Ignite Creation Date:
2024-05-06 @ 7:30 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02542228
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2015-08-31
Brief Title:
Construction of a Health-related Quality of Life HR-QOL Questionnaire for Patients With Primary Antibody Deficiency Disease
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Construction and Validation of a Health-related Quality of Life HR-QOL Instrument for Patients With Primary Antibody Deficiency Disease
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HR-QOLPIDD
Brief Summary:
This research is being done to construct a survey questionnaire a quality of life tool to determine the health well-being ability to perform daily activities and physical social and emotional functioning in participants with primary immunodeficiency disorders PIDD This quality of life QOL tool will help physicians understand the effects of PIDD on a persons health These quality of life surveys are important tools for physicians to measure outcomes for satisfaction and effects of treatment
Detailed Description:
A preliminary patient and clinician-generated scale will be validated and modified during a multicenter scale validity study involving 85 patients from 5 sites Feasibility surveys have been conducted and available sites that can be included in this study include Boston Childrens Harvard Midwest Immunology Johns Hopkins Childrens Hospital at Baylor University and the University of South Florida at All Childrens Hospital Johns Hopkins Medicine Patients will be enrolled at a clinic non-infusion visit The purpose of the study will be explained and informed consent obtained A case report form CRF of their clinical condition and demographics will be completed based on the information obtained by the local study coordinator during the interview at the time of the visit The HR-QOL PIDD survey will be administered to the patient by the site PI or the study coordinator A second survey will be handed to the patient to take home with them and completed at 48-120 hrs after the clinic visit The study coordinator will contact the patient during this period to ensure that the patient completes this second survey and returns it to the local study site If a patient is on SCIg they will be asked to take the survey 3 days after the SC infusion if weekly and complete the paired survey 48-72 hrs later before another SCIg infusion is scheduled The study coordinator will obtain an interim history for the period between the paired surveys to ensure that in general the condition of the patient has not changed that could invalidate the validation process and this information will be documented on the addendum case report form CRF Patient can return the surveys to the site study coordinator either by mail fax or electronically by scanning the documents Paired surveys will be returned to the central study site USF St Petersburg for data input
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None