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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heart Failure Knowledge

Intervention Acceptability

Intervention Feasibility

Secondary outcome measures

30-day Emergency Department visit rate

30-day missed appointment rate

30-day readmission rate

Other outcome measures

Pharmaceutical Preparations

Patient Satisfaction

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,998 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,931 Previous Clinical Trials

13,198,395 Total Patients Enrolled

Jocelyn Carter, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Digitally-enabled CHW Care Clinical Trial Eligibility Overview. Trial Name: NCT05130008 — N/A

Congestive Heart Failure Research Study Groups: Intervention, Usual CHW Care

Congestive Heart Failure Clinical Trial 2023: Digitally-enabled CHW Care Highlights & Side Effects. Trial Name: NCT05130008 — N/A

Digitally-enabled CHW Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130008 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the eligibility criteria for participation in this research?

"This clinical trial is looking to enrol 50 patients aged between 18 and 99 who have been diagnosed with heart failure. To be eligible, the patient must also speak English fluently, live within 30 miles of Massachusetts General Hospital, receive care from a cardiologist or primary care provider that manages their HF condition, possess a smartphone device, as well as fulfil other requirements."

Answered by AI

Are there any further opportunities to join this clinical investigation?

"The current listing on clinicaltrials.gov indicates that this medical investigation is actively searching for participants, with the original posting date being August 12th 2022 and most recent updates occurring November 2nd 2022."

Answered by AI

Could individuals aged 40 and above partake in this trial?

"To be eligible for this clinical trial, individuals must range from 18 to 99 years old. Separately, there are 22 trials accessible by minors and 690 specialized studies available to those aged 65 and above."

Answered by AI

What is the upper limit of enrollees for this clinical experiment?

"Affirmative. As evidenced by the information hosted on clinicaltrials.gov, this trial is actively seeking participants, having first been posted to the website on August 12th 2022 and last updated on November 2nd of that same year. The recruitment process calls for fifty individuals from a single medical centre."

Answered by AI

Recent research and studies

Circulation: Heart FailureJournal

Forecasting the Impact of Heart Failure in the United States

Heidenreich, Paul A., Nancy M. Albert, Larry A. Allen, David A. Bluemke, Javed Butler, Gregg C. Fonarow, John S. Ikonomidis, et al.. 2013. “Forecasting the Impact of Heart Failure in the United States”. Circulation: Heart Failure. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/hhf.0b013e318291329a.

Diabetes CareJournal

Outcomes at 18 Months from a Community Health Worker and Peer Leader Diabetes Self-management Program for Latino Adults

Spencer, Michael S., Edith C. Kieffer, Brandy Sinco, Gretchen Piatt, Gloria Palmisano, Jaclynn Hawkins, Alana Lebron, et al.. 2018. “Outcomes at 18 Months from a Community Health Worker and Peer Leader Diabetes Self-management Program for Latino Adults”. Diabetes Care. American Diabetes Association. doi:10.2337/dc17-0978.

clinicaltrials.govStudy

Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure

Jocelyn Carter 2022. "Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130008.

All > Heart Failure With Preserved Ejection Fraction > Congestive Heart Failure