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

January 25, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • 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, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active group
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.
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.
Device: 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.
PLACEBO_COMPARATOR: The control group
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-adherence Score
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Christoph Varenhorst, MD, PhD, Kardiologkliniken, Akademiska Sjukhuset Uppsala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (ESTIMATE)

June 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-CV-1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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