HemophiliaM-HEMORRH'AGENCT04282486
Medication Exposure in Older Patients With Constitutional Hemorrhagic Disease
An observational study of Hemophilia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The improvements observed in the care of patients with hemophilia or Willebrand disease have led to an increase in their life expectancy, which today approaches that of the general population. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Hemophilia
- What is being tested?
- Telephone interview
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2020to 29 Jan 2021
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Elderly patients with hemophilia or Willebrand's disease (over 65) will have a telephone interview in order to collect medication data from medical prescriptions.
Who may be able to join
- Community-dwelling patients over 65 years with hemophilia (A or B)
- Community-dwelling patients over 65 years with Willebrand disease (Type1, 2 and 3, rate <30%)
Who cannot join
- Patients without phone number
- Non French speaking patients
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital des Charpennes, Institut du Vieillissement
Villeurbanne, 69100
About this study
Official title: Medication Exposure in Older Patients (AGEd > 65 Years) With Constitutional HEMORRHagic Disease (Haemophilia or Willebrand Disease).
The improvements observed in the care of patients with hemophilia or Willebrand disease have led to an increase in their life expectancy, which today approaches that of the general population. This increase in life expectancy leads in these patients to the development of comorbidities related to aging (cardiovascular and neurological diseases, cancers and kidney diseases) (e.g "Franchini \& Mannuccio", BJH, 2009). The care of these comorbidities represents a new challenge for the medical teams. Toward multiple comorbidities, polypharmacy is often associated.
Many studies about medication exposure and management in older patients were published but no study was conducted to explore the medication management of older patients with hemophilia or Willebrand disease.
- Conditions
- Hemophilia
- Being tested
- Telephone interview
- Keywords
- Willebrand disease
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interviewOther
Primary objective: potentially inappropriate medication prevalence
Secondary objective:
Number and type of medication Polypharmacy prevalence Medication regimen complexity using Medication Regimen Complexity Index Anticholinergic and sedative exposure using Drug Burden Index
A telephone interview will be conducted with patients in order to collect medication data from medical prescriptions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Potentially inappropriate medication (PIM) prevalence using EU-(7) PIM list.
A telephone interview will be conducted with patients in order to collect medication data from medical prescriptions. After collection of data for all patients, the research of PIM was conducted.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start22 Jul 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282486
- Sponsor's protocol ID
- 69HCL20_0086
- Acronym
- M-HEMORRH'AGE
- Status last verified
- Jul 2021
- First submitted
- 21 Feb 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Exposure in Older Patients (AGEd > 65 Years) With Constitutional HEMORRHagic Disease (Haemophilia or Willebrand Disease).
- ClinicalTrials.gov ID
- NCT04282486
- Acronym / sponsor ID
- M-HEMORRH'AGE / 69HCL20_0086
- Conditions
- Hemophilia
- Keywords
- Willebrand disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 24 Feb 2020 (actual)
- 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 improvements observed in the care of patients with hemophilia or Willebrand disease have led to an increase in their life expectancy, which today approaches that of the general population. This increase in life expectancy leads in these patients to the development of comorbidities related to aging (cardiovascular and neurological diseases, cancers and kidney diseases) (e.g "Franchini \& Mannuccio", BJH, 2009). The care of these comorbidities represents a new challenge for the medical teams. Toward multiple comorbidities, polypharmacy is often associated.
Many studies about medication exposure and management in older patients were published but no study was conducted to explore the medication management of older patients with hemophilia or Willebrand disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elderly patients with hemophilia or Willebrand's disease (over 65) will have a telephone interview in order to collect medication data from medical prescriptions.
Key inclusion criteria (2 listed)
- Community-dwelling patients over 65 years with hemophilia (A or B)
- Community-dwelling patients over 65 years with Willebrand disease (Type1, 2 and 3, rate <30%)
Key exclusion criteria (2 listed)
- Patients without phone number
- Non French speaking patients
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 |
|---|---|---|
| Telephone interviewPrimary objective: potentially inappropriate medication prevalence Secondary objective: Number and type of medication Polypharmacy prevalence Medication regimen complexity using Medication Regimen Complexity Index Anticholinergic and sedative exposure using Drug Burden Index A telephone interview will be conducted with patients in order to collect medication data from medical prescriptions. | Other | – |
Primary outcome
Potentially inappropriate medication (PIM) prevalence using EU-(7) PIM list.
Time frame: At inclusion
A telephone interview will be conducted with patients in order to collect medication data from medical prescriptions. After collection of data for all patients, the research of PIM was conducted.
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 13 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemophilia, run by Hospices Civils de Lyon 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 2 inclusion and 2 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 13 Jul 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?
Potentially inappropriate medication (PIM) prevalence using EU-(7) PIM list. (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2021.