Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT03549858

Conditions

Hemophilia

Chronic Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Quality of life measure (survey)

Study Details

Brief summary:

The PROBE Phase-3 study will collect data on patient reported outcomes, burdens, and experiences in patients living with hemophilia. The investigators will perform comparisons among countries, within country over time, within country against national normative data.

Conditions

Hemophilia

Chronic Disease

Study ID

NCT03549858

Start date

Jan 1, 2018

Status verified date

Aug, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • PWH will be recruited through national hemophilia patient organizations utilizing their existing membership rosters, social media outlets and meetings / events. The investigators are not proposing a pre-determined method of PWH recruitment. They will utilize the information acquired in the workshop and take-home project to inform best practice in recruitment methodology for the study. The investigators may consider requesting different countries test different PWH recruitment strategies to test reproducibility.

In the future, the questionnaire might also be administered to patients with other chronic conditions.

Exclusion Criteria:

  • Disease severity and Age bands or age limits (e.g. ≥ Age 18) may be utilized to narrow the study population.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Quality of life measure (survey)

The QoL tool is a questionnaire

Primary outcome measure

  • Between-countries variability of the PROBE score [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Mark Skinner

202.253.8342mskinnerdc@gmail.com

Alfonso Iorio

iorioa@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S4B2

Contacts

Alfonso Iorio, MD

9055259140iorioa@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-08-22.