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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04282486
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 22.6

Study Details

Study Description

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	Phase
Hemophilia	Other: Telephone interview

Study Design

• Study Type: Observational
• Actual Enrollment: 142 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).
• Actual Study Start Date: Jul 22, 2020
• Actual Primary Completion Date: Jan 29, 2021
• Actual Study Completion Date: Jan 29, 2021

Outcome Measures

Primary Outcome Measures

1. Potentially inappropriate medication (PIM) prevalence using EU-(7) PIM list. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital des Charpennes, Institut du Vieillissement	Villeurbanne		France	69100

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04282486
• Other Study ID Numbers: 69HCL20_0086
• First Posted: Feb 24, 2020
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• 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: Hemophilia A; Hemorrhagic Disorders

Study Results

No Results Posted as of Jul 13, 2021