Digital Health Program With Participants Using an Autoinjector

NCT06112184 | Completed

• 1 other identifier: SK-M11/3A1-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune-Mediated Inflammatory Disease

Keywords

self-injection; digital solution; lifestyle change; disease education; medication adherence; immune-mediated inflammatory disease; IMID; healthy lifestyle

Outcome Measures

Primary Outcomes (3)

• Retention/Engagement - completion

  Percentage of users that complete the program. Completion is defined as finishing 75% of the program (9/12 weeks).

  12 weeks

• Retention/Engagement - activity

  Percentage of active users throughout the program. Active is defined as visiting the app at least once per week.

  12 weeks

• Usability of the app

  Average score of the Mobile Health App Usability Questionnaire (MAUQ) at end of program. The MAUQ is a self-administered questionnaire that has three subscales and is composed of in total 21 questions with a Likert scale of 7 options where 1 represents "strongly agree" to 7 "strongly disagree". Scores on the MAUQ range from 21 to 147, with a higher score representing better usability.

  12 weeks

Secondary Outcomes (4)

• Assessment of self-injection experience

  12 weeks

• Use of in-app reminders

  12 weeks

• Compliance with medication regime

  12 weeks

• Evaluate the impact of patient education

  12 weeks

Study Arms (1)

All participants

EXPERIMENTAL

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

Other: SK-M11/3A1 Digital health program

Interventions

SK-M11/3A1 Digital health program OTHER

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

Also known as: SK-M11/3A1 Master your treatment

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidekick Health: lead

Study Sites (1)

Húðlæknastöðin dermatology clinic

Kopavogur, 201, Iceland

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bárður L Sigurgeirsson, MD, PhD

  Húðlæknastöðin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, single-arm, feasibility study

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: December 10, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)