Reassure Remote Respiration Monitoring in Heart Failure Patients
20 avril 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
17
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15212
- Allegheny General Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percent Successful Data Transmissions
Délai: 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
Délai: One year
|
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
|
One year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
System Usability
Délai: One year
|
Usability of the system by the clinical care team as measured by a System Usability Scale
|
One year
|
|
Healthcare Utilization
Délai: 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
Délai: One year
|
Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
|
One year
|
|
HF Drug Changes
Délai: One year
|
Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
|
One year
|
|
Biomarkers
Délai: One year
|
Trends in HF-specific biomarkers: NT-proBNP, ST2
|
One year
|
|
Respiration Patterns
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Maria Patarroyo-Aponte, MD, West Penn Allegheny Health System
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2015
Achèvement primaire (Réel)
2 juin 2016
Achèvement de l'étude (Réel)
1 juillet 2016
Dates d'inscription aux études
Première soumission
20 novembre 2015
Première soumission répondant aux critères de contrôle qualité
3 décembre 2015
Première publication (Estimation)
8 décembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 mai 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 avril 2021
Dernière vérification
1 avril 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AGH-11-15-01
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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