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
1 other identifier
observational
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2023
CompletedFirst Posted
Study publicly available on registry
November 29, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedJune 13, 2025
June 1, 2025
1.2 years
November 21, 2023
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identify Participant Experience, Including Convenience and Satisfaction, With Alexa Skill
Qualitative interviews with patients, caregivers, and HCPs who will be using the Alexa Skill to support initiation of SCIG for PID to characterize their experience, including convenience and satisfaction. Qualitative interviews will be semi-structured to comprehensively assess confidence and satisfaction, but also open-ended to give patients, families, and HCPs freedom to discuss their experience.
4 months
Study Arms (3)
Adult Patients with PID
Adult patients with PID who recently started or will soon begin to complete SCIG (HyQvia or Cuvitru) infusions independently will be interviewed before and/or after the use of Alexa Skill.
Caregivers of Patients with a Self-reported Diagnosis of PID
Caregivers who recently started or will soon begin infusing SCIG (HyQvia or Cuvitru) for patients with a self-reported diagnosis of PID will be interviewed before and/or after the use of Alexa Skill.
Healthcare Professionals (HCPs)
HCPs, specifically, clinical immunologists who prescribe SCIG for the treatment of PID and nurses who have experience administering SCIG will be interviewed after the use of Alexa Skill.
Interventions
This is a non-interventional study.
Eligibility Criteria
The study population will include adult patients and/or caregivers supporting patients with PID and HCPs involved in treating patients with PID who reside in the United States (US).
You may qualify if:
- 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.
- +10 more criteria
You may not qualify if:
- Patients who were previously on SCIG and transitioned to either HyQvia or Cuvitru SCIG product will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Research Triangle Park
Raleigh, North Carolina, 27709, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2023
First Posted
November 29, 2023
Study Start
December 27, 2023
Primary Completion
February 28, 2025
Study Completion
February 28, 2025
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.