A Prospective, Single-arm, Feasibility Study to Evaluate the Performance of the SK-M11/3A1 Digital Health Program With Participants Using an Autoinjector
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Retention/Engagement - activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
All participants
All participants will use the SK-M11/3A1 digital health program for 12 weeks.
干预措施: SK-M11/3A1 Digital health program (Other)
结局指标
主要结局
Retention/Engagement - activity
时间窗: 12 weeks
Percentage of active users throughout the program. Active is defined as visiting the app at least once per week.
Retention/Engagement - completion
时间窗: 12 weeks
Percentage of users that complete the program. Completion is defined as finishing 75% of the program (9/12 weeks).
Usability of the app
时间窗: 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.
次要结局
- Assessment of self-injection experience(12 weeks)
- Use of in-app reminders(12 weeks)
- Evaluate the impact of patient education(12 weeks)
- Compliance with medication regime(12 weeks)