Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)

Official title

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

Overview

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.

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.

Interventions

• 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 the
• 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 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.

Primary outcome measures

• HbA1c [Time frame: Labs will be drawn at 4 assessment points: At baseline, 3-months, 6-months, and 12-months]
• Blood Pressure [Time frame: Readings will be taken at 4 assessment points: At baseline, 3-months, 6-months, and 12-months]

Secondary outcome measures (5)

• Diabetes self-care behaviors [Time frame: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months]
• Uptake of social care assistance [Time frame: This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months]
• Successfully addressing social/financial need [Time frame: This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months]
• Treatment-related financial stress [Time frame: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months]
• Cost-related non-adherence behaviors [Time frame: This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months]

Eligibility criteria

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 ≥8.0% for individuals ≥71 years of age AND A1c levels <7.5% for individuals ≤70 years of age and <8.0% 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Double blind

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07676188 · HUM00284695 · 1R01DK142645-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗