Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06150534
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.
Study:
NCT06150534
Study Brief:
Protocol Section:
NCT06150534