Pulmonary HypertensionHyPsyNCT01380054
Pulmonary Hypertension, Quality of Life and Psychosocial Factors
An observational study of Pulmonary Hypertension, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Evaluation of quality of life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2011to 20 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PAH, aged between 18 and 80 years, stable since 3 months, no psychological follow-up at the competence center.
Who may be able to join
- 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.
Who cannot join
- 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
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- Patient without freedom by administration decision
- Patient in exclusion period
- Patient without french insurance
- Adult protected by the law
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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).
- Conditions
- Pulmonary Hypertension
- Being tested
- Evaluation of quality of life
- Keywords
- Pulmonary Hypertension, Quality of life, Coping, Depression, Anxiety, Social support, Control beliefs
- Medical subject headings
- Hypertension, Pulmonary, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of quality of lifeBehavioural
-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36
| Study group | Role | What they receive |
|---|---|---|
| patients with pulmonary hypertension | Not described Receives: Behavioral: Evaluation of quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
Psychological characteristics impact on Quality of life
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.
Measured: 36 months
Association between disease and Quality of life evolution
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.
Measured: 36 months
Variability of Quality of life parameters over severity class changes and follow-up
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start31 May 2011
- Primary completion20 May 2016
- Study completion20 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Bourdin Arnaud, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380054
- Sponsor's protocol ID
- 8705
- Other IDs
- 2011-A00174-37
- Acronym
- HyPsy
- Status last verified
- Jan 2018
- First submitted
- 6 Jun 2011
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34435036Halimi 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.
PubMed 29332633
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01380054
- Acronym / sponsor ID
- HyPsy / 8705
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Quality of life, Coping, Depression, Anxiety, Social support, Control beliefs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 31 May 2011 (actual)
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 20 May 2016 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with pulmonary hypertension | – | Behavioral: Evaluation of quality of life |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PAH, aged between 18 and 80 years, stable since 3 months, no psychological follow-up at the competence center.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of quality of life-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36 | Behavioural | patients with pulmonary hypertension |
Primary outcome
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.
3 secondary outcomes
Psychological characteristics impact on Quality of life
Time frame: 36 months
Association between disease and Quality of life evolution
Time frame: 36 months
Variability of Quality of life parameters over severity class changes and follow-up
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Results publication: PubMed 34435036Halimi 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.
- Results publication: PubMed 29332633Halimi 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.
- HyPsy on the Open Science Framework.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bourdin Arnaud, MD, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of psychological characteristics on PAH patients (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.