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

AstraZeneca

Status: Completed

Conditions: Myocardial Infarction

Treatments: Device: Mobile-phone based patient support; Device: e-diary

Study type: Interventional

Funder types: Industry

Identifiers

NCT01874262

ME-CV-1301

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

174 participants in 2 patient groups, including a placebo group

Active group

Experimental group

Description:

The software application used on the patients' smart phones in the active group, will contain both the e-diary and the mobile-phone based patient support. Patients will receive feedback by the mobile-phone based support not only on the data they enter into the mobile-phone based patient support but also on their reported daily ticagrelor use.

Treatment:

Device: Mobile-phone based patient support

Device: e-diary

The control group

Placebo Comparator group

Description:

In this group the patients will have access to the e-diary only, in which they will report their daily use of ticagrelor. The patients in the control group will not receive any feed-back.

Treatment:

Device: e-diary