Digital Health Program With Participants Using an Autoinjector

NCT ID: NCT06112184

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-10
• Study Completion Date: 2024-10-01

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.

Conditions

Immune-Mediated Inflammatory Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

All participants

All participants will use the SK-M11/3A1 digital health program for 12 weeks.

Group Type: EXPERIMENTAL

SK-M11/3A1 Digital health program

Intervention Type: OTHER

Digital Health program with participants using an autoinjector delivered via the Sidekick mobile application (app)

Interventions

SK-M11/3A1 Digital health program

Digital Health program with participants using an autoinjector delivered via the Sidekick mobile application (app)

Intervention Type: OTHER

Other Intervention Names

SK-M11/3A1 Master your treatment

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidekick Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bárður L Sigurgeirsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Húðlæknastöðin

Locations

Húðlæknastöðin dermatology clinic

Kopavogur, , Iceland

Countries

Iceland

Other Identifiers

SK-M11/3A1-001

Identifier Type: -

Identifier Source: org_study_id