Medication Exposure in Older Patients With Constitutional Hemorrhagic Disease

Hemophilia Clinical Trial

— M-HEMORRH'AGE  

Official title:

Medication Exposure in Older Patients (AGEd > 65 Years) With Constitutional HEMORRHagic Disease (Haemophilia or Willebrand Disease).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282486
• Other study ID #: 69HCL20_0086
• Status: Completed
• Start date: July 22, 2020
• Est. completion date: January 29, 2021

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A
• Hemorrhagic Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital des Charpennes, Institut du Vieillissement	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At inclusion