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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial Navigation only | Active Comparator | Financial navigation using software called TailorMed only. The professional Financial Navigator is from the TailorMed team. |
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| Financial Navigation and Peer Support | Active Comparator | Financial navigation using software called TailorMed combined with peer support. The professional Financial Navigator is from the TailorMed team. Peer Supporters will be trained community members recruited from Michigan Medicine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Navigation and Peer Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| A1c | Collect A1c sample using A1c Now SelfCheck test kit | From enrollment to the end of participant study duration at 6 months |
| Blood Pressure | Measure participant blood pressure using the Omron home blood pressure monitor. Both systolic and diastolic blood pressure will be measured. | From enrollment to the end of participant study duration at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of social care assistance | Adapted from Your Current Life Situation (YCLS) and Health Leads Screening Tools | From enrollment to the end of participant study duration at 6 months |
| Successfully having social/financial need address |
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Inclusion Criteria:
Participants:
Peer Supporters:
Exclusion Criteria:
Participants:
Peer Supporters:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
All of the individual participant data that underlie results in a publication, after de-identification.
Beginning 3 months and ending 5 years following article publication
The data will be made available to other researchers who provide a methodologically sound proposal and who have appropriate approvals from all relevant Institutional Review Boards (IRBs). The data will be shared for analyses to achieve aims in the approved proposal. Data will be shared through a secure File Transfer Protocol (FTP) site through encryption protocols that allow secure uploading of files with data sharing limited to specific users. Select datasets will also be made available through the University of Michigan openICPSR Repository (http://www.icpsr.umich.edu/icpsrweb/deposit/index.jsp). Proposals should be directed to minalrp@umich.edu. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| Financial Navigation Only | Behavioral | 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. |
|
Enrollment data from TailorMed software
| From enrollment to the end of participant study duration at 6 months |
| Cost-related non-adherence behaviors | Individual survey items adapted from National Health Interview Survey (NHIS) | From enrollment to the end of participant study duration at 6 months |
| Out-of-pocket costs | Data generated from TailorMed software | From enrollment to the end of participant study duration at 6 months |
| Diabetes-related social support | Diabetes Support Scale (DSS) Minimum value- Strongly Disagree, Maximum value- Strongly Agree Higher score mean a better outcome. | From enrollment to the end of participant study duration at 6 months |
| Diabetes self-care behaviors | Diabetes Self-care Activities Scale - Adapted Minimum value- 0 Days, Maximum value- 7 Days Higher scores mean a better outcome. | From enrollment to the end of participant study duration at 6 months |
| Social needs screening | 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. | From enrollment to the end of participant study duration at 6 months |
| Diabetes Distress | Diabetes Distress Scale (DDS2 version) Minimum Value- Not a Problem, Maximum Value- Serious Problem Higher scores mean worse outcome. | From enrollment to the end of participant study duration at 6 months |
| Treatment-related financial stress | 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) | From enrollment to the end of participant study duration at 6 months |