N/A
N=174
A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction
Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01874262 ↗Enrolled (actual)
174
Serious AEs
—
Results posted
Feb 2016
Primary outcome: Primary: Non-adherence Score — 16.6; 22.8 Non-adherence score — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mobile-phone based patient support (Device); e-diary (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-adherence Score |
16.6; 22.8 | 0.025 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Provision of written patient informed consent.
- Patients must have a smart phone at their disposal and use it on a daily basis.
- Female or male aged >18 years, diagnosed with a ST elevation Myocardial Infarction (STEMI) or non ST elevation Myocardial Infarction (NSTEMI) and treated with ticagrelor prior to inclusion into this study and for which the treating physician intend to continue prescribing ticagrelor according to the prescription recommendation.
- Ability to read, understand and write Swedish.
Exclusion Criteria
- Participation in any clinical trial or device study in the last 30 days excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care.
- Patients not suitable for participation based on the investigators judgment for example:
- Patients on treatment with triple antithrombotic treatment.
- Patients on treatment with anticoagulantia.
- Patients accepted/with a plan for thoracic surgery (CABG) or any other elective surgery that cannot be postponed until after study participation.
- Patients with a life expectancy of less than 12 months.
- Patients judged to be unable to follow a structured physical activity program.
- Patients those are pregnant or lactating.
- Patients involved in the planning and/or conduct of the study (applies to AstraZeneca staff and/or staff at the study site and application developer).
Data sourced from ClinicalTrials.gov (NCT01874262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.