Clinical trial NCT01380054: Pulmonary Hypertension, Quality of Life and Psychosocial Factors
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Quality of life
Coping
Depression
Anxiety
Social support
Control beliefs
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-06-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with PAH, aged between 18 and 80 years, stable since 3 months, no psychological follow-up at the competence center.

Brief summary: 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

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Descriptive analysis of psychological characteristics on PAH patients
timeFrame: 36 months
Secondary outcomes:
measure: Psychological characteristics impact on Quality of life
timeFrame: 36 months
measure: Association between disease and Quality of life evolution
timeFrame: 36 months
measure: Variability of Quality of life parameters over severity class changes and follow-up
timeFrame: 36 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Montpellier
name: Bourdin Arnaud, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Halimi L, Suehs CM, Marin G, Boissin C, Gamez AS, Vachier I, Molinari N, Bourdin A. Health-related quality of life and disease progression in pulmonary arterial hypertension patients: a 3-year study. ERJ Open Res. 2021 Aug 23;7(3):00617-2020. doi: 10.1183/23120541.00617-2020. eCollection 2021 Jul.
citation: Halimi L, Marin G, Molinari N, Gamez AS, Boissin C, Suehs CM, Vachier I, Bourdin A. Impact of psychological factors on the health-related quality of life of patients treated for pulmonary arterial hypertension. J Psychosom Res. 2018 Feb;105:45-51. doi: 10.1016/j.jpsychores.2017.12.003. Epub 2017 Dec 6.