Reassure Remote Respiration Monitoring in Heart Failure Patients

NCT02624739 | Terminated Results

• 1 other identifier: AGH-11-15-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

respiration rate, sleep

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• System Usability

  One year

• Healthcare Utilization

  One year

• HF Drug Compliance

  One year

• HF Drug Changes

  One year

• Biomarkers

  One year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Reassure Non-Contact Respiration Monitor DEVICE

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Paul Phillips
• Organization: ResMed

paul.phillips@resmed.com

01 906 8861

Study Officials

• Maria Patarroyo-Aponte, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: December 8, 2015
• Study Start: December 1, 2015
• Primary Completion: June 2, 2016
• Study Completion: July 1, 2016
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-04

Locations

US (1)