Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Reassure Remote Respiration Monitoring in Heart Failure Patients

20. april 2021 oppdatert av: ResMed

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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

17

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Allegheny General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Aktiv komparator: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Successful Data Transmissions
Tidsramme: One year
Number of successful data transmissions compared to number of possible data transmissions
One year
Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire
Tidsramme: One year
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
One year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
System Usability
Tidsramme: One year
Usability of the system by the clinical care team as measured by a System Usability Scale
One year
Healthcare Utilization
Tidsramme: One year
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
Tidsramme: One year
Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
One year
HF Drug Changes
Tidsramme: One year
Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
One year
Biomarkers
Tidsramme: One year
Trends in HF-specific biomarkers: NT-proBNP, ST2
One year
Respiration Patterns
Tidsramme: One year
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
Tidsramme: One year
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ResMed

Etterforskere

  • Hovedetterforsker: Maria Patarroyo-Aponte, MD, West Penn Allegheny Health System

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2015

Primær fullføring (Faktiske)

2. juni 2016

Studiet fullført (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først innsendt

20. november 2015

Først innsendt som oppfylte QC-kriteriene

3. desember 2015

Først lagt ut (Anslag)

8. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AGH-11-15-01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere