Hypertension, PulmonaryETHAPNCT01038284
Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)
A study testing Patient education and Data collection in people with Hypertension, Pulmonary, run by University Hospital, Grenoble at 11 sites in France.
Trial summary
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Patient education and Data collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 11 sitesFrance
- Study dates
- Mar 2010to Feb 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18;
- Pulmonary arterial hypertension (NYHA II to IV);
- Any specific PAH treatment or oral anticoagulant.
Who cannot join
- Patients under 18 or protected by law;
- Patients who do not speak/understand French;
- Pregnancy;
- Patients enrolled in other clinical trials.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Bordeaux
Bordeaux
CHU Brest
Brest
Hopital Antoine Beclere
Clamart
Clinical Research Center Inserm CIC03 - Grenoble University Hospital
Grenoble, 38043
CHU Grenoble
Grenoble
CHU de Lille
Lille
CHU Nantes
Nantes
CHU de Nice
Nice
CHU Rouen
Rouen
CHU Strasbourg
Strasbourg
CHU Tours
Tours
About this study
Official title: Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.
This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.
The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Patient education, Data collection
- Keywords
- Patient Education, Drug Toxicity
- Medical subject headings
- Hypertension, Pulmonary, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
Pharmaceutical care of patients with PAH
Data collectionOther
Clinical and biological data, treatment, medication errors and ADEs
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Not described Receives: Other: Data collection |
| Patient education | Active comparator | Not described Receives: Behavioral: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication-related problems
Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions
Measured: 18 months
Secondary outcomes (1)
Patient Satisfaction with medication
Comparison between the SATMED-Q(R) score at 18 months between the two groups
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Roustit, PharmD, Study director, Clinical Research Center - Inserm CIC03, Grenoble, FrancePison Christophe, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038284
- Sponsor's protocol ID
- DCIC 09 12
- Acronym
- ETHAP
- Status last verified
- Mar 2014
- First submitted
- 22 Oct 2009
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21.
PubMed 32440738
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01038284
- Acronym / sponsor ID
- ETHAP / DCIC 09 12
- Conditions
- Hypertension, Pulmonary
- Keywords
- Patient Education, Drug Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Dec 2009 (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.
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.
This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.
The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Data collection |
| Patient education | Active comparator | Behavioral: Patient education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18;
- Pulmonary arterial hypertension (NYHA II to IV);
- Any specific PAH treatment or oral anticoagulant.
Key exclusion criteria (4 listed)
- Patients under 18 or protected by law;
- Patients who do not speak/understand French;
- Pregnancy;
- Patients enrolled in other clinical trials.
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 |
|---|---|---|
| Patient educationPharmaceutical care of patients with PAH | Behavioural | Patient education |
| Data collectionClinical and biological data, treatment, medication errors and ADEs | Other | Control |
Primary outcome
Medication-related problems
Time frame: 18 months
Medication errors (assessed by using the tool developped by the French Society for Clinical Pharmacy) and adverse drug reactions
1 secondary outcome
Patient Satisfaction with medication
Time frame: 18 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 17 Mar 2014.
- Derived from this study: PubMed 32440738Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21.
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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.
Matthieu Roustit, PharmD study director
Clinical Research Center - Inserm CIC03, Grenoble, France
Pison Christophe, MD, PhD principal investigator
University Hospital, Grenoble
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education and Data collection in people with Hypertension, Pulmonary, run by University Hospital, Grenoble at 11 sites 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 3 inclusion and 4 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 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. 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?
Medication-related problems (time frame: 18 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 NCT01038284, which also lists 1 linked publication.
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 17 Mar 2014.