NCT05130008

Brief Summary

The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

September 23, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 20, 2025

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

November 10, 2021

Results QC Date

December 28, 2024

Last Update Submit

April 2, 2025

Conditions

Heart Failure，Congestive

Keywords

community health worker caredigital platformremote monitoringreadmissionsclinical trialheart failure

Outcome Measures

Primary Outcomes (2)

  • Intervention Acceptability

    Proportion of patients indicating that they would be willing to use the intervention again

    30 days

  • Intervention Feasibility

    Proportion of patients that used the intervention during the study period

    30 days

Secondary Outcomes (4)

  • 30-day Readmission Rate

    30 days

  • 30-day Missed Appointment Rate

    30 days

  • 30-day Emergency Department Visit Rate

    30 days

  • Heart Failure Knowledge (Associated With a Subset of Participants Assessed for This Measure Prior to Being Randomized to the Intervention or Control Arm)

    Baseline

Other Outcomes (3)

  • Patient Satisfaction

    30 days

  • Medication Compliance

    30 days

  • Quality of Life (Patient Perceptions and Attitudes, Functionality and Mobility)

    30 days

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Digitally-enabled CHW Care

Usual CHW Care

ACTIVE COMPARATOR

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.

Behavioral: Usual CHW Care

Interventions

Digitally-enabled CHW CareOTHER

Patients will be paired with a CHW and be encouraged to wear the arm biosensor continuously, take blood pressure daily, respond to short symptom assessments daily or every other day, complete weekly life quality surveys, watch weekly HF educational videos and engage in digital (e.g., video visit) and phone-based, and in-person CHW interactions. Each participant will have access to the digital platform and CHW staff during their hospitalization and for the 30 days following discharge for a typical study duration of approximately 32-35 days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

Intervention
Usual CHW CareBEHAVIORAL

Patients will be paired with a CHW for 30-days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.

Usual CHW Care

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • HF diagnosis
  • English proficiency
  • Residence within 30 miles of MGH
  • Being cared for by a cardiologist or primary care provider who manages their HF
  • Current use and ownership of a smart phone

You may not qualify if:

  • Cognitive deficits that prevent digital or human engagement
  • Lack of health insurance
  • Invoked health proxy or guardianship status
  • History of smart phone use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

  • Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.

    PMID: 23616602BACKGROUND

  • McHugh MD, Ma C. Hospital nursing and 30-day readmissions among Medicare patients with heart failure, acute myocardial infarction, and pneumonia. Med Care. 2013 Jan;51(1):52-9. doi: 10.1097/MLR.0b013e3182763284.

    PMID: 23151591BACKGROUND

  • Abdel-All M, Putica B, Praveen D, Abimbola S, Joshi R. Effectiveness of community health worker training programmes for cardiovascular disease management in low-income and middle-income countries: a systematic review. BMJ Open. 2017 Nov 3;7(11):e015529. doi: 10.1136/bmjopen-2016-015529.

    PMID: 29101131BACKGROUND

  • Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27.

    PMID: 29703724BACKGROUND

  • Carter JAC, Swack N, Isselbacher E, Donelan K, Thorndike A. Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Pilot Randomized Controlled Trial. JMIR Cardio. 2024 Aug 8;8:e59948. doi: 10.2196/59948.

    PMID: 38959294DERIVED

  • Carter J, Swack N, Isselbacher E, Donelan K, Thorndike A. Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 6;13:e55687. doi: 10.2196/55687.

    PMID: 38216543DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Jocelyn Carter
Organization
Massachusetts General Hospital
jcarter0@mgh.harvard.edu
617 724 9000

Study Officials

  • Jocelyn Carter, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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
Masking Details
The outcomes assessor team will be blinded to the intervention assignments of participants. Due to the nature of the intervention, the participants, the investigator, and the care providers are unable to be blinded to the participant assignments.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician- Scientist

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 22, 2021

Study Start

September 23, 2022

Primary Completion

June 1, 2023

Study Completion

August 31, 2024

Last Updated

April 20, 2025

Results First Posted

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The data can be available by request only after academic journal publication. Any formal requests should be sent by external research teams and will be reviewed by the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will become available upon request after academic journal publication.
Access Criteria
Access criteria will be determined and confirmed by the corresponding author upon review of the formal data request.

Locations

US(1)