Collabree: An Intervention to Improve the Regularity of Medication Intake

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    180
  • sponsor
    Collabree AG
Updated on 15 May 2022
hypertension
antihypertensive drugs
ambulatory blood pressure monitoring
24-hour ambulatory blood pressure monitoring

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.

Details
Condition Hypertension, Medication Adherence
Treatment Collabree Mobile Phone Application Medication Adherence Booster (simplified version), Collabree Mobile Phone Application Medication Adherence Booster
Clinical Study IdentifierNCT04708756
SponsorCollabree AG
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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