Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619834
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Financial Navigation and Peer Support to Improve Diabetes Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Trial of Financial Navigation and Peer Support to Improve Diabetes Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FNaPS
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 participantsampamp39 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None