Clinical trial NCT01874262: A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction
Official title: A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction - SUPPORT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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:

1. Provision of written patient informed consent.
2. Patients must have a smart phone at their disposal and use it on a daily basis.
3. 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.
4. Ability to read, understand and write Swedish.

Exclusion Criteria:

1. 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.
2. 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.
3. Patients those are pregnant or lactating.
4. 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).

Primary outcomes:
measure: Non-adherence Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Research Site
city: Jonkoping
country: Sweden
facility: Research Site
city: Koping
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Nykoping
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Varberg
country: Sweden
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
city: Vaxjo
country: Sweden
facility: Research Site
Study officials:
affiliation: Kardiologkliniken, Akademiska Sjukhuset Uppsala
name: Christoph Varenhorst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: