Clinical trial NCT06150534: At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
Official title: Evaluating the Treatment Experience During Initiation of Subcutaneous Immunoglobulin Replacement (SCIG) Therapy at Home Using Alexa Skill
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immunodeficiency Diseases (PID)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-11-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility 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.

Primary outcomes:
measure: Identify Participant Experience, Including Convenience and Satisfaction, With Alexa Skill
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Research Triangle Park
state: North Carolina
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: