Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD) (LINKD)

Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial

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 the 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 their 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: FindHelp; Behavioral: Social Work; Behavioral: Financial Navigation; Behavioral: Peer Support

Detailed Description

Multiple adverse social risks (e.g. food and/or housing insecurity, transportation challenges, social isolation) and out-of-pocket, disease-related expenses are key reasons 1/3 of people with diabetes have high A1cs. Through the CareAvenue mHealth intervention (R01DK116715), the investigators enhanced the original intervention of screening for social risks and connecting people with diabetes to resources by adding features for observational learning, autonomy support, action planning, and self-monitoring. The investigators observed low engagement with the intervention and effectiveness for only 5% of participants. Social support interventions (e.g. peer support, financial navigators, social workers) are more effective in addressing unmet social needs and self- care challenges than stand-alone technology tools. However, these strategies are more resource- and labor- intensive. Rather than dispensing the same fixed package of treatment components to all patients, an adaptive approach can conserve resources by initiating autonomy-supportive treatment, and stepping up treatments for those with suboptimal uptake. This R01 builds on the productivity, infrastructure, and investment of their prior work to address key knowledge gaps for uptake of social care assistance to improve disease outcomes.

The overarching goal of this study is to identify what type of supportive components are optimal for addressing unmet social needs and diabetes self-care, and which of five adaptive sequences of treatment results in better outcomes. The investigators will recruit 594 people with diabetes who have high A1cs, unmet social needs, and want assistance with their needs. They will use a Sequential Multiple Assignment Randomized Trial (SMART) design with 12-month follow-up to conduct this research. In Aim 1, they will determine which of five adaptive intervention sequences is optimal for reducing A1c compared to social needs app only (usual care): 1) App + peer support; 2) App + social worker; 3) App + technology-supported financial navigation; 4) App + peer support + social worker; 5) App + peer support + technology-supported financial navigation. In Aim 2, they will determine which of two augmented treatment adaptations is optimal for reducing A1c among non-responders: social worker or technology-supported financial navigation. In exploratory Aim 2A, they will identify patient-level moderators of treatment effect to inform personalized, resource-efficient protocols. In Aim 3, they will estimate the cost-effectiveness of five adaptive intervention sequences.

The result of this SMART study will be an optimized, adaptive intervention to improve the health and social well-being of people with diabetes by determining the most effective intervention strategies.

• Study Type: Interventional
• Enrollment (Estimated): 694
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minal R Patel; Phone Number: 734-763-0087; Email: minalrp@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
      • Contact: Minal R Patel; Phone Number: 734-763-0087; Email: minalrp@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants:

• Age: 18 years of age or older
• Diabetes diagnosis: Documented diagnosis of diabetes (Type 1 or Type 2) with prescribed anti-hyperglycemic medication
• Glycemic control: Most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.0% for individuals between 70-75 years of age Prior study participation: Did not participate in the CareAvenue trial (R01DK116715)
• Financial burden and/or social needs (meeting ONE or more of the following):

Positive report of financial burden using validated screening questions; Medicaid or dual Medicare/Medicaid coverage; Income ≤250% of the federal poverty level; Self-identified as ALICE (Asset-Limited, Income-Constrained, Employed): income above Medicaid threshold but reporting difficulty affording basic needs; Underinsured: high-deductible plan (≥$1,500 individual/$3,000 family) with self-reported difficulty affording healthcare costs; Positive screen for one or more social risk factors on PRAPARE or equivalent (food insecurity, housing instability, transportation barriers, utility insecurity);

• Financial decision-making: Self-identifies as primarily responsible for making own healthcare financial decisions (to address concerns about young adults dependent on family support).
• Interest in assistance: Expresses interest in receiving assistance with unmet social needs.
• Ability to participate: Able to complete the screening process in English (or Spanish/Arabic if materials available) on behalf of self.
• Healthcare access: Receives or is able to receive care at Michigan Medicine (required for potential social worker referral).

Peer Supporters:

• Age: 18 years of age or older
• Diabetes diagnosis: Self-reported diagnosis of diabetes (Type 1 or Type 2)
• Glycemic control: Within the past 12 months, have had at least one hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.5% for individuals ≥71 years of age, but have since had at least one A1c (HbA1c) level, including their most recent test, of: <7.5% for individuals ≤70 years of age and <8.5% for individuals ≥71 years of age
• Experience navigating social or financial resources: Self-reported success in navigating financial assistance or social services resources
• Ability to participate: Able to provide peer support in English (option to additionally provide support in Spanish and/or Arabic); Able to complete training; Able to make calls every other week with assigned participants; Able to submit call logs; Able to complete a brief survey about experience throughout participation.
• Confidence in diabetes self-management: Self-reported confidence in ability to manage diabetes

Exclusion Criteria:

Participants:

• Serious psychiatric disorder: Active diagnosis of schizophrenia, active psychosis, or other serious mental illness that would impair ability to engage in intervention (as determined by medical record review)
• Cognitive impairment: Documented moderate to severe cognitive impairment that would prevent meaningful participation in study activities (as determined by medical record review)
• Active substance use: Current active illicit drug use that would interfere with study participation (as determined by medical record review)
• Pregnancy: Currently pregnant or planning pregnancy during the study period (due to expected A1c changes) (as determined by medical record review)
• Glucose-altering medications: Currently taking medications that alter glucose metabolism as a side effect rather than for diabetes management, including: Chronic oral corticosteroids (≥2 weeks continuous use); Antipsychotic medications known to affect glucose; Other medications affecting glucose when NOT prescribed for diabetes management Note: GLP-1 agonists, SGLT2 inhibitors, and other diabetes medications are NOT excluded, regardless of whether they are also used for weight management
• Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years
• Concurrent diabetes study participation: Currently enrolled in another diabetes intervention study
• Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own behalf

Peer Supporters:

• Cognitive impairment: Self-reported cognitive impairment that would prevent meaningful participation in study activities
• Participation Concerns or Barriers: Self-reported concerns that would prevent meaningful participation in study activities
• Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years
• Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FindHelp	Behavioral: FindHelp; 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.
Experimental: FindHelp with Social Worker	Behavioral: FindHelp; 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.; Behavioral: Social Work; 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.
Experimental: FindHelp with Financial Navigation	Behavioral: FindHelp; 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.; Behavioral: Financial Navigation; 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.
Experimental: FindHelp + Peer Support	Behavioral: FindHelp; 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.; Behavioral: Peer Support; 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.
Experimental: FindHelp + Peer Support with Social Worker	Behavioral: FindHelp; 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.; Behavioral: Social Work; 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.; Behavioral: Peer Support; 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.
Experimental: FindHelp + Peer Support w/ Financial Navigation	Behavioral: FindHelp; 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.; Behavioral: Financial Navigation; 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.; Behavioral: Peer Support; 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.
Other: Peer Supporters; Up to 100 peer supporters will be recruited, matched, and provide ongoing support to 1-4 study participants.	Behavioral: Peer Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	This clinical marker of diabetes control will be measured via laboratory tests (blood draw)	Labs will be drawn at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Blood Pressure	All participants will receive an at-home Omron blood pressure monitor and will take two readings during each assessment	Readings will be taken at 4 assessment points: At baseline, 3-months, 6-months, and 12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes self-care behaviors	Survey will utilize questions adapted from the Diabetes Self-Management Questionnaire - Revised (DSMQ-R)	This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Uptake of social care assistance	Survey items assessing intervention utilization and resource uptake	This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Successfully addressing social/financial need	Survey items will assess the extent to which participants social and/or financial needs are being addressed	This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
Treatment-related financial stress	Survey will utilize the COST-FACIT scale (de Souza et al., 2017), adapted for diabetes	This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
Cost-related non-adherence behaviors	Survey questions adapted from Medicare Current Beneficiary Survey (MCBS) & National Health Interview Survey (NHIS)	This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Social Support; Disease Management; Financial Support; Intervention Strategies
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Health Services; Health Care Facilities Workforce and Services; Social Work
• Other Study ID Numbers: HUM00284695; 1R01DK142645-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All de-identified clinical data will be made available upon request. Protocols and details on instrument settings, data transformation, and analysis will be available in the accompanying plain-text README. A data dictionary will be provided for the clinical dataset, defining units of measurement as necessary to understand and reuse it.

Underlying Primary Data that is de-identified will be made broadly available through an appropriate data repository, in compliance with extant data use agreements. When permitted by data use agreements with our partnering agencies, underlying primary data will be shared simultaneously with Publication and made immediately accessible through release under the Creative Commons Attribution 4.0 Generic License or an equivalent license, or otherwise dedicated to the public domain. Study protocols, survey instruments, codebooks, and consent forms will be made available to facilitate the interpretation of the scientific data.

• IPD Sharing Time Frame: Data access will be available for at least 10 years (anticipated between July 2030 and July 2040) or for as long as the repository exists.
• IPD Sharing Access Criteria: To safeguard privacy right of participants, the PI and corresponding staff will assure that all potentially identifying data fields are anonymized prior to release. All consent forms will include an extensive statement regarding data privacy and steps to protect data. Underlying Primary Data that are free of identifiers but contain sensitive information are immediately released with no fee for access but are deposited in controlled access repositories after receipt of a written request to the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No