Diabetes MellitusNCT03939793
Using Digital Health, Financial Incentives, and Community Health Worker Support to Change Health Behavior
A study testing IMPaCT Community Health Worker and Digital health monitoring with financial incentives in people with Diabetes Mellitus, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- IMPaCT Community Health Worker and Digital health monitoring with financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 28 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- IMPaCT Community Health Worker, Digital health monitoring with financial incentives, Usual Care
- Keywords
- Community Health Worker, Financial Incentives
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPaCT Community Health WorkerBehavioural
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 incentivesBehavioural
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.
Usual CareOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: IMPaCT Community Health Worker; Behavioral: Digital health monitoring with financial incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start15 May 2019
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- The Commonwealth Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939793
- Sponsor's protocol ID
- 20191985
- Status last verified
- Aug 2024
- First submitted
- 3 May 2019
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2023 Jan;38(1):131-137. doi: 10.1007/s11606-022-07639-6. Epub 2022 May 17.
PubMed 35581452
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03939793
- Acronym / sponsor ID
- 20191985
- Conditions
- Diabetes Mellitus
- Keywords
- Community Health Worker, Financial Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- The Commonwealth Fund
- Study start
- 15 May 2019 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Clinical Support | Placebo comparator | Other: Usual CareParticipants 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. |
| DFI Alone | Active comparator | Behavioral: Digital health monitoring with financial incentivesParticipants 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. |
| Hybrid DFI CHW | Experimental | Behavioral: IMPaCT Community Health Worker, Behavioral: Digital health monitoring with financial incentivesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPaCT Community Health WorkerOnce 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. | Behavioural | Hybrid DFI CHW |
| Digital health monitoring with financial incentivesParticipants 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. | Behavioural | DFI Alone, Hybrid DFI CHW |
| Usual CareUsual Care | Other | Usual Clinical Support |
Primary outcome
Glucose Self-monitoring Adherence
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35581452Whitehouse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPaCT Community Health Worker and Digital health monitoring with financial incentives in people with Diabetes Mellitus, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Self-monitoring Adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03939793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.