Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06150534
Eligibility Criteria:
Inclusion Criteria:
Patients and caregivers:
* Adult patient (aged 18 years or older) with PID who recently initiated (within 4 months) or will soon initiate (within 30 days) HyQvia or Cuvitru at home or caregiver (aged 18 years or older) supporting participants (any age) with PID who recently initiated (within 4 months) or will soon initiate (within 30 days) HyQvia or Cuvitru at home.
* Patient has a self-reported physician diagnosis of PID.
* Resides in the US or US territories.
* Can speak and read English fluently.
* Able to participate in an interview(s).
* Must have a wireless network (Wi-Fi) at home (cannot be a wireless hotspot).
* Must have an existing Amazon account.
* Must be willing to receive an Amazon Echo Show device and connect the device to Wi-Fi.
* Must have a smartphone and be willing to download and use the Alexa application to access the Alexa Skill test.
Additional criteria for patients and caregivers completing qualitative debriefing interviews:
* Must have at least 2 SCIG infusions (HyQvia or Cuvitru) at a residential home or residential assisted living facility within 6 to12 weeks.
* Must attest to use of Alexa Skill to support at-home SCIG infusions.
For HCPs:
* Resides in the US or US territories.
* Must be an immunologist or registered nurse/nurse practitioner.
* Licensed to practice in the US.
* Can speak and read English fluently.
* Able to participate in a debriefing interview.
* Willing to provide informed consent.
* Must have a wireless network (Wi-Fi).
* Must have an existing Amazon account.
* Must be willing to receive an Amazon Echo Show device and connect the device to Wi-Fi.
* Must have a smartphone and be willing to download and use the Alexa application to access the Alexa Skill test.
* Must attest to exploration of Alexa Skill as a support tool for patients and caregivers administering SCIG infusions at home.
Exclusion Criteria
• Patients who were previously on SCIG and transitioned to either HyQvia or Cuvitru SCIG product will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06150534
Study Brief:
Protocol Section:
NCT06150534