- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01495780
eRT Remote Health Monitoring
Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).
Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Los Angeles, California, Estados Unidos, 90095
- UCLA David Geffen School of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age >40 years.
- Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9
- Smoking history >10 pack-years.
- Postbronchodilator FEV1/FVC<70% and FEV1<70% based on NHANES III reference values
- Domestic situation felt to be supportive of remote health monitoring.
- Ability to give informed consent.
Exclusion Criteria:
- Clinical diagnosis of asthma.
- Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction.
- Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke).
- Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit.
- Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial.
- Myocardial infarction within 6 weeks of enrolment.
- Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day.
- A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Remote Health Monitoring
Subjects assigned to this arm will conduct daily at-home health monitoring using several electronic devices that will transmit data back to the study team.
Everyday, subjects will measure pulse oximetry (SpO2) using a finger clip, answer questions about symptoms and medication use, answer a quality of life questionnaire, perform breathing tests, and record physical activity (using a physical activity monitor that will be mailed to the study team).
Wearing the activity monitor is optional and will only occur during months 1, 6, and 12.
|
1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Compliance with daily RHM
Periodo de tiempo: 1 year
|
Compliance with daily RHM as a percentage of study days
|
1 year
|
|
Integrity of spirometric data
Periodo de tiempo: 1 year
|
Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Número de visitas al médico
Periodo de tiempo: 1 año
|
1 año
|
|
|
Rate of adoption of RHM
Periodo de tiempo: 1 year
|
Time it takes for subjects to become compliant with daily RHM
|
1 year
|
|
Treatment adherence
Periodo de tiempo: 1 year
|
Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)
|
1 year
|
|
Time to first COPD exacerbation
Periodo de tiempo: 1 year
|
Time to first COPD exacerbation as defined by standard criteria.
|
1 year
|
|
Number of COPD exacerbations per year
Periodo de tiempo: 1 year
|
1 year
|
|
|
Proportion of subjects experiencing one or more exacerbations
Periodo de tiempo: 1 year
|
1 year
|
|
|
Mean daily FEV1
Periodo de tiempo: 1 year
|
1 year
|
|
|
Mean daily IC
Periodo de tiempo: 1 year
|
1 year
|
|
|
Mean daily activity level
Periodo de tiempo: 1 year
|
1 year
|
|
|
Mean daily SpO2
Periodo de tiempo: 1 year
|
1 year
|
|
|
Daily symptom scores
Periodo de tiempo: 1 year
|
1 year
|
|
|
Number of emergency department visits
Periodo de tiempo: 1 year
|
1 year
|
|
|
Number of hospitalizations
Periodo de tiempo: 1 year
|
1 year
|
|
|
Number of days spent in hospital
Periodo de tiempo: 1 year
|
1 year
|
|
|
Health care costs
Periodo de tiempo: 1 year
|
Inferred health care costs using a standard cost framework model
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- eRT RHM
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .