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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Usual Care; Behavioral: Digital health monitoring with financial incentives; Behavioral: IMPaCT Community Health Worker

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Clinical Support; Participants will continue with their usual diabetes care provided by their clinic. Participants will receive a free wireless glucometer on the day of enrollment if they do not already have one.	Other: Usual Care; Usual Care
Active Comparator: DFI Alone; Participants will receive a free wireless glucometer on the day of enrollment if they don't already have one. To encourage habit formation, for the first 6 weeks of the trial, participants will be eligible for a daily lottery incentive for every day that they use their glucometer. Investigators will use an approach similar to what we have used in prior DFI trials: the lottery will provide infrequent large payoffs (a 1 in 100 chance of a US$50 reward) and more frequent small payoffs (an 18 in 100 chance of a US $5 reward). Participants who draw the winning lottery number, but did not check their glucose the day prior will receive an automated text or e-mail message informing them what earnings they would have won had they used their glucometer. After 6 weeks, investigators will terminate the lottery but continue to monitor patients' adherence to glucose self-monitoring.	Behavioral: 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.
Experimental: Hybrid DFI CHW; Participants in the hybrid intervention will receive a wireless glucometer if they don't already have one and financial incentives just as in the DFI intervention. However, any individuals who have low adherence (no self-monitoring) or elevated glucose readings (>300 mg/dL) for >30% of days over any 2 week period in the first 12 weeks of the study will be assigned to receive ongoing community health worker (CHW) support for the duration of the 24-week study period.	Behavioral: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycosylated Hemoglobin	Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: The Commonwealth Fund

Publications and helpful links

General Publications

• 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. 2022 May 17:1-7. doi: 10.1007/s11606-022-07639-6. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): July 28, 2020

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Community Health Worker; Financial Incentives
• Other Study ID Numbers: 20191985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No