Health TrialsbyHealthPanel

Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)

ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 decision-making: Self-identifies as primarily responsible for making own healthcare financial decisions (to address concerns about young adults dependent on family support).

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

694 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: FindHelpExperimental treatment 1 intervention
Group B: FindHelp with Social WorkerExperimental treatment 2 interventions
Group C: FindHelp with Financial NavigationExperimental treatment 2 interventions
Group D: FindHelp + Peer SupportExperimental treatment 2 interventions
Group E: FindHelp + Peer Support with Social WorkerExperimental treatment 3 interventions
Group F: FindHelp + Peer Support w/ Financial NavigationExperimental treatment 3 interventions
Group G: Peer SupportersOther 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

This clinical marker of diabetes control will be measured via laboratory tests (blood draw)

Time frame
Labs will be drawn at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
2

Blood Pressure

All participants will receive an at-home Omron blood pressure monitor and will take two readings during each assessment

Time frame
Readings will be taken at 4 assessment points: At baseline, 3-months, 6-months, and 12-months

Secondary outcomes

1

Diabetes self-care behaviors

Survey will utilize questions adapted from the Diabetes Self-Management Questionnaire - Revised (DSMQ-R)

Time frame
This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months
2

Uptake of social care assistance

Survey items assessing intervention utilization and resource uptake

Time frame
This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
3

Successfully addressing social/financial need

Survey items will assess the extent to which participants social and/or financial needs are being addressed

Time frame
This outcome will be assessed at 3 assessment points: At 3-months, 6-months, and 12-months
4

Treatment-related financial stress

Survey will utilize the COST-FACIT scale (de Souza et al., 2017), adapted for diabetes

Time frame
This outcome will be assessed at 4 assessment points: At baseline, 3-months, 6-months, and 12-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: