Disease Management Platform for Heart Failure (DMP-HF)

Heart Failure Clinical Trial

— DMP-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782973
• Other study ID #: 2020P004027
• Status: Completed
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: November 16, 2021

Study information

• Verified date: December 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 16, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• AMAZE (TM) Disease Management Platform
Providing patients with smartphone app that will integrate with provider facing dashboard within electronic medical record.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of implementing the AMAZE™ disease management platform intervention after in-patient heart failure hospitalization.	Feasibility will be measured using conversion rate (percent of patients approached who enroll on the disease management platform).	60 days
Primary	Patient perceived value of the AMAZE™ disease management platform.	Perceived value will be measured using the participants mHealth App Usability Questionnaire (MAUQ) score.	60 days
Secondary	Heart failure symptom changes using the Kansas City Cardiomyopathy Questionnaire (KCCQ).	Heart failure symptoms will be measured as the changes in KCCQ scores between the 30 day and 60 day time-points.	60 days
Secondary	Patient daily log compliance.	Daily log compliance will be measured after 60 days using the total number of days patient completes daily log in the AMAZE™ app out of total days patient is enrolled in the app.	60 days
Secondary	Patient app usage.	Patient app usage will be measured as the number of days the patient engages (i.e. completes daily log, sends a message) with the app at least once a day during the study period.	60 days
Secondary	Patient app messaging.	Patient app messaging will be measured as the number of messages sent by the patient during the 60 day study period.	60 days
Secondary	Changes in hospital readmissions.	Hospital readmission rates in the enrolled study group will be compared to readmission rates in historical control groups.	60 days
Secondary	Use of ancillary healthcare resources.	Rates ancillary healthcare resources (i.e. emergency room visits, urgent care visits, unexpected ambulatory care visits, cardiac rehab) in the enrolled study group will be compared to rates of usage in a historical control group.	60 days