A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction

Not Applicable

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT01874262
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-11-17
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Results First Posted: 2016-02-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Non-adherence Score	6 months	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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Vaxjo, Sweden