Primary Immunodeficiency Diseases (PID)NCT06150534
At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
An observational study of Primary Immunodeficiency Diseases (PID), run by Takeda at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Show all 25Show fewer
- 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.
Who cannot join
- Patients who were previously on SCIG and transitioned to either HyQvia or Cuvitru SCIG product will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Triangle Park
Raleigh, North Carolina, 27709
About this study
Official title: Evaluating the Treatment Experience During Initiation of Subcutaneous Immunoglobulin Replacement (SCIG) Therapy at Home Using Alexa Skill
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.
Read the 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.
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention | |
| 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. Receives: Other: No Intervention | |
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start27 Dec 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150534
- Sponsor's protocol ID
- PID-5005
- Status last verified
- Jun 2025
- First submitted
- 21 Nov 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Treatment Experience During Initiation of Subcutaneous Immunoglobulin Replacement (SCIG) Therapy at Home Using Alexa Skill
- ClinicalTrials.gov ID
- NCT06150534
- Acronym / sponsor ID
- PID-5005
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult Patients with PID | – | Other: No InterventionAdult 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 | – | Other: No InterventionCaregivers 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) | – | Other: No InterventionHCPs, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (25 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients who were previously on SCIG and transitioned to either HyQvia or Cuvitru SCIG product will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Adult Patients with PID, Caregivers of Patients with a Self-reported Diagnosis of PID, Healthcare Professionals (HCPs) |
Primary outcome
Identify Participant Experience, Including Convenience and Satisfaction, With Alexa Skill
Time frame: 4 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- To obtain more information on the study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Diseases (PID), run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Participant Experience, Including Convenience and Satisfaction, With Alexa Skill (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.