Status:
COMPLETED
Digital Health Program With Participants Using an Autoinjector
Lead Sponsor:
Sidekick Health
Conditions:
Immune-Mediated Inflammatory Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, single-arm, feasibility study. Up to thirty (30) participants meeting study eligibility criteria will use the SK-M11/3A1 digital health program for 12 weeks. The program will be...
Detailed Description
Numerous therapies are formulated for subcutaneous injections, enabling patients and caregivers to administer them at home instead of intravenously in-clinic. Despite the notable benefit and decrease ...
Eligibility Criteria
Inclusion
- Adults 18 years or older
- Patients diagnosed with IMID and already using or initiating an IMID therapy with a medicine for regular subcutaneous injection provided in a prefilled autoinjector for self-injection in the home environment, as prescribed by their doctor.
- Owns a smartphone compatible with the SK-M11/3A1 digital health program and is willing and able to use it
- Participant has been informed of the nature of the study and has been provided with electronic informed consent approved by the appropriate Independent Ethics Committee (IEC)
- Willing and able to comply with all protocol-specified items (app use, all scheduled visits, and completing questionnaires/surveys)
Exclusion
- The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives
- Pregnant and/or breastfeeding females (self-reported) at baseline or during the course of the study (12 weeks)
- Enrollment in a concurrent study in which the study treatment may confound the evaluation of the investigational program.
Key Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06112184
Start Date
December 10 2023
End Date
October 1 2024
Last Update
May 25 2025
Active Locations (1)
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1
Húðlæknastöðin dermatology clinic
Kopavogur, Iceland, 201