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Pulmonary Hypertension, Quality of Life and Psychosocial Factors

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01380054
Acronym
HyPsy
Enrollment
55
Registered
2011-06-27
Start date
2011-05-31
Completion date
2016-05-20
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension, Quality of life, Coping, Depression, Anxiety, Social support, Control beliefs

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).

Interventions

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

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Descriptive analysis of psychological characteristics on PAH patients36 monthsThe 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

MeasureTime frameDescription
Psychological characteristics impact on Quality of life36 monthsThe 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.
Association between disease and Quality of life evolution36 monthsThe 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.
Variability of Quality of life parameters over severity class changes and follow-up36 monthsThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026