Evaluating the Treatment Experience During Initiation of Subcutaneous Immunoglobulin Replacement (SCIG) Therapy at Home Using Alexa Skill
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Sponsor
- Takeda
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Identify Participant Experience, Including Convenience and Satisfaction, With Alexa Skill
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.