Disease Management Platform for Heart Failure (DMP-HF)

NCT04782973 | Completed Results

• 1 other identifier: 2020P004027
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

AMAZE™ is a disease management platform (DMP) designed to educate patients about heart failure, help engage them in healthy behaviors and assist them in taking their medications as prescribed. This study will assess whether the AMAZE™ smartphone-based application ("app") can help heart failure patients take better care of themselves after discharge from an inpatient heart failure admission at Massachusetts General Hospital (MGH). The primary objective is to demonstrate feasibility and perceived value of the AMAZE™ platform in clinical practice. The study will also explore whether the use of the AMAZE™ platform for 60 days post-discharge leads to a reduction in hospital readmission, emergency department, urgent care and unexpected ambulatory care visits. The impact of the AMAZE™ platform on participant reported quality of life outcomes and perception of overall medical care will also be examined.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Feasibility of Implementation

  Feasibility of implementing the AMAZE™ platform is assessed in terms of the number of patients who completed the study.

  6 months

• Perceived Value of Disease Management Platform

  Perceived value was measured using the participants' scoring of the platform's features in the mHealth App Usability Questionnaire (MAUQ). The questionnaire has 21 questions, with scores were based on a scale of 1 (disagree) to 7 (agree).

  60 days

Secondary Outcomes (2)

• Disease Management Platform Engagement

  60 days

• Health Status Change With Use of Disease Management Platform

  60 days

Study Arms (1)

Intervention Group - AMAZE™ Disease Management Platform

OTHER

Eligible patients 21+ years with a diagnosis of HF admitted to MGH cardiology services. The intervention group is exposed to the AMAZE™ app for 60 days. Participants will interact with a nurse for a 7-day discharge follow-up call, a medication reconciliation, assess understanding of heart meds, assess patients' HF symptoms, provide tailored guidance, set goals related to medication adherence, exercise, diet, and other health behaviors. The nurse will coordinate with cardiology teams to streamline med refills, cardiology appointments, and cardiac rehabilitation referrals. The nurse and patient will connect via telephone and in-app messaging, to address patients' concerns and state of health.

Other: AMAZE (TM) Disease Management Platform

Interventions

AMAZE (TM) Disease Management Platform OTHER

Providing patients with smartphone app that will integrate with provider facing dashboard within electronic medical record.

Intervention Group - AMAZE™ Disease Management Platform

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>21 years) admitted to MGH Cardiology services (Ellison 10 and 11) with a primary diagnosis of heart failure \[HFrEF(\<40%), HFmEF(40-49%) HFpEF(≥50%)\] (or to BWH Cardiology services for BWH EHR-based controls)
• Has a smartphone or iPad and is willing to enter health metrics into DMP App and email willing to use for the study
• Access to the internet
• Established or with plan to establish primary cardiologist at MGH (or at BWH for BWH EHR-based controls)
• Discharged home or to self-care (with or without home services)

You may not qualify if:

• Moderate or severe cognitive impairment
• Non-English-speaking
• Palliative management only (comfort measures)
• Does not own a smartphone or iPad (not considered for EHR-based controls)
• Incarcerated

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

isofenphos

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kaavya Paruchuri, MD
• Organization: Massachusetts General Hospital

kparuchuri@mgh.harvard.edu

617-726-1843

Study Officials

• Pradeep Natarajan, 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: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Preventive Cardiology, Assistant Professor of Medicine, Harvard Medical School, Associate Member of the Broad Institute of Harvard and MIT

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 4, 2021
• Study Start: March 11, 2021
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)