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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Behavioral: Evaluation of quality of life

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).

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with pulmonary hypertension	Behavioral: Evaluation of quality of life; -Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: GlaxoSmithKline
• Investigators: Study Director: Bourdin Arnaud, MD, PhD, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• HyPsy on the Open Science Framework.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2011
• Primary Completion (Actual): May 20, 2016
• Study Completion (Actual): May 20, 2016

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Quality of life; Pulmonary Hypertension; Coping; Social support; Control beliefs
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 8705; 2011-A00174-37 (Other Identifier: AFSSAPS)