Digital Health Program With Participants Using an Autoinjector

Sidekick Health

Status

Completed

Conditions

Immune-Mediated Inflammatory Disease

Treatments

Other: SK-M11/3A1 Digital health program

Study type

Interventional

Funder types

Industry

Identifiers

NCT06112184

SK-M11/3A1-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.