The purpose of this study is to evaluate whether the mobile-phone based patient support has an impact on the adherence and persistence of ticagrelor treatment or on lifestyle changes that will have a positive impact on the cardiovascular risk factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
174
The mobile-phone based patient support (investigational medical device) is a stand-alone software product used on the patients' own smart phone and used in addition to medical treatment.
All patients (active and control group) participating in the study will report their daily use of ticagrelor in an e-diary which will be initiated on all study patients' smart phones.
Research Site
Gothenburg, Sweden
Research Site
Jönköping, Sweden
Research Site
Köping, Sweden
Research Site
Linköping, Sweden
Non-adherence Score
The primary composite endpoint was defined as a non-adherence score based on the combination of adherence failure events and treatment gaps. Adherence failure events were defined as 2 missed doses during an observation cycle of up to 7 days. The first registered missed dose of ticagrelor in the e-diary initiated an observation cycle of 1 week. If a second missed dose was registered during the week, this was considered an adherence failure event. The third missed dose initiated a new observation cycle, and the process restarted. If the second missed dose was registered after more than 1 week, this was not defined as an adherence failure event, but initiated a new observation cycle. Treatment gaps were defined as patient reported gaps of 4 consecutive doses.
Time frame: 6 months
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Research Site
Nyköping, Sweden
Research Site
Örebro, Sweden
Research Site
Stockholm, Sweden
Research Site
Sundsvall, Sweden
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
...and 3 more locations