Immune-Mediated Inflammatory DiseaseNCT06112184
Digital Health Program With Participants Using an Autoinjector
A study testing SK-M11/3A1 Digital health program in people with Immune-Mediated Inflammatory Disease, run by Sidekick Health at 1 site in Iceland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-Mediated Inflammatory Disease
- What is being tested?
- SK-M11/3A1 Digital health program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIceland
- Study dates
- 10 Dec 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Immune-Mediated Inflammatory Disease
- Being tested
- SK-M11/3A1 Digital health program
- Keywords
- self-injection, digital solution, lifestyle change, disease education, medication adherence, immune-mediated inflammatory disease, IMID, healthy lifestyle
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-M11/3A1 Digital health programOther
Also called SK-M11/3A1 Master your treatment
Digital Health program with participants using an autoinjector delivered via the Sidekick mobile application (app)
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will use the SK-M11/3A1 digital health program for 12 weeks. Receives: Other: SK-M11/3A1 Digital health program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention/Engagement - completion
Percentage of users that complete the program. Completion is defined as finishing 75% of the program (9/12 weeks).
Measured: 12 weeks
Retention/Engagement - activity
Percentage of active users throughout the program. Active is defined as visiting the app at least once per week.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start10 Dec 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-Mediated Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single-arm, feasibility study
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidekick Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bárður L Sigurgeirsson, MD, PhD, Principal investigator, Húðlæknastöðin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112184
- Sponsor's protocol ID
- SK-M11/3A1-001
- Status last verified
- May 2025
- First submitted
- 26 Oct 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Feasibility Study to Evaluate the Performance of the SK-M11/3A1 Digital Health Program With Participants Using an Autoinjector
- ClinicalTrials.gov ID
- NCT06112184
- Acronym / sponsor ID
- SK-M11/3A1-001
- Conditions
- Immune-Mediated Inflammatory Disease
- Keywords
- self-injection, digital solution, lifestyle change, disease education, medication adherence, immune-mediated inflammatory disease, IMID, healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sidekick HealthIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-arm, feasibility study
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: SK-M11/3A1 Digital health programAll participants will use the SK-M11/3A1 digital health program for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SK-M11/3A1 Digital health programAlso: SK-M11/3A1 Master your treatmentDigital Health program with participants using an autoinjector delivered via the Sidekick mobile application (app) | Other | All participants |
Primary outcome
Retention/Engagement - completion
Time frame: 12 weeks
Percentage of users that complete the program. Completion is defined as finishing 75% of the program (9/12 weeks).
Retention/Engagement - activity
Time frame: 12 weeks
Percentage of active users throughout the program. Active is defined as visiting the app at least once per week.
Usability of the app
Time frame: 12 weeks
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.
4 secondary outcomes
Assessment of self-injection experience
Time frame: 12 weeks
Use of in-app reminders
Time frame: 12 weeks
Compliance with medication regime
Time frame: 12 weeks
Evaluate the impact of patient education
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bárður L Sigurgeirsson, MD, PhD principal investigator
Húðlæknastöðin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SK-M11/3A1 Digital health program in people with Immune-Mediated Inflammatory Disease, run by Sidekick Health at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention/Engagement - completion (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.