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Collabree: An Intervention to Improve the Regularity of Medication Intake

Primary Purpose

Hypertension, Medication Adherence

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Collabree Mobile Phone Application Medication Adherence Booster (simplified version)
Collabree Mobile Phone Application Medication Adherence Booster
Sponsored by
Collabree AG
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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent as documented by signature
  2. Over 18 years of age at date of randomization
  3. Primary or secondary arterial hypertension
  4. Patient in an outpatient clinical setting
  5. Prescribed a therapy consisting of 4 or more tablets taken per day
  6. Stable medication regime that patient has been taking for at least 4 weeks
  7. Participant administers their own medications
  8. Participant owns a smartphone with a data plan or constant internet access during the study visits and at home to use the application
  9. Minimal required smartphone operating system is iOS 12 and Android 8 (Oreo)
  10. Adequate communication in German or Swiss-German (all study documentation will only be set to the German language).

Exclusion Criteria:

  1. Cognitive impairment that limits ability to understand and complete questionnaires
  2. Ongoing evaluation for secondary forms of hypertension
  3. 3. Changes in the participant's medication treatment plan after the baseline visit during the intervention period, unless due to a diagnosis of symptomatic hypotension (in-clinic blood pressure below 110/60 mmHg and symptoms of orthostasis or dizziness) or stage 2 hypertension (in-clinic blood pressure > 160/100 mmHg); after the endpoint (day 90) visit, a change in the treatment plan will be permitted
  4. Uncontrolled hypertension (in-clinic blood pressure > 180/110 mmHg)
  5. Inability to operate a mobile phone and the Collabree application
  6. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  7. Pregnancy or intention to become pregnant in next 6 months
  8. Enrollment of the Sponsor or Investigator, their family members, employees and other dependent persons
  9. Participation in another clinical trial
  10. Physician-estimated life expectancy of less than 6 months

Sites / Locations

  • University Hospital BaselRecruiting

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 and standard care.

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

Patients will not receive the Collabree application and will continue to receive standard care.

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 medication events.

Secondary Outcome Measures

Medication adherence (3 group comparison)
Mean change from baseline in medication adherence (monitored by medication events) 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.
Blood pressure
Linear change in systolic and diastolic blood pressure (24h ABPM and in-clinic blood pressure measurement) across time from baseline to follow-up as assessed with a linear mixed regression model. This linear change will then be compared for the intervention Group A and intervention Group B relative to the control group.

Full Information

First Posted
January 12, 2021
Last Updated
February 7, 2023
Sponsor
Collabree AG
Collaborators
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04708756
Brief Title
Collabree: An Intervention to Improve the Regularity of Medication Intake
Official Title
Collabree: A Targeted Behavioral Economics-based Intervention to Improve Medication Adherence in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Collabree AG
Collaborators
University Hospital, Basel, Switzerland

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 a clinical study to improve medication adherence among patients with hypertension in Switzerland. Adult men and women who suffer from high blood pressure and have been prescribed a therapy consisting of at least 4 tablets per day 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. The study will also investigate if the use of Collabree can help lower blood pressure. The study consists of 4 visits that take place during a 90-day adherence promotion program plus a 90-day follow-up period. There is also a screening visit before the study to determine whether the participants qualify for the study. The visits are carried out at the University Hospital Basel. Each visit lasts about 1-2 hours. During the visits, blood pressure is measured in the clinic and also through 24-hour ambulatory blood pressure monitoring (ABPM). 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. All participants will receive a box for storing their antihypertensive medication. This box serves as a system for measuring medication intake as it records the time the box is opened and closed. Standard care will given to all participants.

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 and standard care.
Arm Title
Intervention Group B
Arm Type
Experimental
Arm Description
Patients receive the Collabree mobile phone application with a specific set of functions and standard care.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will not receive the Collabree application and will continue to receive standard care.
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. Patients will receive standard care.
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. Patients will receive standard care.
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 medication events.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Medication adherence (3 group comparison)
Description
Mean change from baseline in medication adherence (monitored by medication events) 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.
Time Frame
90 days
Title
Blood pressure
Description
Linear change in systolic and diastolic blood pressure (24h ABPM and in-clinic blood pressure measurement) across time from baseline to follow-up as assessed with a linear mixed regression model. This linear change will then be compared for the intervention Group A and intervention Group B relative to the control group.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent as documented by signature Over 18 years of age at date of randomization Primary or secondary arterial hypertension Patient in an outpatient clinical setting Prescribed a therapy consisting of 4 or more tablets taken per day Stable medication regime that patient has been taking for at least 4 weeks Participant administers their own medications Participant owns a smartphone with a data plan or constant internet access during the study visits 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: Cognitive impairment that limits ability to understand and complete questionnaires Ongoing evaluation for secondary forms of hypertension 3. Changes in the participant's medication treatment plan after the baseline visit during the intervention period, unless due to a diagnosis of symptomatic hypotension (in-clinic blood pressure below 110/60 mmHg and symptoms of orthostasis or dizziness) or stage 2 hypertension (in-clinic blood pressure > 160/100 mmHg); after the endpoint (day 90) visit, a change in the treatment plan will be permitted Uncontrolled hypertension (in-clinic blood pressure > 180/110 mmHg) 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. Pregnancy or intention to become pregnant in next 6 months Enrollment of the Sponsor or Investigator, their family members, employees and other dependent persons Participation in another clinical trial Physician-estimated life expectancy of less than 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anjali Raja Beharele, PhD
Phone
+41 (0)78 973 7756
Email
anjali.rajabeharelle@collabree.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Kurz
Phone
+41 (0)79 963 51 52
Email
pascal.kurz@collabree.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Burkard, MD, ISHF
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thilo Burkard, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Collabree: An Intervention to Improve the Regularity of Medication Intake

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