Reassure Remote Respiration Monitoring in Heart Failure Patients

Initial Assessment of the Usability of Remote Monitoring of Respiration Parameters in the Routine Management of Heart Failure Patients

This study is designed to descriptively assess improvement in quality of life and test the usability of remotely monitored respiration parameters in the routine management of recently discharged heart failure patients. It will consist of two arms: (i) intervention, and (ii) control. Participants will be randomized to either arm at time of enrollment. Every participant enrolled in the study will receive a device for remote monitoring.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: Reassure Non-Contact Respiration Monitor

Detailed Description

Heart failure ('HF') presents an increasing social and economic burden, especially with respect to HF related hospitalizations. Some commentators suggest that these costs may double within the next two decades. Respiration patterns are well acknowledged as having diagnostic and prognostic value in HF. In this preliminary study, the investigators assess the usability of remote monitoring of respiration parameters in the routine management of HF patients.

Objectives: (primary and important secondary objectives)

The primary aims are:

1. Assess usability of the system (primary measurement is % of successful data transmissions from participants' homes, secondary measurement includes scores from the System Usability Scale)
2. Assess quality of life (as measured using the KCCQ) for HF patients monitored with a non-contact respiration monitor which can be used by clinicians to guide standard therapy.

Other key secondary objectives include examining trends in healthcare utilization, descriptively assessing any differences in care patterns post hoc between participants.

As part of the study plan , the investigators will also analyze respiration and sleeping patterns from the raw data files to assess the prevalence of unusual breathing patterns such as sleep apnea in newly discharged HF patients and how these patterns may be linked to outcomes. These analyses will be executed retrospectively on a population rather than individual participant basis and will not be used to inform individual treatment plans.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females age ≥18 years old
• Patients admitted to hospital for worsening of heart failure; Worsening of heart failure is defined as symptoms consistent with worsening of heart failure, including dyspnea and an elevated BNP. Patients must have existing diagnosis of heart failure, either preserved ejection fraction or reduced ejection fraction (HFpEF or HFrEF)
• Weight ≥35 kg
• Pre-Menopausal Women ≥18 years of age must have a negative urine/serum pregnancy test or pre-menopausal women with evidence of surgical sterilization or post-menopausal women.
• Must qualify for standard home care post discharge
• Must be able to read and understand English and consent for themselves

Exclusion Criteria:

• Under 18 years of age
• Participant is on a form of non-invasive positive airway pressure ventilation (in such cases, respiratory rates and variability will reflect combined physiology plus machine effect)
• Participant has an existing diagnosis in the medical record for sleep disordered breathing, whether on therapy or not
• Participant has cognitive impairment (determined by physician) that will make it hard for them to follow instructions regarding therapy usage
• BMI> 40
• Patients who are discharged to hospice care, Skilled Nursing Facilities or Long Term Acute Care facilities
• Patients who are actively being monitored using a pulmonary arterial pressure monitor (CardioMEMs)
• Patients with COPD GOLD Stage III or IV
• Planned procedures at time of discharge that will occur within timeframe of study that will require hospitalization etc.
• Participant declines to participate at any time.
• Patients involved in therapy intervention clinical trials
• Any investigational drug use within 30 days prior to enrollment.
• Pregnant or lactating females.
• Participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
• Participants who have no cellular coverage at their primary residence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Reassure Non-Contact Respiration Monitor: Respiration parameters transmitted by the Reassure device will be evaluated daily by the study team and participants will be contacted for further evaluation if a change in respiration patterns is noted. Participants will continue with standard of care heart failure treatment.	Device: Reassure Non-Contact Respiration Monitor; Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep.
Active Comparator: Control; Reassure Non-Contact Respiration Monitor: Respiration parameters will be transmitted and stored, but there will be no active evaluation of respiration patterns. Participants will continue with standard of care heart failure treatment.	Device: Reassure Non-Contact Respiration Monitor; Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Successful Data Transmissions	Number of successful data transmissions compared to number of possible data transmissions	One year
Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire	Quality of life as measured by Kansas City Cardiomyopathy Questionnaire	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability	Usability of the system by the clinical care team as measured by a System Usability Scale	One year
Healthcare Utilization	Trends in healthcare utilization and care patterns as measured by numbers of home visits, outpatient visits, all-cause hospitalizations, HF related hospitalizations, lengths of stay	One year
HF Drug Compliance	Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine	One year
HF Drug Changes	Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine	One year
Biomarkers	Trends in HF-specific biomarkers: NT-proBNP, ST2	One year
Respiration Patterns	Retrospective exploratory analysis of respiration rate measured by the Reassure device compared to participant outcomes (eg, status at end of study, changes in medications, biomarkers, etc) to evaluate potential predictive trends for use in designing future studies.	One year
Sleeping Patterns	Retrospective exploratory analysis of sleeping patterns measured by the Reassure device compared to participant outcomes (eg, status at end of study, changes in medications, biomarkers, etc) to evaluate potential predictive trends for use in designing future studies.	One year

Collaborators and Investigators

• Sponsor: ResMed
• Investigators: Principal Investigator: Maria Patarroyo-Aponte, MD, West Penn Allegheny Health System

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 2, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: respiration rate, sleep
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AGH-11-15-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No