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

Myocardial Infarction Clinical Trial

— SUPPORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874262
• Other study ID #: ME-CV-1301
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: January 25, 2016
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• Mobile-phone based patient support
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.
• e-diary
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.

Locations

Country	Name	City	State
Sweden	Research Site	Goteborg
Sweden	Research Site	Jonkoping
Sweden	Research Site	Koping
Sweden	Research Site	Linkoping
Sweden	Research Site	Nykoping
Sweden	Research Site	Orebro
Sweden	Research Site	Stockholm
Sweden	Research Site	Sundsvall
Sweden	Research Site	Umea
Sweden	Research Site	Uppsala
Sweden	Research Site	Varberg
Sweden	Research Site	Vasteras
Sweden	Research Site	Vaxjo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No