Diabetes Outcomes and Unmet Resources

NCT03950973 | Completed Results DMC

• 2 other identifiers: HUM00149794R01DK116715
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Keywords

Diabetes; Self-management; Adherence; Social determinants of health; Social risk factors

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c as Measured by an HbA1c Machine

  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. The change in HbA1c from baseline to 12 months is reported here as the primary outcome.

  Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)

Secondary Outcomes (6)

• Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine

  Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)

• Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire

  Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)

• Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire

  Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)

• Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)

  Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)

• Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire

  Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)

Study Arms (2)

CareAvenue

EXPERIMENTAL

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

Guest Assistance Program

ACTIVE COMPARATOR

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

Interventions

CareAvenue BEHAVIORAL

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.

CareAvenue

Guest Assistance Program BEHAVIORAL

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.

Guest Assistance Program

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• 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.

  PMID: 38467918 DERIVED

• 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.

  PMID: 31923472 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Minal R. Patel, Ph.D, M.P.H
• Organization: University of Michigan School of Public Health, Department of Health Behavior & Health Education

minalrp@umch.edu

(734) 763-0087

Study Officials

• Minal R Patel, PhD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: June 26, 2019
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: The data will be made available to other researchers who provide a methodologically sound proposal and who have appropriate approvals from all relevant IRBs. The data will be shared for analyses to achieve aims in the approved proposal. Data will be shared through a secure FTP site through encryption protocols that allow secure uploading of files with data sharing limited to specific users. Select datasets will also be made available through the University of Michigan openICPSR Repository (http://www.icpsr.umich.edu/icpsrweb/deposit/index.jsp). Proposals should be directed to minalrp@umich.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)