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Determine Return on Investment in Heart Failure Remote Monitoring Program

29 de marzo de 2016 actualizado por: NCH Heatlhcare System Inc

A Prospective Randomized Controlled Trial to Determine Return on Investment in a Tablet/Smartphone-based Heart Failure Remote Monitoring Program

The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).

Descripción general del estudio

Estado

Desconocido

Descripción detallada

The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

163

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

    • Florida
      • Naples, Florida, Estados Unidos, 34102
        • Reclutamiento
        • NCH Healthcare System
        • Contacto:
        • Contacto:

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 89 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Absence of significant vision, hearing, or other communication deficits
  • English speaking;
  • Capable and willing to give informed consent;
  • Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
  • Living in a private home;
  • Hospital admission for Heart Failure or decompensation in the previous 12 months
  • New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
  • Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
  • Left ventricular ejection fraction <40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.

or

  • NYHA class II-III who had an ejection fraction >40% and evidence of diastolic left ventricular dysfunction.
  • Optional subject with a diagnosis of diabetes (indicated by HbA1c >7).

Exclusion Criteria:

  • Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
  • Females who are pregnant, planning to become pregnant within 3 months, or lactating;
  • Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
  • Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
  • End-stage heart failure requiring regular inotropic drug infusions;
  • Chronic renal failure requiring dialysis treatment and
  • Unstable angina.

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Control
Control: Peripherals with HealthInterlink technology will record and transmit data, without intervention. Subject is able to view graphed data, bring the HealthInterlink tablet/smartphone to the physician's office and share data with family/other caregiver.
home remote monitoring
Otros nombres:
  • Escala de peso
  • Welch Allyn
  • Blood Pressure monitor
  • Oxímetro de pulso
  • tablet/smartphone-based technology
Experimental: Intervention 1
Intervention 1: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver.
home remote monitoring
Otros nombres:
  • Escala de peso
  • Welch Allyn
  • Blood Pressure monitor
  • Oxímetro de pulso
  • tablet/smartphone-based technology
Experimental: Intervention 2
Intervention 2: Peripherals with HealthInterlink technology will record and transmit data and send out-of-range data (Red) alerts to subject via HealthInterlink tablet/smartphone and also text/email to family/other caregiver, and nonconformity (Blue) alerts to subject's personal text/email and also text/email to family/other caregiver, and a call will be placed by the nurse research assistant to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts). The physicians will have access to the subject's data on a web-based program.
home remote monitoring
Otros nombres:
  • Escala de peso
  • Welch Allyn
  • Blood Pressure monitor
  • Oxímetro de pulso
  • tablet/smartphone-based technology

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of subjects with unplanned re- hospitalization (heart failure-related and other hospitalization)
Periodo de tiempo: 31 days
31 days post discharge with a heart failure-related hospital re-hospitalization.
31 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Communication with healthcare provider or emergency department
Periodo de tiempo: 31 days
Communication that resulted in unplanned healthcare provider office visits or visit to emergency department
31 days
Number of non-conformity issues
Periodo de tiempo: 31 days
Number of non-conformity telephone reminder texts, emails, and/or calls.
31 days
Health-related quality of life Questionnaire
Periodo de tiempo: 31 days
Health-related quality of life
31 days
Subject satisfaction Questionnaire
Periodo de tiempo: 31 days
Subject satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use, time to complete testing and questionnaire, benefit that promoted better health
31 days
Physician satisfaction Questionnaire
Periodo de tiempo: 31 days
Physician satisfaction for peripherals and HealthInterlink tablet/ smartphone judged to be reliable and robust, ease of use of software, benefit that promoted better communication with subject.
31 days
Cost of system and intervention per subjects
Periodo de tiempo: 31 days
Economic viability of remote monitoring program based on daily cost of system and intervention per subjects in comparison with control and treatment groups.
31 days

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number and type of incidents
Periodo de tiempo: 31 days
Number and type of incident based on predefined criteria from the remote monitoring data (clinical signs and symptoms related to worsening of cardiac insufficiency or to its complications).
31 days
Subject attrition
Periodo de tiempo: 31 days
Rate of subjects discontinuing the study due to Patient Request, Patient Complaint, Patient Transferred to higher level of care (ACLF, SNF), Patient Hospitalized, Physician Request Monitoring No Longer Needed (Resolution of Disease Process, Change in Treatment), Physician Complaint, Patient Expired, Patient all-cause mortality or Without other identifiable cause.
31 days

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Theresa Morrison, PhD, NCH Healthcare System Inc

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 junio de 2015

Finalización primaria (Anticipado)

1 de junio de 2017

Finalización del estudio (Anticipado)

1 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

12 de junio de 2015

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2015

Publicado por primera vez (Estimar)

18 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

31 de marzo de 2016

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

29 de marzo de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 15-001

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. .

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