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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01874262
First received: May 29, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Myocardial Infarction
Device: Mobile-phone based patient support
Device: e-diary

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction - SUPPORT

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    The primary outcome will be a composite endpoint consisting of adherence failure events and treatment gaps:

    Adherence failure events are defined as more than 14% missed doses during an observation cycle of 7 days. The first missed dose of ticagrelor initiates an observation cycle of 1 week. If a second missed dose is registered within this week an adherence failure event is registered. The third missed dose initiates a new observation cycle, and the process restarts.

    Treatment gaps are defined as patient reported gaps of more than 4 consecutive doses during the participation in the study.



Estimated Enrollment: 160
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874262

Locations
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, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Christoph Varenhorst, MD, PhD Kardiologkliniken, Akademiska Sjukhuset Uppsala
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01874262     History of Changes
Other Study ID Numbers: ME-CV-1301
Study First Received: May 29, 2013
Last Updated: July 29, 2014
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014