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Completed

NCT Number: NCT01380054

Pulmonary Hypertension, Quality of Life and Psychosocial Factors

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU

Montpellier, 34295, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of quality of life

Behavioral

-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36

Primary outcomes

  1. Descriptive analysis of psychological characteristics on PAH patients

    Time frame: 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.

Secondary outcomes

  1. Psychological characteristics impact on Quality of life

    Time frame: 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.

  2. Association between disease and Quality of life evolution

    Time frame: 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.

  3. Variability of Quality of life parameters over severity class changes and follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: HyPsy

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 27, 2011
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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