Reassure Remote Respiration Monitoring in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02624739
• Other study ID #: AGH-11-15-01
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: July 2016
• Est. primary completion date: June 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Successful Data Transmissions	Number of successful data transmissions compared to number of possible data transmissions	One year
Primary	Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire	Quality of life as measured by Kansas City Cardiomyopathy Questionnaire	One year
Secondary	System Usability	Usability of the system by the clinical care team as measured by a System Usability Scale	One year
Secondary	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
Secondary	HF Drug Compliance	Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine	One year
Secondary	HF Drug Changes	Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine	One year
Secondary	Biomarkers	Trends in HF-specific biomarkers: NT-proBNP, ST2	One year
Secondary	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
Secondary	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