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Medication Exposure in Older Patients With Constitutional Hemorrhagic Disease (M-HEMORRH'AGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282486
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.


Condition or disease Intervention/treatment
Hemophilia Other: Telephone interview

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Medication Exposure in Older Patients (AGEd > 65 Years) With Constitutional HEMORRHagic Disease (Haemophilia or Willebrand Disease).
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding


Intervention Details:
  • Other: Telephone interview

    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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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%)

Exclusion Criteria:

  • Patients without phone number
  • Non French speaking patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282486


Contacts
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Contact: Teddy NOVAIS, MD 4 72 43 21 55 ext +33 teddy.novais@chu-lyon.fr
Contact: Valérie CHAMOUARD valerie.chamouard@chu-lyon.fr

Locations
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France
Hôpital des Charpennes, Institut du Vieillissement
Villeurbanne, France, 69100
Contact: Teddy NOVAIS, MD    4 72 43 21 55 ext +33    teddy.novais@chu-lyon.fr   
Contact: Valérie CHAMOUARD       valerie.chamouard@chu-lyon.fr   
Principal Investigator: Teddy NOVAIS, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04282486    
Other Study ID Numbers: 69HCL20_0086
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Willebrand disease
Additional relevant MeSH terms:
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Hemophilia A
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn