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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380054
First Posted: June 27, 2011
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose

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 Intervention
Pulmonary Hypertension Behavioral: Evaluation of quality of life

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.


Enrollment: 55
Actual Study Start Date: May 31, 2011
Study Completion Date: May 20, 2016
Primary Completion Date: May 20, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380054


Locations
France
CHU
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
GlaxoSmithKline
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01380054     History of Changes
Other Study ID Numbers: 8705
2011-A00174-37 ( Other Identifier: AFSSAPS )
First Submitted: June 6, 2011
First Posted: June 27, 2011
Last Update Posted: April 17, 2017
Last Verified: April 2017

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