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Heart at Home- a Self-care Study

15 de septiembre de 2014 actualizado por: VTT Technical Research Centre of Finland

Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients

In the study benefits of using mobile phone assisted remote patient monitoring including self-measurements of blood pressure, heart rate and weight as well as monitoring of personal health status are investigated in the care of heart failure patients.

Descripción general del estudio

Estado

Terminado

Tipo de estudio

Intervencionista

Inscripción (Actual)

94

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

      • Espoo, Finlandia
        • VTT Technical Research Centre of Finland

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 a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • diagnosis of systolic heart failure
  • NYHA (New York Heart Association) classification > 1
  • left ventricular ejection fraction ≤ 35%
  • need for a regular control visit
  • time from the last visit no longer than 6 months

Exclusion Criteria:

  • Patients who were known to enter a major medical operation
  • severe comorbidity,
  • participation in other clinical trial during last three months-
  • poor compliance in terms of familiarity with mobile phone

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Telemonitoring assisted self-care
Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring
Sin intervención: Control group
Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of heart failure (HF) patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of HF-related Hospital Days
Periodo de tiempo: From baseline until the end of the study at six months
Number of heart failure related hospital days
From baseline until the end of the study at six months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Death
Periodo de tiempo: From baseline until the end of the study at six months
Death from any cause
From baseline until the end of the study at six months
Heart Transplant
Periodo de tiempo: From baseline until the end of the study at six months
Heart transplant operation or listing for transplant operation
From baseline until the end of the study at six months
P-proBNP
Periodo de tiempo: From baseline until the end of the study at six months
Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.
From baseline until the end of the study at six months
EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores
Periodo de tiempo: From baseline until the end of the study at six months
Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed.
From baseline until the end of the study at six months
Left Ventricular Ejection Fraction
Periodo de tiempo: From baseline until the end of the study at six months
Change in left ventricular ejection fraction from baseline until the end of the study
From baseline until the end of the study at six months
Utilization of Health Care Resources
Periodo de tiempo: From baseline until the end of the study at six months
Number of visits to nurse's reception
From baseline until the end of the study at six months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study
Periodo de tiempo: From baseline to the end of the study at six months
Change in plasma concentrations of creatinine, natrium, and potassium
From baseline to the end of the study at six months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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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 octubre de 2010

Finalización primaria (Actual)

1 de marzo de 2012

Finalización del estudio (Actual)

1 de junio de 2012

Fechas de registro del estudio

Enviado por primera vez

20 de diciembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

30 de diciembre de 2012

Publicado por primera vez (Estimar)

3 de enero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

17 de septiembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2014

Última verificación

1 de septiembre de 2014

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HUSHAH

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. .

Ensayos clínicos sobre Insuficiencia cardiaca

Ensayos clínicos sobre Telemonitoring assisted self-care

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