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

February 8, 2024 updated by: Anjali Raja Beharelle

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group A
Patients receive the Collabree mobile phone application with a specific set of functions.
Behavioral: 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.
Experimental: Intervention Group B
Patients receive the Collabree mobile phone application with a specific set of functions.
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.
No Intervention: Control Group
Patients will not receive the Collabree application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence
Time Frame: 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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported medication adherence
Time Frame: 90 days
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
Medication adherence (3 group comparison)
Time Frame: 90 days
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-assessed medication adherence
Time Frame: 90 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anjali Raja Beharelle

Collaborators

MediService AG

Investigators

  • Principal Investigator: Anjali Raja Beharelle, PhD, Collabree AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLLABREE-RS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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