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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group A | Experimental | Patients receive the Collabree mobile phone application with a specific set of functions and standard care. |
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| Intervention Group B | Experimental | Patients receive the Collabree mobile phone application with a specific set of functions and standard care. |
|
| Control Group | No Intervention | Patients will not receive the Collabree application and will continue to receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collabree Mobile Phone Application Medication Adherence Booster (simplified version) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | Difference between intervention Group A and the control group in mean medication adherence at endpoint (i.e. the endpoint visit at 90 days) as measured by medication events. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence (3 group comparison) | Mean change from baseline in medication adherence (monitored by medication events) at endpoint for the intervention Group A vs. intervention Group B relative to the control group. | 90 days |
| Self-reported medication adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thilo Burkard, MD, ISHF | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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|
| Collabree Mobile Phone Application Medication Adherence Booster | 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. |
|
Mean change from baseline in in-app medication adherence (defined as the number of medications self-reported as "taken" during the intervention period of 90 days divided by the number of prescribed medications listed in the in-app medication plan in that same time period) at endpoint for the intervention Group A vs. intervention Group B relative to the control group. |
| 90 days |
| Self-assessed medication adherence | Mean change from baseline in the score on the Hill-Bone Scale (German version) questionnaire on medication adherence for the intervention Group A vs. intervention Group B relative to the control group at endpoint. | 90 days |
| Blood pressure | Linear change in systolic and diastolic blood pressure (24h ABPM and in-clinic blood pressure measurement) across time from baseline to follow-up as assessed with a linear mixed regression model. This linear change will then be compared for the intervention Group A and intervention Group B relative to the control group. | 180 days |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |