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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Usual Care
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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.
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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.
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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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Glucose Self-monitoring Adherence
Time Frame: 3 months
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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
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3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Glycosylated Hemoglobin
Time Frame: 6 months
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Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20191985
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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