Collabree: An Intervention to Improve Medication Adherence
Summary description of the study
This is a clinical study aimed at improving medication adherence in individuals with hypertension. Adult women and men suffering from hypertension who need to take at least 4 pills per day can participate in this study. We want to find out if Collabree, a mobile application that supports users in therapy implementation, is helpful in improving medication adherence. The study will also assess whether the use of Collabree can improve blood pressure control. The study includes 4 visits that will take place over a 90-day intervention program and a 90-day follow-up observation. Additionally, a pre-study appointment is required to check if you are eligible for participation. The visits will be conducted at the University Hospital Basel. Each visit lasts about 1-2 hours. During the visits, blood pressure will be measured in the clinic as well as through 24-hour ambulatory blood pressure monitoring (ABPM). Participants will also fill out questionnaires. Participants will be randomly assigned to one of 3 groups in a 1:1:1 ratio. Two of these groups will receive the Collabree mobile application. All participants will receive a box to store their blood pressure medication. This system monitors medication adherence by documenting the times when the box is opened and closed. Standard care will be provided to all participants.
(BASEC)
Intervention under investigation
In this study, medication adherence will be compared among three groups.
Participants in groups 1 and 2 will participate in a 90-day program to promote medication adherence and a 90-day follow-up observation using the Collabree application. The exact features and use of the mobile application differ for groups 1 and 2. More information will be provided to these participants during the installation of the application on their phone. Participants in group 3 will not receive the Collabree application and will continue to be treated according to their standard treatment.
(BASEC)
Disease under investigation
Primary and secondary hypertension
(BASEC)
1. Diagnosis of primary or secondary arterial hypertension 2. Older than 18 years 3. Prescribed therapy with intake of 4 or more pills per day (BASEC)
Exclusion criteria
1. Cognitive impairment that limits the ability to understand and complete questionnaires or to use the mobile application 2. Ongoing investigation for a secondary form of hypertension 3. Likelihood that the medication plan will be adjusted within 90 days after the study begins (BASEC)
Trial sites
Basel, Bern, Lausanne, Zurich
(BASEC)
Sponsor
not available
Contact
Contact Person Switzerland
Anjali Raja Beharelle
+41 (0)78 973 77 56
anjali.rajabeharelle@cluttercollabree.com(BASEC)
General Information
University Hospital, Basel, Switzerland,
+41 (0)78 973 7756;
anjali.rajabeharelle@cluttercollabree.com(ICTRP)
Scientific Information
University Hospital, Basel, Switzerland,
+41 (0)78 973 7756;
anjali.rajabeharelle@cluttercollabree.com(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
06.04.2021
(BASEC)
ICTRP Trial ID
NCT04708756 (ICTRP)
Official title (approved by ethics committee)
not available
Academic title
Collabree: A Targeted Behavioral Economics-based Intervention to Improve Medication Adherence in Patients With Hypertension (ICTRP)
Public title
Collabree: An Intervention to Improve the Regularity of Medication Intake (ICTRP)
Disease under investigation
Hypertension;Medication Adherence (ICTRP)
Intervention under investigation
Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (simplified version);Behavioral: Collabree Mobile Phone Application Medication Adherence Booster (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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
(ICTRP)
not available
Primary and secondary end points
Medication adherence (ICTRP)
Medication adherence (3 group comparison);Self-reported medication adherence;Self-assessed medication adherence;Blood pressure (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University Hospital, Basel, Switzerland (ICTRP)
Additional contacts
Thilo Burkard, MD, ISHF;Anjali Raja Beharele, PhD;Thilo Burkard, MD, anjali.rajabeharelle@collabree.com, +41 (0)78 973 7756;, University Hospital, Basel, Switzerland, (ICTRP)
Secondary trial IDs
COLLABREE-S (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04708756 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available