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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Digital Health program with participants using an autoinjector delivered via the Sidekick mobile application (app)
Húðlæknastöðin dermatology clinic
Kopavogur, Iceland
Retention/Engagement - completion
Percentage of users that complete the program. Completion is defined as finishing 75% of the program (9/12 weeks).
Time frame: 12 weeks
Retention/Engagement - activity
Percentage of active users throughout the program. Active is defined as visiting the app at least once per week.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 12 weeks
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Enrollment
27
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.
Time frame: 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.
Time frame: 12 weeks