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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
667
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.
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.
University of Michigan
Ann Arbor, Michigan, United States
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.
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)