Clinical trial NCT06619834: Financial Navigation and Peer Support to Improve Diabetes Outcomes
Official title: Pilot Trial of Financial Navigation and Peer Support to Improve Diabetes Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 56
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: OTHER

Brief summary: The goal of this clinical trial pilot study is to test the feasibility, acceptability, and preliminary efficacy of a combined intervention strategy of 1) technology-supported financial navigation to address economic burden of disease and 2) peer support both to facilitate linkages to clinical care and community resources to address social risks and improve participants\&amp;amp;#39; diabetes self-management. The main aims of this pilot study are:

* To examine the feasibility and acceptability of technology-supported financial navigation and financial navigation with peer support
* To examine trends in preliminary efficacy of technology-supported financial navigation and peer support versus financial navigation-alone on 1) A1c and blood pressure (primary outcomes), and 2) out-of-pocket costs, treatment-related financial stress, cost-related non-adherence behaviors, diabetes distress, diabetes self-care behaviors, and uptake of social care assistance (secondary outcomes).

The investigators will assess whether a combined intervention of technology-supported financial navigation and peer support will produce trends in superior diabetes and social care outcomes to financial navigation alone via a 2-arm randomized controlled trial.

Participants will

* Complete 3 survey appointments at baseline, and 3 and 6 months. Each appointment will consist of a survey assessment, an HbA1C test, and two blood pressure readings over the phone.
* Be randomized to either financial navigation only or financial navigation and peer support.


Eligibility criteria: Inclusion Criteria:

Participants:

* 18-75 years of age
* diagnosis of diabetes with prescribed anti-hyperglycemic medication
* most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of ≥7.5% for individuals ≤70 years and \&amp;amp;gt;8.0% for individuals between 70-75 years in age
* positive report of financial burden or cost-related non-adherence (CRN) using screening questions developed and validated from prior work 20-22
* be willing to provide personal health information in order to effectively participate in the intervention

Peer Supporters:

* International Classification of Diseases (ICD)-10 code for diabetes
* In the past had A1cs\&amp;#39; \&amp;gt; 8.0% but whose most recent A1c in the prior 12 months is \&amp;lt;8.0%.
* Past experience with economic burden or unmet social risk factors
* Adults 18-75 years

Exclusion Criteria:

Participants:

* a diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
* active alcohol or illicit drug use
* current pregnancy or planning pregnancy
* taking a medication that alters glucose metabolism (e.g., oral steroids)
* report a comorbidity expected to limit life span to \&amp;amp;lt; 3 years
* Participation in another diabetes study, but the investigators will ask them if they would like to be peer supporters

Peer Supporters:

* A diagnosis of a serious psychiatric disorder (e.g., schizophrenia)
* Active alcohol or illicit drug use
* Current pregnancy or planning pregnancy

Primary outcomes:
measure: A1c
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Blood Pressure
timeFrame: From enrollment to the end of participant study duration at 6 months
Secondary outcomes:
measure: Uptake of social care assistance
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Successfully having social/financial need address
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Cost-related non-adherence behaviors
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Out-of-pocket costs
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Diabetes-related social support
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Diabetes self-care behaviors
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Social needs screening
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Diabetes Distress
timeFrame: From enrollment to the end of participant study duration at 6 months
measure: Treatment-related financial stress
timeFrame: From enrollment to the end of participant study duration at 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: