Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT06150534
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2023-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Evaluating the Treatment Experience During Initiation of Subcutaneous Immunoglobulin Replacement (SCIG) Therapy at Home Using Alexa Skill
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: