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

NCT05131074 | Completed

• 1 other identifier: COLLABREE-RS
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Keywords

Digital Health; Behavioral Change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Medication adherence (3 group comparison)

  90 days

• Self-reported medication adherence

  90 days

• Self-assessed medication adherence

  90 days

Study Arms (3)

Intervention Group A

EXPERIMENTAL

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

Behavioral: Collabree Mobile Phone Application Medication Adherence Booster

Intervention Group B

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

Patients will not receive the Collabree application.

Interventions

Collabree Mobile Phone Application Medication Adherence Booster 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 A

Collabree Mobile Phone Application Medication Adherence Booster (simplified version) 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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anjali Raja Beharelle: lead
• MediService AG: collaborator

Study Sites (1)

Collabree AG

Zurich, Canton of Zurich, 8002, Switzerland

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anjali Raja Beharelle, PhD

  Collabree AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Sponsor-Investigator

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: March 10, 2022
• Primary Completion: August 23, 2024
• Study Completion: November 24, 2024
• Last Updated: March 18, 2026

Record last verified: 2024-02

Locations

CH (1)