Diabetes Outcomes and Unmet Resources

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: CareAvenue; Behavioral: Guest Assistance Program

• Study Type: Interventional
• Enrollment (Actual): 667
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine	Systolic blood pressure will be measured at baseline, 6 months, and 12 months using an automated blood pressure machine in millimeters of mercury (e.g., 120 mm Hg). The change in systolic blood pressure from baseline to 12 months is reported here as secondary outcome.	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	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. Min value of 0, max value of 18, with higher scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome.	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	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. Mean values were obtained, with min value of 0, max value of 1, with higher mean scores indicating more cost-related non-adherence behaviors. The change in CRN behaviors from baseline to 12 months is reported here as the secondary outcome.	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)	Perceived Financial Burden will be measured at baseline, 6 months, and 12 months by the 11-item measure Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) that were measured on a 5-point scale (0: not at all - 4: very much). The score includes reverse-coding 6-items, summing all items, multiplying sum by 11 and dividing the total by number of items answered. Lower scores indicate higher perceptions of financial burden. (Min value of 0, max value of 44) The change in perceived financial burden (COST measure) from baseline to 12 months is reported here as secondary outcome.	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	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). Higher number of "yes" responses indicates higher number of unmet social risk factors/higher need. (Min value of 0, max value of 20). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome.	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
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. Higher scores indicate more unmet social risk factors (min value of 0; max value of 8). The change in unmet social risk factors from baseline to 12 months is reported here as secondary outcome.	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Minal R Patel, PhD, MPH, University of Michigan

Publications and helpful links

General Publications

• 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. Erratum In: Contemp Clin Trials. 2020 May 14;:106025.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Adherence; Self-management; Social determinants of health; Social risk factors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HUM00149794; R01DK116715 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data that underlie results in a publication, after de-identification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No