Diabetes Outcomes and Unmet Resources

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950973
• Other study ID #: HUM00149794
• Secondary ID: R01DK116715
• Status: Completed
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: March 28, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)