Integrating Supportive Care in Cystic Fibrosis
17 février 2020 mis à jour par: Dio Kavalieratos, PhD, University of Pittsburgh
Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease.
Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF.
The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF.
The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care.
Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden.
This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
As described above.
Type d'étude
Interventionnel
Inscription (Réel)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Ability to comprehend English
- Advanced CF
(Any of the following criteria will be indicative of "Advanced CF")
- Baseline supplemental oxygen requirement
- FEV1 ≤ 50%
- Baseline non-invasive mechanical ventilation requirement
- ≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF
Exclusion Criteria:
- Prisoners
- Females who are pregnant
- Prior receipt of specialist SC services
- Cognitive impairments
- Patients younger than 18 years of age
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Usual Care
Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center.
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Expérimental: Supportive Care Intervention
Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.
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Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis.
Using a structured intervention manual, these visits will span 30-60 minutes each.
Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience.
Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of intervention
Délai: Up to 9 months (+/- 4 weeks)
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Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.
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Up to 9 months (+/- 4 weeks)
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Acceptability of intervention
Délai: Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse the intervention as acceptable.
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Up to 9 months (+/- 4 weeks)
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Perceived effectiveness of intervention
Délai: Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.
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Up to 9 months (+/- 4 weeks)
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Intervention fidelity
Délai: Up to 9 months (+/- 4 weeks)
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Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
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Up to 9 months (+/- 4 weeks)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Délai: Up to 9 months (+/- 4 weeks)
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Change in QOL from baseline as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Patient mood
Délai: Up to 9 months (+/- 4 weeks)
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Change in mood from baseline using the Hospital Anxiety and Depression Scale (HADS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Coping style
Délai: Up to 9 months (+/- 4 weeks)
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Change in coping style from baseline using the Brief COPE, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Satisfaction with care
Délai: Up to 9 months (+/- 4 weeks)
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Change in satisfaction with care from baseline using the FAMCARE-P13, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Symptom burden
Délai: Up to 9 months (+/- 4 weeks)
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Change in symptom burden from baseline using the Edmonton Symptom Assessment Scale (ESAS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Healthcare utilization
Délai: Up to 12 months
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The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.
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Up to 12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Dio Kavalieratos, PhD, Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh
- Chercheur principal: Joseph Pilewski, MD, Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 mars 2016
Achèvement primaire (Réel)
29 novembre 2018
Achèvement de l'étude (Réel)
7 octobre 2019
Dates d'inscription aux études
Première soumission
14 janvier 2016
Première soumission répondant aux critères de contrôle qualité
26 janvier 2016
Première publication (Estimation)
29 janvier 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 février 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 février 2020
Dernière vérification
1 février 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB#: PRO14110168
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis.
This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .