Digital CHW Support for Heart Failure

Overseen By Anne Walton, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive deficits, Lack of insurance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital support system for people with heart failure to determine if it can reduce hospital readmissions within 30 days. Participants will collaborate with a community health worker (CHW) and use digital tools such as a mobile app, digital weight scale, and blood pressure monitor. The trial compares this digitally-enabled CHW care approach to the usual care provided by a CHW. Individuals diagnosed with heart failure, who own a smartphone, and live within 30 miles of Massachusetts General Hospital might be suitable for this study. As an unphased study, this trial provides a unique opportunity to explore innovative digital health solutions for managing heart failure.

What prior data suggests that this digitally-enabled CHW care is safe for heart failure patients?

Research has shown that using digital tools with support from community health workers (CHWs) is generally safe and well-received by patients. In one study, patients found these tools easy to use and helpful, with no major safety issues reported. The digital tools included a mobile app, a digital weight scale, and a digital blood pressure monitor. Patients used these tools with CHW support throughout the study.

These tools aim to track heart health and reduce hospital readmissions. While the study focused on patients with heart failure, the tools appear promising for home health monitoring. No evidence of serious problems has emerged from using these tools. Overall, this approach seems safe and well-accepted by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digitally-enabled Community Health Worker (CHW) care for heart failure because it combines personal support with cutting-edge technology. Unlike standard CHW care, which involves regular check-ins, this approach gives patients access to a digital platform with tools like a mobile app, digital weight scale, digital blood pressure monitor, and biosensor armband. These tools enable real-time monitoring and data collection, helping community health workers provide more personalized and timely interventions. This integration of technology aims to improve patient engagement and outcomes by offering more immediate and tailored care.

What evidence suggests that this digitally-enabled CHW care is effective for reducing heart failure readmissions?

Research shows that digital tools used with community health workers (CHWs) can help reduce hospital readmissions for heart failure within 30 days. In this trial, participants in the intervention arm will receive digitally-enabled CHW care, which includes mobile apps and health monitors, along with CHW support. Earlier studies have shown that patients receiving this type of care had fewer readmissions. Early results suggest that patients find this method practical and acceptable. These findings highlight the potential for digital support to improve heart failure care. ^{1 2 3 6 7}

Who Is on the Research Team?

Jocelyn Carter, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who speak English, live within 30 miles of MGH, have a smartphone they use, and are under a cardiologist or primary care provider's care. It's not for those without health insurance, cognitive issues preventing engagement, or who rely on a health proxy.

Inclusion Criteria

Current use and ownership of a smart phone

I have been diagnosed with heart failure.

I am under the care of a cardiologist or primary care provider for my heart failure.

Exclusion Criteria

Lack of health insurance

Invoked health proxy or guardianship status

I have difficulty thinking or remembering that makes it hard for me to use digital devices or interact with people.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a digitally-enabled community health worker intervention or usual CHW care for 30 days

4 weeks

Continuous access to CHW and digital platform

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digitally-enabled CHW Care
• Usual CHW Care

Trial Overview The study compares two types of support for heart failure patients: one using digitally-enabled community health workers and the other using standard community worker care. The goal is to see if digital tools can better prevent hospital readmissions within 30 days after discharge.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Patients identified by the MGH readmission database and the EHR as eligible for the study will be enrolled. Participants will be paired with a community health worker and oriented to the digital platform ( mobile app, digital weight scale, digital blood pressure monitor, biosensor with armband). Participants will have access to the community health worker and the digital platform throughout the 30-day study interval.

Group II: Usual CHW Care Active Control 1 Intervention

Patients identified by the MGH readmission database and the EHR as eligible for the study will be enrolled. Participants will be paired with a community health worker. Participants will have access to the community health worker throughout the 30-day study interval.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38959294

Pilot Randomized Controlled Trial - PubMed - NIH Methods: Adults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05130008

Implementing a Digitally-enabled Community Health ... In preliminary findings, digital platform clinical trial data has shown promise in reducing HF 30-day readmissions. This study will investigate the ...

3. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.11804

Abstract 11804: Implementing a Digitally-Enabled ... Conclusions: A novel intervention combining a digital platform with CHW social needs care in HF was feasible and acceptable. Clinical outcome ...

4. cardio.jmir.org cardio.jmir.org/2024/1/e59948

Pilot Randomized Controlled Trial - JMIR Cardio This pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day ...

5. researchprotocols.org researchprotocols.org/2024/1/e55687/

Feasibility, Acceptability, and Preliminary Effectiveness of a ... This study aims to describe the protocol for a randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of an ...

6. chwcentral.org chwcentral.org/resources/feasibility-acceptability-and-preliminary-effectiveness-of-a-combined-digital-platform-and-community-health-worker-intervention-for-patients-with-heart-failure-pilot-randomized-controlled-trial/

Feasibility, Acceptability, and Preliminary Effectiveness of a ... The study found that using digital tools along with CHW support was feasible and well-received by patients. Those using the digital tools had ...

7. sirenetwork.ucsf.edu sirenetwork.ucsf.edu/tools-resources/resources/feasibility-and-acceptability-combined-digital-platform-and-community

Feasibility and acceptability of a combined digital platform ... Digital platforms designed for remote monitoring of HF can improve clinical outcomes, but their effectiveness has been limited by patient ...