Using Alexa to help with at-home immunoglobulin therapy for primary immunodeficiency

Evaluating the Treatment Experience During Initiation of Subcutaneous Immunoglobulin Replacement (SCIG) Therapy at Home Using Alexa Skill

This study is testing whether using an Alexa device can make it easier and more satisfying for people with primary immunodeficiency to manage their at-home immunoglobulin therapy.

Quick facts

• Study type: Observational
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 1 site (Raleigh, North Carolina)
• Trial ID: NCT06150534 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the impact of an Alexa Skill on the experience of patients with primary immunodeficiency diseases (PID) who are initiating home-based subcutaneous immunoglobulin (SCIG) therapy. It will involve approximately 36 participants, including adult patients, caregivers, and healthcare professionals, who will provide qualitative feedback through interviews. The study focuses on understanding treatment management and satisfaction with the digital health technology used in SCIG therapy. Data will be collected over a period of four months in the United States.

Who should consider this trial

Good fit: Ideal candidates include adult patients with a recent or upcoming initiation of home-based SCIG therapy and their caregivers.

Not a fit: Patients who do not have a self-reported diagnosis of primary immunodeficiency or those who are not initiating SCIG therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management and experience of at-home immunoglobulin therapy for patients with primary immunodeficiency.

How similar studies have performed: While the use of digital health technology in treatment management is gaining traction, this specific approach using Alexa for SCIG therapy is relatively novel and has not been extensively tested.

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.

Where this trial is running

Raleigh, North Carolina

• Research Triangle Park — Raleigh, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Primary Immunodeficiency Diseases; Drug Therapy