Reassure Remote Respiration Monitoring in Heart Failure Patients
20 de abril de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
17
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny General Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent Successful Data Transmissions
Periodo de tiempo: 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
Periodo de tiempo: One year
|
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
|
One year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
System Usability
Periodo de tiempo: One year
|
Usability of the system by the clinical care team as measured by a System Usability Scale
|
One year
|
|
Healthcare Utilization
Periodo de tiempo: 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
Periodo de tiempo: One year
|
Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
|
One year
|
|
HF Drug Changes
Periodo de tiempo: One year
|
Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine
|
One year
|
|
Biomarkers
Periodo de tiempo: One year
|
Trends in HF-specific biomarkers: NT-proBNP, ST2
|
One year
|
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Respiration Patterns
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Maria Patarroyo-Aponte, MD, West Penn Allegheny Health System
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de diciembre de 2015
Finalización primaria (Actual)
2 de junio de 2016
Finalización del estudio (Actual)
1 de julio de 2016
Fechas de registro del estudio
Enviado por primera vez
20 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
3 de diciembre de 2015
Publicado por primera vez (Estimar)
8 de diciembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
20 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AGH-11-15-01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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