Clinical trial NCT03950973: Diabetes Outcomes and Unmet Resources
Official title: Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Self-management
Adherence
Social determinants of health
Social risk factors
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-05-15
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c as Measured by an HbA1c Machine
timeFrame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Secondary outcomes:
measure: Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine
timeFrame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
measure: Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire
timeFrame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
measure: Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire
timeFrame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
measure: Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)
timeFrame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
measure: Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire
timeFrame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
measure: Change in Unmet Social Risk Factors as Measured by Participant Questionnaire
timeFrame: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Minal R Patel, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.