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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939793
• Other study ID #: 20191985
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: July 28, 2020

Study information

• Verified date: August 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• IMPaCT Community Health Worker
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
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.

Other:
• Usual Care
Usual Care

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	The Commonwealth Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Glycosylated Hemoglobin	Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.	6 months
Primary	Adherence Rate	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	3 months