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

Primary Purpose

Hypertension, Medication Adherence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Collabree Mobile Phone Application Medication Adherence Booster
Collabree Mobile Phone Application Medication Adherence Booster (simplified version)
Sponsored by
Anjali Raja Beharelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Digital Health, Behavioral Change

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Collabree AG

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention Group A

Intervention Group B

Control Group

Arm Description

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

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

Patients will not receive the Collabree application.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 11, 2021
Last Updated
February 7, 2023
Sponsor
Anjali Raja Beharelle
Collaborators
MediService AG
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1. Study Identification

Unique Protocol Identification Number
NCT05131074
Brief Title
Collabree: A Remote Intervention to Improve the Regularity of Medication Intake
Official Title
Collabree: A Targeted Behavioral Economics-based Remote Intervention to Improve Medication Adherence in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anjali Raja Beharelle
Collaborators
MediService AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Medication Adherence
Keywords
Digital Health, Behavioral Change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group A
Arm Type
Experimental
Arm Description
Patients receive the Collabree mobile phone application with a specific set of functions.
Arm Title
Intervention Group B
Arm Type
Experimental
Arm Description
Patients receive the Collabree mobile phone application with a specific set of functions.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will not receive the Collabree application.
Intervention Type
Behavioral
Intervention Name(s)
Collabree Mobile Phone Application Medication Adherence Booster
Intervention Description
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
Intervention Name(s)
Collabree Mobile Phone Application Medication Adherence Booster (simplified version)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Medication adherence (3 group comparison)
Description
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.
Time Frame
90 days
Title
Self-reported medication adherence
Description
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.
Time Frame
90 days
Title
Self-assessed medication adherence
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjali Raja Beharelle, PhD
Organizational Affiliation
Collabree AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Collabree AG
City
Zürich
ZIP/Postal Code
8002
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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