NCT02542228

Construction of a Health-related Quality of Life (HR-QOL) Questionnaire for Patients With Primary Antibody Deficiency Disease

Construction and Validation of a Health-related Quality of Life (HR-QOL) Instrument for Patients With Primary Antibody Deficiency Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 person's 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 Children's/ Harvard, Midwest Immunology, Johns Hopkins, Children's Hospital at Baylor University, and the University of South Florida at All Children's 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.

Conditions

• Immune Deficiency, Antibody

Interventions

Type	Name	Description
OTHER	questionnaire survey	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. A case report form (CRF) of their clinical condition and demographics will be collected at the time of informed consent.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-01-01
• Completion: 2016-09-01
• First posted: 2015-09-04
• Last updated: 2017-01-13