Reassure Remote Respiration Monitoring in Heart Failure Patients
20 april 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny General Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent Successful Data Transmissions
Tidsram: 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
Tidsram: One year
|
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
|
One year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
System Usability
Tidsram: One year
|
Usability of the system by the clinical care team as measured by a System Usability Scale
|
One year
|
|
Healthcare Utilization
Tidsram: 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
Tidsram: One year
|
Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
|
One year
|
|
HF Drug Changes
Tidsram: One year
|
Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
|
One year
|
|
Biomarkers
Tidsram: One year
|
Trends in HF-specific biomarkers: NT-proBNP, ST2
|
One year
|
|
Respiration Patterns
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Maria Patarroyo-Aponte, MD, West Penn Allegheny Health System
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2015
Primärt slutförande (Faktisk)
2 juni 2016
Avslutad studie (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
20 november 2015
Först inskickad som uppfyllde QC-kriterierna
3 december 2015
Första postat (Uppskatta)
8 december 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AGH-11-15-01
Läkemedels- och apparatinformation, studiedokument
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produkt tillverkad i och exporterad från U.S.A.
Nej
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