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Pulmonary Hypertension, Quality of Life and Psychosocial Factors (HyPsy)

30. august 2021 opdateret af: University Hospital, Montpellier

Pulmonary Hypertension: Impact of the Evolution of a Rare Disease on the Quality of Life and Role of Variables Psychosocial as Predictive of the Current and Later Quality of Life

The investigators aim to :

  • describe and analyse psychological characteristics, cognitive factors and representations in patients with Pulmonary Hypertension, a rare disease.
  • assess the psychological characteristics impact on quality of life, check the association between disease and QoL evolution, and the variability of QoL parameters over severity class changes and follow-up

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PAH is a rare, and severe disease, potentially mortal, affecting preferentially young subjects. The knowledge and the international literature, as regards the quality of life, the expectations, the needs and the psychosocial characteristics of patients with PAH, are non-existent. But it is known that the persons affected by rare diseases are more vulnerable, on the psychological, social, economic and cultural planIn all the stages of the treatment, patients with PAH are confronted with heavy psychosocial situations, in a context of vital risk, with exceptional medicinal treatments (intravenous administration at home).

  • QoL might be differently affected by these changes according to situational and dispositional psychological dimensions.
  • the predictive role of these characteristics on the current and later quality of life, as well as the impact of diverse cognitive mediators and strategies to cope with the disease, should be investigated.The respiratory diseases department of the Montpellier hospital is regional competence center for PAH in Languedoc-Roussillon, under the aegis of the national reference center (the respiratory diseases department of Antoine Béclère hospital, Le Petit-Clamart).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

55

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Montpellier, Frankrig, 34295
        • CHU

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with PAH, aged between 18 and 80 years, stable since 3 months, no psychological follow-up at the competence center.

Beskrivelse

Inclusion Criteria:

  • Patients with PAH
  • Patients stable since 3 months
  • Patients with a severity of class I to IV
  • Patients aged between 18 and 80 years
  • Patients no psychological follow-up at the competence center.

Exclusion Criteria:

  • Patients unable to give his accordance
  • Patients unable to understand the aim of the study
  • Patients with recents psychiatrics disorders
  • Patients with problems of understanding the tests of the study
  • Drug users or drinkers
  • Pregnant or women without efficacy contraception
  • Patient without freedom by administration decision
  • Patient in exclusion period
  • Patient without french insurance
  • Adult protected by the law

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
Intervention / Behandling
patients with pulmonary hypertension
Adfærdsmæssigt: Evaluation of quality of life
-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Descriptive analysis of psychological characteristics on PAH patients
Tidsramme: 36 months
The descriptive analysis of psychological characteristics (anxiety, depression, social support, coping, control beliefs) is evaluated at entry and at one year. These psychological characteristics are evaluated by score of psychological questionnaires.
36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychological characteristics impact on Quality of life
Tidsramme: 36 months
The quality of life is measured by the score of the SF 36, the stage of the disease is codified by the NYHA, Qualitative and quantitative analysis of contents of the audio bands by the psychologist implicated to this study.
36 months
Association between disease and Quality of life evolution
Tidsramme: 36 months
The quality of life is measured by the score of the SF 36, the stage of the disease is codified by the NYHA, Qualitative and quantitative analysis of contents of the audio bands by the psychologist implicated to this study.
36 months
Variability of Quality of life parameters over severity class changes and follow-up
Tidsramme: 36 months
The quality of life is measured by the score of the SF 36, the stage of the disease is codified by the NYHA, Qualitative and quantitative analysis of contents of the audio bands by the psychologist implicated to this study.
36 months

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Montpellier

Samarbejdspartnere

GlaxoSmithKline

Efterforskere

  • Studieleder: Bourdin Arnaud, MD, PhD, University Hospital, Montpellier

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.

Generelle publikationer

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)

31. maj 2011

Primær færdiggørelse (Faktiske)

20. maj 2016

Studieafslutning (Faktiske)

20. maj 2016

Datoer for studieregistrering

Først indsendt

6. juni 2011

Først indsendt, der opfyldte QC-kriterier

23. juni 2011

Først opslået (Skøn)

27. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. august 2021

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8705
  • 2011-A00174-37 (Anden identifikator: AFSSAPS)

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 .

Kliniske forsøg med Pulmonal hypertension

Kliniske forsøg med Evaluation of quality of life

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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