HypertensionNCT04708756
Collabree: An Intervention to Improve the Regularity of Medication Intake
A study testing Collabree Mobile Phone Application Medication Adherence Booster (simplified version) and Collabree Mobile Phone Application Medication Adherence Booster in people with Hypertension and Medication Adherence, run by Collabree AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Medication Adherence
- What is being tested?
- Collabree Mobile Phone Application Medication Adherence Booster (simplified version) and Collabree Mobile Phone Application Medication Adherence Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2021to 3 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collabree: A Targeted Behavioral Economics-based Intervention to Improve Medication Adherence in Patients With Hypertension
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.
Read more
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.
- Conditions
- Hypertension, Medication Adherence
- Being tested
- Collabree Mobile Phone Application Medication Adherence Booster (simplified version), Collabree Mobile Phone Application Medication Adherence Booster
- Keywords
- Digital Health, Behavioral Change
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collabree Mobile Phone Application Medication Adherence Booster (simplified version)Behavioural
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.
Collabree Mobile Phone Application Medication Adherence BoosterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group A | Experimental | Patients receive the Collabree mobile phone application with a specific set of functions and standard care. Receives: 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 and standard care. Receives: Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (simplified version) |
| Control Group | No intervention | Patients will not receive the Collabree application and will continue to receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (4)
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jul 2021
- Primary completion4 Nov 2024
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collabree AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Thilo Burkard, MD, ISHF, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708756
- Sponsor's protocol ID
- COLLABREE-S
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collabree: A Targeted Behavioral Economics-based Intervention to Improve Medication Adherence in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04708756
- Acronym / sponsor ID
- COLLABREE-S
- Conditions
- Hypertension, Medication Adherence
- Keywords
- Digital Health, Behavioral Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Collabree AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group A | Experimental | Behavioral: Collabree Mobile Phone Application Medication Adherence BoosterPatients receive the Collabree mobile phone application with a specific set of functions and standard care. |
| Intervention Group B | Experimental | Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (simplified version)Patients receive the Collabree mobile phone application with a specific set of functions and standard care. |
| Control Group | No intervention | –Patients will not receive the Collabree application and will continue to receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. Patients will receive standard care. | Behavioural | Intervention Group B |
| Collabree Mobile Phone Application Medication Adherence BoosterPatients 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. | Behavioural | Intervention Group A |
Primary outcome
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 medication events.
4 secondary outcomes
Medication adherence (3 group comparison)
Time frame: 90 days
Self-reported medication adherence
Time frame: 90 days
Self-assessed medication adherence
Time frame: 90 days
Blood pressure
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thilo Burkard, MD, ISHF principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collabree Mobile Phone Application Medication Adherence Booster (simplified version) and Collabree Mobile Phone Application Medication Adherence Booster in people with Hypertension and Medication Adherence, run by Collabree AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.