At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
United States22 participantsStarted 2023-12-27
Plain-language 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, treatment management, and overall participant experience.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identify Participant Experience, Including Convenience and Satisfaction, With Alexa Skill