Needs Assessment of Knowledge, Beliefs, and Attitudes of Patients With Hemophilia B About Gene Therapy
NCT ID: NCT05044845
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2022-01-18
2025-10-14
Brief Summary
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Primary Objective:
To assess baseline knowledge, beliefs, and attitudes about gene therapy held by hemophilia B patients globally
Secondary Objectives:
1. To explore healthcare workers' (i.e., physicians, nurses, social workers, educators/academic coordinators) perspectives regarding the education needs of hemophilia B patients globally
2. To explore healthcare workers beliefs and attitudes about gene therapy
3. To identify preferences of patients with hemophilia B and their healthcare workers on how/by what method or pathway educational content should be provided.
Detailed Description
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Interviews will be performed by experienced qualitative interviewers in the official language of each participating site. Interviews will last approximately 45-60 minutes and will be performed only once. All interviews will be audio recorded and obtained information will be analyzed using semantic content analysis to identify common themes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hemophilia B patients
Patients ≥12 years of age with a diagnosis of moderate (FIX ≥1% and ≤2%) or severe (\<1%) hemophilia B
Interview
Semi structured interview will be conducted virtually using an online video-conferencing platform, phone or in person.
Parents or Caregivers
Parents or caregivers to patients with hemophilia 12-17 years of age
Interview
Semi structured interview will be conducted virtually using an online video-conferencing platform, phone or in person.
Healthcare Workers
Doctors, nurses, social workers, pharmacists and educators who participate in the care of hemophilia B patients
Interview
Semi structured interview will be conducted virtually using an online video-conferencing platform, phone or in person.
Interventions
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Interview
Semi structured interview will be conducted virtually using an online video-conferencing platform, phone or in person.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of moderate (FIX ≥1% and ≤2%) or severe (\<1%) hemophilia B
* Parents or caregivers to patients with hemophilia 12-17 years of age
\- Doctors, nurses, social workers, pharmacists and educators who participate in the care of hemophilia B patients
Exclusion Criteria
* Diagnosis of other non-Hemophilia B bleeding disorders
* Health care workers who do not participate in the care of hemophilia B patients
* Healthcare worker who is conducting the interviews
12 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Nidhi Bhatt, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Civil Service Hospital
Kathmandu, , Nepal
Hospital Dos De Mayo
Lima, , Peru
National Hospital of Sri Lanka
Colombo, , Sri Lanka
Ramathibodi Hospital
Bangkok, , Thailand
National Institute of Hematology and Blood Transfusion
Hanoi, , Vietnam
Countries
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Related Links
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St. Jude Children's Research Hospital
ClinicalTrials Open at St. Jude
Other Identifiers
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BINFORMED
Identifier Type: -
Identifier Source: org_study_id