At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill

This is a non-interventional, observational study to identify relevant concepts of SCIG treatment experience, as well as satisfaction regarding Alexa skill-assisted SCIG initiation, infusion, and disease/therapy management.

The study will enroll approximately 36 participants (26 patients/caregivers and 10 healthcare professionals [HCPs]). Participants will be enrolled into following observational Cohorts:

• Adult patients with primary immunodeficiency (PID)
• Caregivers of patients with a self-reported diagnosis of PID
• HCPs who prescribe SCIG for patients with PID

Interviews will be conducted by a trained qualitative research interviewer with patients, caregivers, and HCPs, and self-reported data will be collected.

This trial will be conducted in the United States. The overall duration of the study will be approximately 4 months.

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.