Collabree: A Remote Intervention to Improve the Regularity of Medication Intake

Study Overview
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Brief Summary
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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.

Official Title
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Collabree: A Targeted Behavioral Economics-based Remote Intervention to Improve Medication Adherence in Patients With Hypertension

Conditions
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Hypertension, Medication Adherence

Intervention / Treatment
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* Behavioral: Collabree Mobile Phone Application Medication Adherence Booster
* Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (simplified version)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group A<br>Patients receive the Collabree mobile phone application with a specific set of functions. | Behavioral: Collabree Mobile Phone Application Medication Adherence Booster<br>* Patients take part in a 90-day program to promote medication adherence and a 90-day follow-up through the Collabree application. Patients will receive more information as to the exact functions and use of the mobile phone application when the application is installed on their mobile phone.<br>|
| Experimental: Intervention Group B<br>Patients receive the Collabree mobile phone application with a specific set of functions. | Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (simplified version)<br>* Patients take part in a 90-day program to promote medication adherence and a 90-day follow-up through the Collabree application. Patients will receive more information as to the exact functions and use of the mobile phone application when the application is installed on their mobile phone.<br>|
| No Intervention: Control Group<br>Patients will not receive the Collabree application. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence (3 group comparison) | Mean change from baseline in medication adherence (monitored by pill count) at endpoint for the intervention Group A vs. intervention Group B relative to the control group. | 90 days | 
| Self-reported medication adherence | Mean change from baseline in in-app medication adherence (defined as the number of medications self-reported as taken during the intervention period of 90 days divided by the number of prescribed medications listed in the in-app medication plan in that same time period) at endpoint for the intervention Group A vs. intervention Group B relative to the control group. | 90 days | 
| Self-assessed medication adherence | Mean change from baseline in the score on the Hill-Bone Scale (German version) questionnaire on medication adherence for the intervention Group A vs. intervention Group B relative to the control group at endpoint. The Hill-Bone Compliance to Blood Pressure Therapy Scale (German) scores can range from 14 to 56. A higher score means worse compliance. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Health, Behavioral Change