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

May 29, 2013
July 29, 2014
June 2013
December 2014   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01874262 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Myocardial Infarction
  • 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.
  • 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.
    Interventions:
    • Device: Mobile-phone based patient support
    • Device: e-diary
  • 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.
    Intervention: Device: e-diary
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
December 2014
December 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01874262
ME-CV-1301
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Christoph Varenhorst, MD, PhD Kardiologkliniken, Akademiska Sjukhuset Uppsala
AstraZeneca
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP