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Completed

NCT Number: NCT03939793

Using Digital Health, Financial Incentives, and Community Health Worker Support to Change Health Behavior

This randomized controlled trial tests how digital health monitoring with financial incentives (DFI) and community health worker (CHW) support may affect how a person manages their diabetes. Participants will be randomized to one of three arms: 1) DFI intervention, 2) hybrid DFI/CHW intervention, or 3) usual care. Investigators hypothesize that compared to usual care and DFI alone, the hybrid intervention will lead to more glucose self-monitoring and greater improvements in glycosylated hemoglobin.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

Low-income Americans struggle to stay healthy in the face of real-life challenges such as housing insecurity or trauma. Two interventions show promise for promoting behavior change and improving health outcomes: digital health interventions coupled with financial incentives (DFI) and community health workers (CHWs). Yet, these interventions have limitations; DFI interventions have low uptake and high attrition among vulnerable populations, while CHW interventions are relatively resource intensive.

Investigators propose a 24-week randomized trial of a hybrid DFI/CHW intervention among a population of 150 low-income patients with diabetes. Participants will be randomized to one of three arms: 1) DFI intervention, 2) hybrid DFI/CHW intervention, 3) usual care. Participants assigned to DFI will receive a free wireless glucometer and be eligible for a lottery incentive if they use their glucometer. Participants assigned to the hybrid DFI/CHW intervention will receive the same glucometer and incentives. If they exhibit low adherence to self-monitoring or poor glucose control, they will also receive support from a CHW who would help patients to address underlying socioeconomic barriers and cope with setbacks. Investigators hypothesize that compared to usual care and DFI alone, the hybrid intervention will lead to more glucose self-monitoring and greater improvements in glycosylated hemoglobin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Penn Medicine patients diagnosed with diabetes mellitus.
  • Glycosylated hemoglobin >=9% within the past 6 months.
  • Requires insulin.
  • Uninsured/publicly insured.
  • Residents of high-poverty ZIP codes in West/Southwest Philadelphia.
  • Have access to a cellphone with unlimited text message capabilities.

Exclusion criteria

  • Already have a continuous glucose monitor.
  • Previously enrolled in the study.
  • Currently have an outpatient CHW.
  • Unwilling/unable to provide informed consent.
  • In another study that asks participants to monitor their blood sugar.

Treatment and study plan

IMPaCT Community Health Worker

Behavioral

Once a CHW receives notification of a struggling patient, the CHW will visit the patient at their home within 1-2 days to initiate the IMPaCT intervention.

  • Elements of the standard IMPaCT intervention: During the first home visit, the CHW will use an in-depth semi-structured interview guide to get to know patients holistically and assess for unmet socioeconomic needs. This allows patients to express goals in line with their own needs and preferences. These individualized goals will become the basis for tailored action plans. The CHW will then provide hands-on, tailored support for the remainder of the 24-week study period to help patients achieve their goals.
  • Additional elements to help patients cope with failure: In this study, we will test a refined version of IMPaCT that incorporates two behavioral techniques for coping with failure: positive affect induction and attribution retraining.

Digital health monitoring with financial incentives

Behavioral

Participants are encouraged to use their glucometer to check their blood glucose via bidirectional texting and lottery-based financial incentives, which both serve to reinforce self-monitoring behavior.

Usual Care

Other

Usual Care

Primary outcomes

  1. Glucose Self-monitoring Adherence

    Time frame: 3 months

    constructed by summing the number of days in the study period that the glucometer was used divided by the total number of days in study period

Other outcomes

  1. Change in Glycosylated Hemoglobin

    Time frame: 6 months

    Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • The Commonwealth Fund

Registry information

Official study title

Combining Best Practices for Health Behavior Change: a Randomized Controlled Trial of Digital Health, Financial Incentives and Community Health Worker Support for Vulnerable Populations

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 7, 2019
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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