Clinical trial NCT06112184: Digital Health Program With Participants Using an Autoinjector
Official title: A Prospective, Single-arm, Feasibility Study to Evaluate the Performance of the SK-M11/3A1 Digital Health Program With Participants Using an Autoinjector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune-Mediated Inflammatory Disease
Keywords: self-injection
digital solution
lifestyle change
disease education
medication adherence
immune-mediated inflammatory disease
IMID
healthy lifestyle
Lead sponsor: Sidekick Health
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single-arm, feasibility study
Primary purpose: SUPPORTIVE_CARE

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 delivered via the Sidekick mobile application (app).

The study objective is to evaluate the performance and safety of the SK-M11/3A1 digital health program when added to routine medical treatment of patients with Immune-Mediated Inflammatory Disease (IMID). All participants are using a prescribed medication for regular subcutaneous injection provided in a prefilled autoinjector.

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 in the treatment burden, the act of self-injecting and at-home administration inevitably imposes a substantial responsibility and burden on the patient.

To support the efforts to improve medication adherence and make the process of self-injecting more user friendly and easy, Sidekick Health (SKH) has developed a digital health program designed specifically for this purpose (SK-M11). SKH has paired this with disease-specific content that is indicated for patients with an Immune-Mediated Inflammatory Disease (IMID) (SK-3A1), addressing some of the most common challenges these patients encounter, as well as general assistance with making healthy lifestyle choices.

The aim of this study is primarily to assess the acceptability and feasibility of combining the SK-M11 and SK-3A1 and adding the digital health program to the Standard of Care (SoC) by measuring participants engagement, retention and satisfaction. Up to 30 IMID patients using a prescribed medication for regular subcutaneous injection provided in a prefilled autoinjector for self-injection in the home environment will be included. The participants will use SK-M11/3A1 for the study period of 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Retention/Engagement - completion
timeFrame: 12 weeks
measure: Retention/Engagement - activity
timeFrame: 12 weeks
measure: Usability of the app
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of self-injection experience
timeFrame: 12 weeks
measure: Use of in-app reminders
timeFrame: 12 weeks
measure: Compliance with medication regime
timeFrame: 12 weeks
measure: Evaluate the impact of patient education
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kópavogur
country: Iceland
facility: Húðlæknastöðin dermatology clinic
Study officials:
affiliation: Húðlæknastöðin
name: Bárður L Sigurgeirsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: