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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental | 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. |
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| The control group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile-phone based patient support | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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 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).
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Varenhorst, MD, PhD | Kardiologkliniken, Akademiska Sjukhuset Uppsala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | Sweden | ||||
| Research Site |
Before discharge from the hospital patients diagnosed with myocardial infarction and treated with ticagrelor were offered participation in the study and those that accepted and signed informed consent were randomized into one of the two study groups.
The first participant was enrolled on 30 June 2013 and the last participant completed the study on 11 December 2014. Study participants were randomized from 15 centers in Sweden.
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| ID | Title | Description |
|---|---|---|
| FG000 | E-diary + Mobile-phone Based Patient Support | The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| e-diary | Device | 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. |
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| 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 |
| FG001 | E-diary | In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support). |
| Not Correctly Randomised |
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| Not Included Due to Tehnical Issues |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | E-diary + Mobile-phone Based Patient Support | The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use. |
| BG001 | E-diary | In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Posted | Mean | Standard Deviation | Non-adherence score | 6 months |
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6 months
Only device related events were monitored in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-diary + Mobile-phone Based Patient Support | The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use. | 0 | 0 | 0 | 0 | ||
| EG001 | E-diary | In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support). | 0 | 0 | 0 | 0 |
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An Investigator agrees to provide a copy of the publication to AstraZeneca (AZ) for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanna Jerström | AstraZeneca | +46 8 553 260 00 |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| Male |
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