Health TrialsbyHealthPanel

Patient Reported Outcomes Burdens and Experiences - Phase 3

ConditionsHemophiliaChronic Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Moderate / Severe PWH (Age bands or limits may be utilized to narrow the study population). Patients will be recruited according to the final inclusion criteria. No randomization will be required. Two moderate to large test runs of the inventory will be conducted in each country three months apart to demonstrate reproducibility. PWH participating in each of the two test runs may, but would not necessarily be the same.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quality of life measure (survey)

    Other intervention

    The QoL tool is a questionnaire

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Between-countries variability of the PROBE score

Mean difference and standard deviation of the PROBE score between countries.

Time frame
2 years

Secondary outcomes

1

Within-countries variability of the PROBE score

Mean difference and standard deviation of the PROBE score in repeated assessments within countries.

Time frame
2 years
2

Within-countries comparison of the PROBE score in PWH against national normative data

Mean difference and standard deviation of the PROBE score in PWH against national normative data within countries.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Patient Outcomes Research Group (PORG)

Collaborator

National Hemophilia Foundation

Collaborator

Source ClinicalTrials.gov
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