Monitoring Medication Adherence in Patients Aged ≥65 Years on Polypharmacy: A Randomized Clinical Trial of the Itaca Mobile App vs. Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Medication Adherence Score Levels
研究概览
简要总结
The goal of this clinical trial is to learn if the use of a mobile app called Itaca improves medication adherence in older adults (aged ≥65) in a home care setting. It will also assess the impact of the app on patient engagement, patient activation, quality of life, and the app's usability in the intervention group. The main question it aims to answer is:
- Does the use of the Itaca mobile application improve medication adherence among older adults in the home care setting compared with usual care?
- Does the use of the Itaca mobile application improve patient engagement, patient activation, and quality of life among older adults in the home care setting compared with usual care?
Researchers will compare usual care to see if the intervention using the Itaca mobile app is more effective in improving medication adherence.
Participants will:
- In the intervention group, use the Itaca app for 3 months
- In the intervention group, receive monthly phone calls to support adherence to the study protocol, monitor app use, and address any barriers
- In the intervention group, complete the usability scale at the end of the 3-month intervention period
- In both the intervention and control groups, complete the questionnaires at enrollment and after 3 months, at the end of the intervention period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years with chronic condition
- •Taking three or more medications regardless of route of administration
- •Able to understand and speak Italian and to adhere to the study by signing written informed
- •Able to understand and speak Italian and to adhere to the study by signing written informed
排除标准
- •Pediatric or adult (< 65 years)
- •Taking fewer than three medications
- •With diagnosed cognitive impairment or psychiatric disorder that could interfere with participation in the study
研究组 & 干预措施
Intervention group: Itaca app mobile
干预措施: mobile app (Other)
Control group: Usual Care
干预措施: Usual Care Group (Other)
结局指标
主要结局
Change in Medication Adherence Score Levels
时间窗: From enrollment to end of treatment at 3 months
Primary outcome is the change in adherence level measured by the Medication Adherence Report Scale (MARS 5I), subject to prior authorization and/or licensing for use.
次要结局
- Change in Patient Health Engagement Score Levels(From enrollment to 3 months)
- Change in Health-Related Quality of Life Score Levels(From enrollment to 3 months)
- App Usability Score Levels(At the end of the intervention period, with a duration of 3 months)
研究者
Marco Di Muzio
Scientific Director
University of Roma La Sapienza