Pulmonary Hypertension, Quality of Life and Psychosocial Factors

Pulmonary Hypertension Clinical Trial

— HyPsy  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380054
• Other study ID #: 8705
• Secondary ID: 2011-A00174-37
• Status: Completed
• Start date: May 31, 2011
• Est. completion date: May 20, 2016

Study information

• Verified date: January 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 20, 2016
• Est. primary completion date: May 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
France	CHU	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	GlaxoSmithKline

Country where clinical trial is conducted

France, 

References & Publications (2)

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 — View 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). pii: 00617-2020. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive analysis of psychological characteristics on PAH patients	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
Secondary	Psychological characteristics impact on Quality of life	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
Secondary	Association between disease and Quality of life evolution	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
Secondary	Variability of Quality of life parameters over severity class changes and follow-up	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

External Links

•   HyPsy on the Open Science Framework.