A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction
SUPPORT
1 other identifier
interventional
174
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
February 22, 2016
CompletedFebruary 22, 2016
January 1, 2016
1.5 years
May 29, 2013
November 17, 2015
January 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Active group
EXPERIMENTALThe 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.
The control group
PLACEBO COMPARATORIn 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.
Interventions
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.
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 Criteria
You may qualify if:
- Provision of written patient informed consent.
- Patients must have a smart phone at their disposal and use it on a daily basis.
- Ability to read, understand and write Swedish.
You may not qualify if:
- 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.
- 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.
- Patients those are pregnant or lactating.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (13)
Research Site
Gothenburg, Sweden
Research Site
Jönköping, Sweden
Research Site
Köping, Sweden
Research Site
Linköping, Sweden
Research Site
Nyköping, Sweden
Research Site
Örebro, Sweden
Research Site
Stockholm, Sweden
Research Site
Sundsvall, Sweden
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
Research Site
Varberg, Sweden
Research Site
Vaxjo, Sweden
Research Site
Västerås, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susanna Jerström
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Varenhorst, MD, PhD
Kardiologkliniken, Akademiska Sjukhuset Uppsala
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2013
First Posted
June 11, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 22, 2016
Results First Posted
February 22, 2016
Record last verified: 2016-01