Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Pradeep Natarajan, MD
617-724-3526
pnatarajan@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Pradeep Natarajan, MD
617-724-3526
pnatarajan@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.