Clinical trial NCT04782973: Disease Management Platform for Heart Failure (DMP-HF)
Official title: A Novel Disease Management Platform Delivered Via Smartphone Application for the Management of Patients With Heart Failure: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-03-04
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Implementation
timeFrame: 6 months
measure: Perceived Value of Disease Management Platform
timeFrame: 60 days
Secondary outcomes:
measure: Disease Management Platform Engagement
timeFrame: 60 days
measure: Health Status Change With Use of Disease Management Platform
timeFrame: 60 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Pradeep Natarajan, MD
role: PRINCIPAL_INVESTIGATOR
References: