 2020 Jan 7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00149794
Identifier Type: -
Identifier Source: org_study_id
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