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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03939793

Recruitment Status Completed

First Posted May 7, 2019

Last update posted August 25, 2020

Study Description

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.

  • Condition or Disease:Diabetes Mellitus
  • Intervention/Treatment: Behavioral: IMPaCT Community Health Worker
    Behavioral: Digital health monitoring with financial incentives
    Other: Usual Care
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Health Services Research
  • 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: July 2020
  • Actual Study Completion Date: July 2020
Arms and interventions
Arm Intervention/treatment
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: 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.

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.
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.
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
Outcome Measures
  • Primary Outcome Measures: 1. Adherence Rate [ 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 Outcome Measures: 1. Change in Glycosylated Hemoglobin [ Time Frame: 6 months ]
    Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts
Locations

United States, Pennsylvania
Penn Medicine
Philadelphia

Sponsors and Collaborators

University of Pennsylvania

The Commonwealth Fund

More Information
  • Responsible Party: University of Pennsylvania
  • ClinicalTrials.gov Identifier: NCT03939793 History of Changes
  • Other Study ID Numbers: 20191985
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: August 25, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Pennsylvania: Community Health Worker Financial Incentives