Collabree: A Targeted Behavioral Economics-based Remote Intervention to Improve Medication Adherence in Patients With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Medication Adherence
研究概览
简要总结
This is a clinical study to improve the regularity of medication intake for high blood pressure. Adult women and men who are over 50 years old, who have received a prescription drug for high blood pressure from MediService, and who have to take at least 4 tablets per day (of which at least 1 dose of medication per day is for high blood pressure) can participate in this study.
The investigators intend to examine whether Collabree, a mobile phone application, is effective in supporting patients with hypertension to more successfully following their therapy plan in order to improve the regularity of medication intake.
The study includes a 90-day intervention phase and a 90-day follow-up. The study does not require any therapy adjustments and no visits to a study center are necessary. The participants conduct the study independently at home. Participants will also fill out questionnaires.
Participants are randomly assigned to one of 3 groups in a ratio of 1: 1: 1. Two of these groups will receive the Collabree mobile phone application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent as documented by signature.
- •Over 50 years of age on date of randomization.
- •Patient received prescription medicine against hypertension by post from MediService.
- •Prescribed a therapy against hypertension consisting of 4 or more tablets taken per day. At least 1 dose of medication per day must be against hypertension.
- •Participant administers their own medications.
- •Participant owns a smartphone with a data plan or constant internet access during the study reporting events and at home to use the application.
- •Minimal required smartphone operating system is iOS 12 and Android 8 (Oreo).
- •Adequate communication in German or Swiss-German (all study documentation will only be set to the German language).
排除标准
- •Inability to operate a mobile phone and the Collabree application.
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
- •Enrollment of the Sponsor-Investigator, their family members, employees, and other dependent persons.
- •Participation in another interventional clinical trial.
研究组 & 干预措施
Intervention Group A
Patients receive the Collabree mobile phone application with a specific set of functions.
干预措施: Collabree Mobile Phone Application Medication Adherence Booster (Behavioral)
Intervention Group B
Patients receive the Collabree mobile phone application with a specific set of functions.
干预措施: Collabree Mobile Phone Application Medication Adherence Booster (simplified version) (Behavioral)
Control Group
Patients will not receive the Collabree application.
结局指标
主要结局
Medication Adherence
时间窗: 90 days
Difference between intervention Group A and the control group in mean medication adherence at endpoint (i.e. the endpoint visit at 90 days) as measured by pill count.
次要结局
- Self-reported medication adherence(90 days)
- Medication adherence (3 group comparison)(90 days)
- Self-assessed medication adherence(90 days)
研究者
Anjali Raja Beharelle
Study Sponsor-Investigator
Collabree AG