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Pulmonary Hypertension, Quality of Life and Psychosocial Factors (HyPsy)
This study has been completed.
Sponsor:
University Hospital, Montpellier
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01380054
First received: June 6, 2011
Last updated: April 13, 2017
Last verified: April 2017
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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| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380054
Please refer to this study by its ClinicalTrials.gov identifier: 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 ) |
| Study First Received: | June 6, 2011 |
| Last Updated: | April 13, 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 |
ClinicalTrials.gov processed this record on June 21, 2017