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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15213
- Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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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Autre: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Stress
Délai: 3 years
|
Perceived Stress Scale at baseline and completion of study in patients and caregivers
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3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Disease Preparedness
Délai: 3 years
|
Survey to measure preparation for disease course at completion of study for patients and caregivers.
|
3 years
|
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Knowledge
Délai: 3 years
|
Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers
|
3 years
|
|
Advance Care Planning
Délai: 3 years
|
Survey to measure completion of advance care plan at study completion with patients
|
3 years
|
|
Quality of Dying and Death
Délai: 3 years
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Quality of Dying and Death for caregivers if patient deceased during study
|
3 years
|
|
Symptom Burden
Délai: 3 years
|
Promis-29 to measure symptom burden in patients at baseline and study completion.
|
3 years
|
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Health Related Quality of Life in IPF
Délai: 3 years
|
ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.
|
3 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kathleen O Lindell, PhD, RN, Dorothy P. and Richard P. Simmons Center for ILD
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PRO16070539
- 1K23NR016276-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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