Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Emotional and Social Experiences of Antifibrotic (AF) Therapy Among Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF) Patients: A Real-World Study

10. august 2026 opdateret af: Boehringer Ingelheim

A Real-World Study of the Perceived Emotional and Social Experiences Related to Antifibrotic Therapy in Patients With IPF and PPF: A Cross-Sectional Web-Based Survey

This is a cross-sectional study that will be conducted across Japan using an online patient-reported outcome questionnaire.

This study tries to find out the attitudes toward and experiences of the emotional and/or social impact of side effects associated with antifibrotic (AF) treatment among Japanese patients with Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF), and how are these attitudes associated with patients' individual characteristics.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Japan
      • Tokyo, Japan, 141-6017
        • Rekruttering
        • Nippon Boehringer Ingelheim Co., Ltd.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The study population will consist of patients with IPF and PPF who meet the inclusion criteria and do not meet any exclusion criteria (outlined below), and have provided informed consent to participate in the study using an electronic informed consent form (eICF).

Beskrivelse

Inclusion Criteria:

  1. Patients with IPF aged 40 years or older who received nintedanib or pirfenidone within the previous 4 weeks, or patients with PPF aged 18 years or older who received nintedanib within the previous 4 weeks
  2. Patients capable of responding to a self-administered questionnaire

Exclusion Criteria:

  1. Patients treated with nerandomilast (including clinical trials)
  2. Patients with PPF treated with pirfenidone
  3. Patients currently hospitalized
  4. Patients with malignant tumors

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Japanese patients with IPF/PPF

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The score of patient experiences and satisfaction with medications (PESaM) side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.
Assessed once at survey completion (approximately 20 minutes after survey initiation).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Mean (95% CI) scores for the EQ-5D-5L
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The quality of life (Qol) 5 dimensions 5-level (EQ-5D-5L) index score ranges from less than 0 (states valued as worse than death, with a minimum of -0.025 based on the Japanese tariff) to 1 (perfect health). Higher scores indicate a better health-related quality of life.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Mean (95% CI) scores for the SDM-Q-9
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).
The 9-Item Shared Decision-Making Questionnaire (SDM-Q-9) score is derived as a sum of the nine items, each rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree) and it ranges from 0 to 45. A higher score indicates a greater degree of patient involvement in the shared decision-making process (reflecting better shared decision-making).
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Reliability (Cronbach's α) of PESaM side effects sub-domain
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).
To evaluate the reliability of the PESaM side effects sub-domain, Cronbach's alpha will be calculated.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Validity (correlation with EQ-5D-5L) of PESaM side effects sub-domain
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

EQ-5D-5L index score ranges from less than 0 (states valued as worse than death, with a minimum of -0.025 based on the Japanese tariff) to 1 (perfect health). Higher scores indicate a better health-related quality of life.
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Correlation between PESaM side effects sub-domain and SDM-Q-9
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

The 9-Item SDM-Q-9 score is derived as a sum of the nine items, each rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree) and it ranges from 0 to 45. A higher score indicates a greater degree of patient involvement in the shared decision-making process (reflecting better shared decision-making).
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Descriptive statistics of patient background in high- and low-score groups for the PESaM side effects sub-domain
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

The following descriptive statistics will be reported:

  • Sex
  • Age
Assessed once at survey completion (approximately 20 minutes after survey initiation).
Clinical characteristics in high- and low-score groups for the PESaM side effects sub-domain
Tidsramme: Assessed once at survey completion (approximately 20 minutes after survey initiation).

The score of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.

The following clinical characteristics will be reported:

  • Lung diseases group
  • AF treatment in use
  • Disease duration
  • Severity/use of oxygen therapy
Assessed once at survey completion (approximately 20 minutes after survey initiation).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

24. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. august 2026

Først opslået (Faktiske)

4. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1305-0170

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD-delingsadgangskriterier

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner