- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02624739
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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:
- Assess usability of the system (primary measurement is % of successful data transmissions from participants' homes, secondary measurement includes scores from the System Usability Scale)
- 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
|
One year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
System Usability
Tidsramme: One year
|
Usability of the system by the clinical care team as measured by a System Usability Scale
|
One year
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Healthcare Utilization
Tidsramme: One year
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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
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One year
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HF Drug Compliance
Tidsramme: One year
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Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
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One year
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HF Drug Changes
Tidsramme: One year
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Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
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One year
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Biomarkers
Tidsramme: One year
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Trends in HF-specific biomarkers: NT-proBNP, ST2
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One year
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Respiration Patterns
Tidsramme: One year
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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.
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One year
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Sleeping Patterns
Tidsramme: One year
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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.
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One year
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Maria Patarroyo-Aponte, MD, West Penn Allegheny Health System
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AGH-11-15-01
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