HyPsy: Pulmonary Hypertension, Quality of Life and Psychosocial Factors

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT01380054

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

59.7

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Descriptive analysis of psychological characteristics on PAH patients [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

Psychological characteristics impact on Quality of life [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.
Association between disease and Quality of life evolution [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.
Variability of Quality of life parameters over severity class changes and follow-up [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.