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

NCT03939793 | Completed Results DMC

• 1 other identifier: 20191985
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Community Health Worker; Financial Incentives

Outcome Measures

Primary Outcomes (1)

• Glucose Self-monitoring Adherence

  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 Outcomes (1)

• Change in Glycosylated Hemoglobin

  6 months

Study Arms (3)

Usual Clinical Support

PLACEBO COMPARATOR

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

DFI Alone

ACTIVE COMPARATOR

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

Hybrid DFI CHW

EXPERIMENTAL

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; Behavioral: Digital health monitoring with financial incentives

Interventions

IMPaCT Community Health Worker BEHAVIORAL

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. 1. 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. 2. 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.

Hybrid DFI CHW

Digital health monitoring with financial incentives BEHAVIORAL

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.

DFI Alone; Hybrid DFI CHW

Usual Care OTHER

Usual Care

Usual Clinical Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• The Commonwealth Fund: collaborator

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 35581452 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The COVID pandemic may have led to a higher-than-expected rate of loss to follow-up at 6 months. A COVID-19 modification truncated our primary outcome from 6 to 3 months. Unlike many DHI requiring smartphones, we only required participants to have a basic cell phone; participants needed to text their SMBG to the study platform which may have increased attrition. Because we used low-tech glucometers covered by Medicaid, we extracted data from the physical device, resulting in some missing data.

Results Point of Contact

• Title: Director of Evaluation
• Organization: Penn Center for Community Health Workers

molly.knowles@pennmedicine.upenn.edu

267-624-5465

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 7, 2019
• Study Start: May 15, 2019
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)