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CompletedNCT04708756Updated Mar 18, 2026

Collabree: An Intervention to Improve the Regularity of Medication Intake

An interventional study of Collabree Mobile Phone Application Medication Adherence Booster (simplified version) and Collabree Mobile Phone Application Medication Adherence Booster in Hypertension and Medication Adherence, sponsored by Collabree AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Collabree AG · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Medication Adherence

Keywords

  • Digital Health
  • Behavioral Change
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 181 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

This is the only study on the registry with Collabree AG as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    Intervention Group A

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

    Behavioral: Collabree Mobile Phone Application Medication Adherence Booster

  • Experimental
    Intervention Group B

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

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

  • No intervention
    Control Group

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

Interventions

  • BehavioralCollabree 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.

  • BehavioralCollabree 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. Patients will receive standard care.

06

What researchers measure

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 medication events.

    Time frame: 90 days

Secondary outcomes

  1. 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.

    Time frame: 90 days

  2. 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.

    Time frame: 90 days

  3. 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.

    Time frame: 90 days

  4. 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.

    Time frame: 180 days

07

Study locations

1 site
  • University Hospital Basel
    Basel, Basel 4031, Switzerland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04708756
Lead sponsor
Collabree AG
Collaborators
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Jan 14, 2021
Start date
Jul 1, 2021
Primary completion
Nov 4, 2024
Completion
Feb 3, 2025
Last update
Mar 18, 2026

Study contacts

Thilo Burkard, MD, ISHF
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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