NCT04282486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 22, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

February 21, 2020

Last Update Submit

July 12, 2021

Conditions

Keywords

Willebrand disease

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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%)

You may not qualify if:

  • Patients without phone number
  • Non French speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Charpennes, Institut du Vieillissement

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 24, 2020

Study Start

July 22, 2020

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations