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

NCT ID: NCT05131074

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2024-11-30

Brief Summary

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.

Conditions

Hypertension; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group A

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

Group Type: EXPERIMENTAL

Collabree Mobile Phone Application Medication Adherence Booster

Intervention Type: BEHAVIORAL

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.

Intervention Group B

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

Group Type: EXPERIMENTAL

Collabree Mobile Phone Application Medication Adherence Booster (simplified version)

Intervention Type: BEHAVIORAL

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.

Control Group

Patients will not receive the Collabree application.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Collabree Mobile Phone Application Medication Adherence Booster

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.

Intervention Type: BEHAVIORAL

Collabree Mobile Phone Application Medication Adherence Booster (simplified version)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MediService AG

UNKNOWN

Sponsor Role: collaborator

Anjali Raja Beharelle

INDUSTRY

Sponsor Role: lead

Responsible Party

Anjali Raja Beharelle

Study Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anjali Raja Beharelle, PhD

Role: PRINCIPAL_INVESTIGATOR

Collabree AG

Locations

Collabree AG

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

COLLABREE-RS

Identifier Type: -

Identifier Source: org_study_id