NCT06150534

At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2023-12-27
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2023-11-29
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States