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

Anjali Raja Beharelle

Status: Invitation-only

Conditions: Hypertension; Medication Adherence

Treatments: Behavioral: Collabree Mobile Phone Application Medication Adherence Booster; Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (simplified version)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05131074

COLLABREE-RS

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent as documented by signature.
2. Over 50 years of age on date of randomization.
3. Patient received prescription medicine against hypertension by post from MediService.
4. 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.
5. Participant administers their own medications.
6. Participant owns a smartphone with a data plan or constant internet access during the study reporting events and at home to use the application.
7. Minimal required smartphone operating system is iOS 12 and Android 8 (Oreo).
8. Adequate communication in German or Swiss-German (all study documentation will only be set to the German language).

Exclusion criteria

1. Inability to operate a mobile phone and the Collabree application.
2. Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
3. Enrollment of the Sponsor-Investigator, their family members, employees, and other dependent persons.
4. Participation in another interventional clinical trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Intervention Group A

Experimental group

Description:

Patients receive the Collabree mobile phone application with a specific set of functions.

Treatment:

Behavioral: Collabree Mobile Phone Application Medication Adherence Booster

Intervention Group B

Experimental group

Description:

Patients receive the Collabree mobile phone application with a specific set of functions.

Treatment:

Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (simplified version)

Control Group

No Intervention group

Description:

Patients will not receive the Collabree application.