At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill

Takeda

Status: Completed

Conditions: Primary Immunodeficiency Diseases (PID)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06150534

PID-5005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

22 participants in 3 patient groups

Adult Patients with PID

Description:

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.

Treatment:

Other: No Intervention

Caregivers of Patients with a Self-reported Diagnosis of PID

Description:

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.

Treatment:

Other: No Intervention

Healthcare Professionals (HCPs)

Description:

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.

Treatment:

Other: No Intervention