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

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT03939793
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Study Start: 2019-05-15
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glucose Self-monitoring Adherence	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

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States