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Digital CHW Support for Heart Failure

N/A

Recruiting

Led By Jocelyn Carter, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

HF diagnosis

Must not have

Cognitive deficits that prevent digital or human engagement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trialtests if a digital health worker intervention can reduce heart failure readmissions, compared to usual care with a health worker.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions (digital tools and community support), traditional side effects like you'd expect from medications aren't applicable. However, participants may experience privacy concerns or stress related to technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart Failure Knowledge

Intervention Acceptability

Intervention Feasibility

Secondary study objectives

30-day Emergency Department visit rate

30-day missed appointment rate

30-day readmission rate

Other study objectives

Pharmaceutical Preparations

Patient Satisfaction

Quality of Life (patient perceptions and attitudes, functionality and mobility)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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 CareActive Control1 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.

0 / 3Eligibility criteria met