Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases
Conditions
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' 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.
Interventions
BEHAVIORALFinancial Navigation and Peer Support
A combined intervention of technology-supported financial navigation and peer support: A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks. Participants will also be matched with a Peer Supporter to help improve the participants\' diabetes self-management.
BEHAVIORALFinancial Navigation Only
A professional financial navigator from TailorMed will use the software to assist participants in exploring options to reduce their specific economic barriers to treatment and care, and non-medical social risks.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 \>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\' \> 8.0% but whose most recent A1c in the prior 12 months is \<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 \< 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1c | From enrollment to the end of participant study duration at 6 months | Collect A1c sample using A1c Now SelfCheck test kit |
| Blood Pressure | From enrollment to the end of participant study duration at 6 months | Measure participant blood pressure using the Omron home blood pressure monitor. Both systolic and diastolic blood pressure will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of social care assistance | From enrollment to the end of participant study duration at 6 months | Adapted from Your Current Life Situation (YCLS) and Health Leads Screening Tools |
| Successfully having social/financial need address | From enrollment to the end of participant study duration at 6 months | Enrollment data from TailorMed software |
| Cost-related non-adherence behaviors | From enrollment to the end of participant study duration at 6 months | Individual survey items adapted from National Health Interview Survey (NHIS) |
| Out-of-pocket costs | From enrollment to the end of participant study duration at 6 months | Data generated from TailorMed software |
| Diabetes-related social support | From enrollment to the end of participant study duration at 6 months | Diabetes Support Scale (DSS) Minimum value- Strongly Disagree, Maximum value- Strongly Agree Higher score mean a better outcome. |
| Diabetes self-care behaviors | From enrollment to the end of participant study duration at 6 months | Diabetes Self-care Activities Scale - Adapted Minimum value- 0 Days, Maximum value- 7 Days Higher scores mean a better outcome. |
| Social needs screening | From enrollment to the end of participant study duration at 6 months | Accountable Health Communities Health-Related Social Needs Screening Tool (Q15-17) and Item adapted from National Health Interview Survey (Q18) Adapted from Accountable Health Communities Health-Related Social Needs Screening Tool, Health Leads Social Needs Screening Toolkit, \& Kaiser Permanente Your Current Life Situation Questionnaire Minimum value- Never True, Maximum value- Often True. Higher scores mean worse outcome. |
| Diabetes Distress | From enrollment to the end of participant study duration at 6 months | Diabetes Distress Scale (DDS2 version) Minimum Value- Not a Problem, Maximum Value- Serious Problem Higher scores mean worse outcome. |
| Treatment-related financial stress | From enrollment to the end of participant study duration at 6 months | COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) domains adapted for diabetes 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) |
Countries
United States
Outcome results
None listed