Diabetes Outcomes and Unmet Resources

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Guest Assistance Program; Behavioral: CareAvenue

• Registration Number: NCT03950973
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2019-06-26
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Results First Submitted: 2024-03-03
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Results First Posted: 2024-05-02
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guest Assistance Program	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.
CareAvenue	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c as Measured by an HbA1c Machine	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
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)	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.
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)	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.
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)	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.
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)	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.
Change in Unmet Social Risk Factors as Measured by Participant Questionnaire	Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States