Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07676188
Status
Not Yet Recruiting

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Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FindHelp — BEHAVIORAL
    All study participants will be assigned to engage FindHelp (www.FindHelp.org), either as a stand-alone intervention (usual care) or in combination with Peer Support and/or second-stage interventions, as applicable. FindHelp is a free website/app that connects people to local resources.
  • Peer Support — BEHAVIORAL
    Some participants will be assigned to receive the peer support intervention, which will involve pairing participants with a peer supporter whose experience with diabetes management may help them better manage their own condition. Peer supporters will be matched with participants based on shared demographic characteristics, diabetes type, and language. Peer supporters will be trained in key peer support skills, including motivational interviewing, to help participants explore and work toward their goals.
  • Social Work — BEHAVIORAL
    Participants will be referred to social workers within our health system, specifically with the Guest Assistance Program through Michigan Medicine. GAP connects patients with social workers knowledgeable about community and University of Michigan resources to work with them and problem-solve concerns affecting their health.
  • Financial Navigation — BEHAVIORAL
    Participants will connect with the Patient Advocate Foundation's Case Management Program. PAF Case Management is a national program that provides free one-on-one support to eligible patients dealing with challenges related to a chronic health condition. Their case managers help people work through real-life issues, including access to medical treatment, understanding health insurance coverage, and applying for programs that may help with living expenses.

Study Details

Unmet social needs and economic burden persist as key reasons why one-third of people with diabetes have poor disease control. The purpose of this study is to learn whether different tools and types of support may help people manage diabetes and related challenges. The study will compare several approaches to understand how they affect people's experiences and health over time. Completion of our study aims will lead to an optimized intervention to improve the health and social well-being of people with diabetes. Participants will be randomly assigned to one or more interventions aimed at addressing social and financial needs and will complete multiple surveys over the course of a year. The study team will collect information about your blood pressure and HbA1c (blood glucose). Findings will advance the field by determining the effectiveness of supportive interventions to address both social needs and diabetes self-care, and by informing protocols for the optimal sequencing of these strategies, a critical evidence gap in healthcare settings.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
694 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: FindHelp
  • Experimental: FindHelp with Social Worker
  • Experimental: FindHelp with Financial Navigation
  • Experimental: FindHelp + Peer Support
  • Experimental: FindHelp + Peer Support with Social Worker
  • Experimental: FindHelp + Peer Support w/ Financial Navigation
  • Other: Peer Supporters
    Up to 100 peer supporters will be recruited, matched, and provide ongoing support to 1-4 study participants.

Primary Outcome Measure

HbA1c [ Time Frame: Labs will be drawn at 4 assessment points: At baseline, 3-months, 6-months, and 12-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Minal R Patel
[email protected]
734-763-0087

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By research site
University of Michigan· Ann Arbor, MI

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