Pulmonary Hypertension, Quality of Life and Psychosocial Factors

NCT ID: NCT01380054

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with pulmonary hypertension

Evaluation of quality of life

Intervention Type BEHAVIORAL

-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation of quality of life

-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bourdin Arnaud, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Halimi L, Suehs CM, Marin G, Boissin C, Gamez AS, Vachier I, Molinari N, Bourdin A. Health-related quality of life and disease progression in pulmonary arterial hypertension patients: a 3-year study. ERJ Open Res. 2021 Aug 23;7(3):00617-2020. doi: 10.1183/23120541.00617-2020. eCollection 2021 Jul.

Reference Type RESULT
PMID: 34435036 (View on PubMed)

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.

Reference Type RESULT
PMID: 29332633 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://osf.io/8qduc

HyPsy on the Open Science Framework.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-A00174-37

Identifier Type: OTHER

Identifier Source: secondary_id

8705

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Behavioral Study to Control Blood Pressure
NCT01035554 COMPLETED PHASE2/PHASE3
Activity Monitoring in Pulmonary Hypertension
NCT04101630 ACTIVE_NOT_RECRUITING
Mobile Health Management of Hypertension
NCT05856955 NOT_YET_RECRUITING NA