Collabree: An Intervention to Improve the Regularity of Medication Intake

NCT ID: NCT04708756

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-02-28

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 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.

Conditions

Hypertension; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group A

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

Group Type: EXPERIMENTAL

Collabree Mobile Phone Application Medication Adherence Booster

Intervention Type: BEHAVIORAL

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.

Intervention Group B

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

Group Type: EXPERIMENTAL

Collabree Mobile Phone Application Medication Adherence Booster (simplified version)

Intervention Type: BEHAVIORAL

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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Collabree 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.

Intervention Type: BEHAVIORAL

Collabree 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Collabree AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thilo Burkard, MD, ISHF

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Anjali Raja Beharele, PhD

Role: CONTACT

anjali.rajabeharelle@collabree.com

+41 (0)78 973 7756

Pascal Kurz

Role: CONTACT

pascal.kurz@collabree.com

+41 (0)79 963 51 52

Facility Contacts

Thilo Burkard, MD

Role: primary

Other Identifiers

COLLABREE-S

Identifier Type: -

Identifier Source: org_study_id