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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02378571
Medication Adherence Telemonitoring to Reduce Heart Failure Readmissions (TEAM-HF)
18 de enero de 2018 actualizado por: Ian Kronish, Columbia University
Telemonitoring Adherence to Medications to Reduce Heart Failure Readmissions: A Pilot Randomized Clinical Trial
The overall purpose of this project is to determine the feasibility of conducting a large scale randomized clinical trial that compares remote monitoring of adherence to loop diuretics using a wireless electronic pillcap with usual care among recently hospitalized heart failure patients.
The long-term goal of this program of research is to determine the effect of the adherence telemonitoring intervention on medication adherence and hospital readmissions among recently hospitalized heart failure patients.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Approximately one in four patients hospitalized with heart failure is readmitted within 30 days of discharge and more than 50% are readmitted within 6 months of discharge.
Heart failure admissions are a major contributor to the enormous health care costs associated with heart failure.
Thus far, the identification of effective interventions that prevent unnecessary readmissions has remained elusive.
As a result, there is a pressing need to identify novel, cost-effective approaches to reducing heart failure readmissions.
A growing body of research suggests that poor adherence to heart failure medications is a major reason for preventable heart failure readmissions.
In particular, loop diuretic medications are essential to preventing the cardiopulmonary system from becoming overloaded.
Patients who have been recently hospitalized may be especially vulnerable to adherence problems as a result of the stress of the recent hospitalization which commonly induces sleep deprivation, nutritional deficiency, physical deconditioning, cognitive impairment, and even delirium.
Recent advances in wireless health now enable us to remotely, unobtrusively, and objectively monitor adherence to heart failure medications in the post-discharge period.
Early identification of non-adherence to loop diuretic medications has the prevention to prevent a volume overloaded state that leads to a heart failure readmission.
As patients who are non-adherent to their loop diuretics may also be non-adherent to other recommended self-management behaviors, early identification of medication nonadherence may provide the context to identify other gaps in self-management.
To test our hypothesis that it is feasible to conduct a randomized trial of wireless, medication adherence monitoring with feedback to patients and clinicians, the investigators will enroll 40 patients who are hospitalized for heart failure and discharged on a diuretic medication.
Patients will be randomized to 1) usual heart failure care + telemonitoring adherence to diuretic medications (INT); N=20 or 2) usual heart failure care (CTR); N=20.
All patients will be asked to take their diuretic medication from a standard pill bottle covered by an electronic pill cap (GlowCap), but only patients assigned to the intervention arm will have their adherence telemonitored by a study clinician in real-time.
Patients will have their adherence to medications measured in this fashion for 30 days after discharge.
Patients will be contacted at 30 days to determine if they have been hospitalized and to collect other self-reported outcomes data.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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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
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Hospitalized for heart failure
- Prescribed loop diuretic medication at discharge
Exclusion Criteria:
- Age less than 21 years
- New York Heart Association Class IV heart failure
- Terminal illness (<6 mo prognosis)
- Unable to self-administer medications due to mental illness or cognitive impairment
- Non-English/Spanish speaking
- Discharged to an institutional setting (e.g., nursing home)
- Cardiologist or primary care provider refusal
- Unavailable for follow-up
- No access to telephone
- Enrolled in another cardiac trial
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Usual care
Participants assigned to usual care will also be provided with a GlowCap prior to discharge and will be instructed to take their loop diuretic from this bottle and to notify the study team about prescribed dose changes.
This information, however, will solely be used to measure medication adherence and will not be provided to a member of the study team nor to any of the participants' health care providers until the completion of the study period, at least 1 month later.
Participants will not be provided with any advice on heart failure adherence.
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Experimental: Medication adherence telemonitoring
At discharge, participants in the intervention group will be instructed to take their loop diuretic exclusively from the GlowCap in the manner prescribed by their physician.
A study team member will review the adherence data on a daily basis (except holidays and weekends) during the first 7 days after discharge, and then on, at minimum, a weekly basis.
The study team member will respond to adherence data using clinical judgment as they would if the information was obtained during clinical care.
Specifically, when contacting nonadherent participants, the member of the study team will provide participants with feedback on their electronic adherence; will inquire about potential consequences of missed doses; and will assess and respond to reasons for missed doses.
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The member of the study team will respond to adherence data using clinical judgment as they would if the information was obtained during clinical care.
Specifically, when contacting nonadherent participants, the member of the study team will provide participants with feedback on their electronic adherence; will inquire about potential consequences of missed doses; and will assess and respond to reasons for missed doses.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of days participants take the correct number of doses of their diuretic
Periodo de tiempo: 30 days post-discharge
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Loop diuretic adherence: Adherence to the diuretic medication will be electronically measured using GlowCaps (Vitality Inc.) in the 30 days after hospitalization.
Medication adherence will be calculated as the percent of days participants take the correct number of doses of their diuretic.
Days when participants are incapable of taking their medication from the GlowCap bottle (e.g., while hospitalized) will be censored from calculations.
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30 days post-discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Score on the Self Care Heart Failure Index
Periodo de tiempo: 30 days post-discharge
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Heart Failure Symptoms, Self-Efficacy for self-managing heart failure, and Self-Management Behaviors will be measured using Self Care Heart Failure Index
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30 days post-discharge
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Proportion very or extremely satisfied with heart failure care
Periodo de tiempo: 30 days post-discharge
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Satisfaction with Heart Failure Care will be assessed by asking participants "Overall, how satisfied are you with the care you have been receiving for your heart problems over the last 30 days?" Response options will include: "not at all satisfied", "a little satisfied", "very satisfied," and "extremely satisfied."
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30 days post-discharge
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Number of readmissions and emergency room visits
Periodo de tiempo: 30 days post-discharge
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Readmissions and emergency room visits will be assessed by contacting participants or their close contacts at 30 days.
Hospital records will be reviewed to confirm readmissions, to determine the reason for readmission or emergency room visit (heart failure versus other), and to determine whether it was related to medication nonadherence.
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30 days post-discharge
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Proportion attending at least 1 scheduled outpatient clinic visit within 30 days of discharge
Periodo de tiempo: 30 days post-discharge
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Attendance at scheduled outpatient clinic visits will be assessed by contacting participants or their close contacts at 30 days.
Hospital records will be reviewed, when available, to determine whether and how medication adherence was addressed during the visit.
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30 days post-discharge
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ian M Kronish, MD, MPH, Columbia University
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 diciembre de 2014
Finalización primaria (Actual)
1 de octubre de 2015
Finalización del estudio (Actual)
1 de noviembre de 2015
Fechas de registro del estudio
Enviado por primera vez
27 de febrero de 2015
Primero enviado que cumplió con los criterios de control de calidad
3 de marzo de 2015
Publicado por primera vez (Estimar)
4 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de enero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de enero de 2018
Última verificación
1 de enero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAO3305
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
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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