Pulmonary Hypertension, Quality of Life and Psychosocial Factors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01380054
First received: June 6, 2011
Last updated: November 30, 2015
Last verified: November 2015

June 6, 2011
November 30, 2015
May 2011
May 2011   (final data collection date for primary outcome measure)
Descriptive analysis of psychological characteristics on PAH patients [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01380054 on ClinicalTrials.gov Archive Site
  • Psychological characteristics impact on Quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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

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

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).
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with PAH, aged between 18 and 80 years, stable since 3 months, no psychological follow-up at the competence center.
Pulmonary Hypertension
Behavioral: Evaluation of quality of life
-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36
patients with pulmonary hypertension
Intervention: Behavioral: Evaluation of quality of life
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
May 2016
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01380054
8705, 2011-A00174-37
No
Not Provided
Not Provided
University Hospital, Montpellier
University Hospital, Montpellier
GlaxoSmithKline
Not Provided
University Hospital, Montpellier
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP