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NCT06150534 Clinical Trial

At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill

Primary Immunodeficiency Diseases (PID) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06150534
Other study ID # PID-5005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 27, 2023
Est. completion date August 18, 2024

Study information
Verified date May 2024
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date August 18, 2024
Est. primary completion date August 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations
Country Name City State
United States Research Triangle Park Raleigh North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT02593188 - Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
Completed NCT03116347 - Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects Phase 4
Completed NCT00157079 - Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders Phase 3
Completed NCT01412385 - Immune Globulin Subcutaenous (Human), 20% Phase 2/Phase 3
Completed NCT00161993 - Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia) Phase 2
Completed NCT01175213 - Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID Phase 3
Completed NCT01218438 - Phase 2/3 Study of IGSC, 20% in PIDD Phase 2/Phase 3
Completed NCT05150340 - A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) Phase 3
Not yet recruiting NCT06076642 - A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases Phase 3
Completed NCT00782106 - Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously Phase 1/Phase 2
Completed NCT01485796 - Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD Phase 2/Phase 3
Completed NCT00814320 - Gammagard Liquid and rHuPH20 in PID Phase 3
Completed NCT04346108 - A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) Phase 3

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