NCT01380054

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2016

Completed
Last Updated

September 5, 2021

Status Verified

January 1, 2018

Enrollment Period

5 years

First QC Date

June 6, 2011

Last Update Submit

August 30, 2021

Conditions

Pulmonary Hypertension

Keywords

Pulmonary HypertensionQuality of lifeCopingDepressionAnxietySocial supportControl beliefs

Outcome Measures

Primary Outcomes (1)

  • Descriptive analysis of psychological characteristics on PAH patients

    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.

    36 months

Secondary Outcomes (3)

  • Psychological characteristics impact on Quality of life

    36 months

  • Association between disease and Quality of life evolution

    36 months

  • Variability of Quality of life parameters over severity class changes and follow-up

    36 months

Study Arms (1)

patients with pulmonary hypertension

Behavioral: Evaluation of quality of life

Interventions

Evaluation of quality of lifeBEHAVIORAL

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

patients with pulmonary hypertension

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with PAH, aged between 18 and 80 years, stable since 3 months, no psychological follow-up at the competence center.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 without french insurance
  • Adult protected by the law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Montpellier, 34295, France

Location

Related Publications (2)

  • 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.

    PMID: 34435036RESULT

  • 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.

    PMID: 29332633RESULT

Related Links

MeSH Terms

Conditions

Hypertension, PulmonaryDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Bourdin Arnaud, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2011

First Posted

June 27, 2011

Study Start

May 31, 2011

Primary Completion

May 20, 2016

Study Completion

May 20, 2016

Last Updated

September 5, 2021

Record last verified: 2018-01

Locations

FR(1)