Digital Health Program With Participants Using an Autoinjector

A Prospective, Single-arm, Feasibility Study to Evaluate the Performance of the SK-M11/3A1 Digital Health Program With Participants Using an Autoinjector

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.

Study Overview

• Status: Recruiting
• Conditions: Immune-Mediated Inflammatory Disease
• Intervention / Treatment: Other: SK-M11/3A1 Digital health program

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kolbrún Sveinsdóttir, MSc Pharm; Phone Number: +3547792943; Email: kolbrun@sidekickehealth.com

Study Locations

• Iceland
  • Kópavogur, Iceland, 201
    • Recruiting
    • Húðlæknastöðin dermatology clinic
    • Contact: Sigríður Ólafsdóttir; Phone Number: +354520440; Email: sigridur@hls.is

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; All participants will use the SK-M11/3A1 digital health program for 12 weeks.	Other: SK-M11/3A1 Digital health program; Digital Health program with participants using an autoinjector delivered via the Sidekick mobile application (app); Other Names: SK-M11/3A1 Master your treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of in-app reminders	Percentage of users actively using in-app reminders (% users reacting to reminders) and medication log (% users entering data relating to the medicine and dosing)	12 weeks
Assessment of self-injection experience	Changes in self-reported scores (from Baseline to Week 12) as measured by the Self-Injection Assessment Questionnaire (SIAQ). The SIAQ is a self-reported questionnaire that is divided into pre- and post-study modules and for the purpose of this study, only the pre-study module is used. It is composed of 7 questions with a Likert scale of 5 options. For questions 1 to 6 a score of 1 represents "not at all" to 5 "extremely". For question 7 a score of 1 represents "very dissatisfied" to 5 "very satisfied". Scores on the SIAQ range from 7 to 35, with a lower score representing a good self-injection experience.	12 weeks
Compliance with medication regime	Changes in self-reported scores (from Baseline to Week 12) as measured by the 5-item Compliance Questionnaire for Rheumatology (CQR5). The CQR5 is composed of 5 questions with a Likert scale of 5 options where 1 represents "completely disagree" to 5 "completely agree". Scores on the CQR5 range from 5 to 25, with a lower score representing lower compliance.	12 weeks
Evaluate the impact of patient education	Change in self-reported score (from baseline to 12 weeks) as measured by the Health Education Impact Questionnaire (heiQ) score. The heiQ has 8 subscales and is composed of in total 42 questions with a Likert scale of 4 options where 1 represents "strongly disagree" to 4 "strongly agree". Scores on the heiQ range from 42 to 168, with a lower score representing a low impact on patient education.	12 weeks

Collaborators and Investigators

• Sponsor: Sidekick Health
• Investigators: Principal Investigator: Bárður L Sigurgeirsson, MD, PhD, Húðlæknastöðin

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: healthy lifestyle; lifestyle change; medication adherence; self-injection; digital solution; IMID; disease education; immune-mediated inflammatory disease
• Other Study ID Numbers: SK-M11/3A1-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized Individual Participant Data may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No