Digital Health Program With Participants Using an Autoinjector

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Immune-Mediated Inflammatory Disease

Intervention / Treatment
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* Other: SK-M11/3A1 Digital health program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, single-arm, feasibility study
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-injection, digital solution, lifestyle change, immune-mediated inflammatory disease, healthy lifestyle, disease education, medication adherence, IMID