A mobile app to help patients with hypertension take their medications regularly
Collabree: A Targeted Behavioral Economics-based Intervention to Improve Medication Adherence in Patients With Hypertension
This study is testing a mobile app to help adults with high blood pressure remember to take their medications regularly and see if it can lower their blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Collabree AG Industry-sponsored |
| Locations | 1 site (Basel) |
| Trial ID | NCT04708756 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to enhance medication adherence among patients with hypertension in Switzerland using a mobile application called Collabree. Participants, who are adults prescribed at least four tablets daily for their high blood pressure, will engage in a 90-day program involving four clinic visits and a follow-up period. During these visits, blood pressure will be monitored both in-clinic and through 24-hour ambulatory monitoring. The effectiveness of the app in improving adherence and potentially lowering blood pressure will be evaluated.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with primary or secondary hypertension who are prescribed a stable regimen of four or more medications daily.
Not a fit: Patients with cognitive impairments or those undergoing evaluation for secondary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence and blood pressure control for patients with hypertension.
How similar studies have performed: Other studies have shown promising results in using mobile health applications to improve medication adherence, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Thilo Burkard, MD, ISHF — University Hospital, Basel, Switzerland
- Study coordinator: Anjali Raja Beharele, PhD
- Email: anjali.rajabeharelle@collabree.com
- Phone: +41 (0)78 973 7756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.