Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.
At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning. The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Idiopathic Pulmonary Fibrosis (IPF) is a disease of aging associated with intense medical and financial burden and expected to grow in incidence within the US population. Median survival from diagnosis is 3.8 years, although some patients succumb to a rapid death within 6 months. New therapies have recently become available. While these medications slow the rate of pulmonary deterioration, they have no impact on ultimate survival or quality of life. Although transplantation is an effective surgical therapy, less than 20% of patients ever receive a lung transplant. The remaining 80% have few treatment options and a likely rapidly progressive downhill course. Despite the fatal prognosis, we have found that patients and caregivers often fail to understand the poor prognosis as the disease relentlessly progresses. At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning.
The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention. Patients with IPF and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 45 years or older
- Primary Diagnosis of with Idiopathic Pulmonary Fibrosis (IPF)
- Has a caregiver, 18 years or older (spouse/partner/child/family member/friend), willing to participate.
- Sees a Simmons Center Physician for usual IPF care.
Exclusion Criteria:
- less than 45 years
- Not diagnosed with IPF
- Has an unwilling caregiver, or a caregiver under 18.
- Does not see a Simmons Center Physician for usual IPF care.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Intervention
Group will receive SUPPORT, an intervention that provides information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, and digitally (via use of a tablet) delivered by an interventionist.
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Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.
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Otro: Usual Care
Group will receive usual standard-of-care, and be provided with currently available printed material for information about their illness.
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Subjects will receive their usual standard of care, including currently available printed patient material.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stress
Periodo de tiempo: 3 years
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Perceived Stress Scale at baseline and completion of study in patients and caregivers
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3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease Preparedness
Periodo de tiempo: 3 years
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Survey to measure preparation for disease course at completion of study for patients and caregivers.
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3 years
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Knowledge
Periodo de tiempo: 3 years
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Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers
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3 years
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Advance Care Planning
Periodo de tiempo: 3 years
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Survey to measure completion of advance care plan at study completion with patients
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3 years
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Quality of Dying and Death
Periodo de tiempo: 3 years
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Quality of Dying and Death for caregivers if patient deceased during study
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3 years
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Symptom Burden
Periodo de tiempo: 3 years
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Promis-29 to measure symptom burden in patients at baseline and study completion.
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3 years
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Health Related Quality of Life in IPF
Periodo de tiempo: 3 years
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ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.
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3 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kathleen O Lindell, PhD, RN, Dorothy P. and Richard P. Simmons Center for ILD
Publicaciones y enlaces útiles
Publicaciones Generales
- Lindell KO, Klein SJ, Veatch MS, Gibson KF, Kass DJ, Nouraie M, Rosenzweig MQ. Nurse-Led Palliative Care Clinical Trial Improves Knowledge and Preparedness in Caregivers of Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Nov;18(11):1811-1821. doi: 10.1513/AnnalsATS.202012-1494OC.
- Lindell KO, Nouraie M, Klesen MJ, Klein S, Gibson KF, Kass DJ, Rosenzweig MQ. Randomised clinical trial of an early palliative care intervention (SUPPORT) for patients with idiopathic pulmonary fibrosis (IPF) and their caregivers: protocol and key design considerations. BMJ Open Respir Res. 2018 Feb 19;5(1):e000272. doi: 10.1136/bmjresp-2017-000272. eCollection 2018.
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
- PRO16070539
- 1K23NR016276-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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