Clinical trial NCT03939793: Using Digital Health, Financial Incentives, and Community Health Worker Support to Change Health Behavior
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Community Health Worker
Financial Incentives
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: The Commonwealth Fund
First posted: 2019-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose Self-monitoring Adherence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Change in Glycosylated Hemoglobin
timeFrame: 6 months
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
References:
citation: Whitehouse CR, Knowles M, Long JA, Mitra N, Volpp KG, Xu C, Sabini C, Gerald N, Estrada I, Jones D, Kangovi S. Digital Health and Community Health Worker Support for Diabetes Management: a Randomized Controlled Trial. J Gen Intern Med. 2023 Jan;38(1):131-137. doi: 10.1007/s11606-022-07639-6. Epub 2022 May 17.