COMPLETED

At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill

Conditions

Primary Immunodeficiency Diseases (PID)Drug Therapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-27

Study Completion:2025-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06150534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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. * 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.
* 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Study Director

STUDY_DIRECTOR

Takeda

Study Locations (Sites)

Research Triangle Park

Raleigh, North Carolina, 27709

United States

Collaborators and Investigators

Sponsor: Takeda

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-27

Study Completion Date2025-02-28

Study Record Updates

Study Start Date2023-12-27

Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

Drug Therapy

Additional Relevant MeSH Terms

Primary Immunodeficiency Diseases (PID)