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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment
Pulmonary Hypertension	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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	55 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
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
Actual Study Start Date :	May 31, 2011
Actual Primary Completion Date :	May 20, 2016
Actual Study Completion Date :	May 20, 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
CHU
Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

GlaxoSmithKline

Investigators

Study Director:	Bourdin Arnaud, MD, PhD	University Hospital, Montpellier

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

HyPsy on the Open Science Framework. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT01380054 History of Changes
Other Study ID Numbers:	8705; 2011-A00174-37 ( Other Identifier: AFSSAPS )
First Posted:	June 27, 2011
Last Update Posted:	January 5, 2018
Last Verified:	January 2018

Keywords provided by University Hospital, Montpellier:

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

Additional relevant MeSH terms:

Hypertension; Hypertension, Pulmonary; Vascular Diseases	Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases