Status:
COMPLETED
At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
Lead Sponsor:
Takeda
Conditions:
Primary Immunodeficiency Diseases (PID)
Eligibility:
All Genders
18+ years
Brief Summary
The main aim of this study is to determine the impact of digital health technology, such as Alexa Skill, used to support the initiation of home-based subcutaneous immunoglobulin (SCIG) treatment, trea...
Detailed Description
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 dise...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06150534
Start Date
December 27 2023
End Date
February 28 2025
Last Update
June 13 2025
Active Locations (1)
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1
Research Triangle Park
Raleigh, North Carolina, United States, 27709