Disease Management Platform for Heart Failure (DMP-HF) (DMP-HF)

A Novel Disease Management Platform Delivered Via Smartphone Application for the Management of Patients With Heart Failure: Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: AMAZE (TM) Disease Management Platform

Detailed Description

Heart failure (HF) management and readmissions remain at the top of the list of complex topics in cardiovascular medicine in the United States. Current system-wide programs to curb HF-related hospital readmissions have shown inconsistent results. However, outpatient transitional care supportive programs have been linked to improved HF-related outcomes, including reduced hospital readmissions, in small studies. Small studies also indicate that remote transfer of non-invasive data through telemonitoring (e.g., blood pressure and weight) and structured telephone support may reduce hospital readmissions in a cost-effective manner. The present pandemic has placed significant strains on the link between clinicians and patients highlighting the need for rapid innovation for virtual care.

This study involves the AMAZE™ DMP, developed by AstraZeneca, to provide a unified experience for the management of HF patients throughout their patient care journey. The platform will integrate multiple systems, including a smartphone-based application where patients can enter daily mood, symptoms, weight measures, and vital signs such as blood pressure (BP) and medication adherence. This input will feed directly to a clinician facing dashboard embedded within the electronic medical record that will allow the clinical care team to access real-time views of patients' states both in and out of clinic.

Patients will be identified via an automated electronic medical record (EMR)-based, computer-based algorithm and eligibility will be manually verified. Participants will be enrolled in the study following an inpatient HF admission at Massachusetts General Hospital (MGH).

Clinical providers and study staff will be able to view and monitor the subjects' AMAZE™ smartphone application entries within the electronic medical record via the AMAZE™ provider dashboard. The AMAZE™ secure messaging function will be used for study and clinical communications between the patient, study staff and clinical care team to facilitate outpatient HF management. The AMAZE™ smartphone application (app) will indirectly assess the patient's quality of life (Kansas City Cardiomyopathy Questionnaire - KCCQ), as well as patient satisfaction with the app (mHealth App Usability Questionnaire - MAUQ). For clinicians, the MAUQ will measure provider satisfaction with the AMAZE™ dashboard.

Baseline demographics and study outcomes will be assessed via direct patient survey by study staff at pre-specified time points (enrollment, 30-days post enrollment, 60-days post enrollment). Outcomes will include medication changes, hospitalizations, emergency department presentations, urgent care visits, primary care or cardiology office visits and cardiac rehabilitation enrollment. Medical history, including labs, procedures, and diagnoses will be collected from the electronic medical record and recorded in REDCap. The AMAZE™ app will track medication adherence, daily symptom(s) log, blood pressure, weight, heart rate and activity when entered by participants into a daily log. Participants will be asked and encouraged to enter information into the smartphone-based app daily by study staff.

The primary goal of the present proposal will be to generate evidence on the feasibility and perceived value of the AMAZE™ platform implemented in clinical practice. The outcomes will be measured using conversion rate (study enrollment rate among total number of eligible patients) and utilization rate (percentage of days participants engaged with the AMAZE™ app during the 60-day study period). This study is a first necessary step before testing efficacy in a large multi-center study.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intervention Group - AMAZE™ Disease Management Platform; 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; Providing patients with smartphone app that will integrate with provider facing dashboard within electronic medical record.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Management Platform Engagement	Participants' engagement with the platform was measured in terms of daily logs completed and number of messages sent to the nurse navigator.	60 days
Health Status Change With Use of Disease Management Platform	Health status was ascertained based on participants' responses to the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ), which assesses heart failure symptoms and impact on quality of life. The questionnaire was administered at baseline, 30 days after enrolling in the study, and 60 days after enrolling in the study. Change in health status was measured by the difference in scores between the first and last KCCQ completed (baseline and 60 days after). KCCQ scores range from 0 (very poor health) to 100 (excellent health). An increase in score indicates improvement in health status and a decrease indicates worsening health status. The measure we use here reports the change in KCCQ scores from a 15-point decrease to a 15-point increase from baseline in increments of 5 points.	60 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Pradeep Natarajan, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2020P004027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No