Status:
RECRUITING
Collabree: An Intervention to Improve the Regularity of Medication Intake
Lead Sponsor:
Collabree AG
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Hypertension
Medication Adherence
Eligibility:
All Genders
18+ years
Phase:
NA
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 consis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04708756
Start Date
July 1 2021
End Date
February 1 2025
Last Update
February 9 2024
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031