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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01874262
First received: May 29, 2013
Last updated: January 25, 2016
Last verified: January 2016
Results First Received: November 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Myocardial Infarction
Interventions: Device: Mobile-phone based patient support
Device: e-diary

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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).

Participant Flow:   Overall Study
    E-diary + Mobile-phone Based Patient Support     E-diary  
STARTED     91     83  
Not Correctly Randomised     2     0  
Not Included Due to Tehnical Issues     3     3  
COMPLETED     86     80  
NOT COMPLETED     5     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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).
Total Total of all reporting groups

Baseline Measures
    E-diary + Mobile-phone Based Patient Support     E-diary     Total  
Number of Participants  
[units: participants]
  86     80     166  
Age, Customized  
[units: years]
Mean (Standard Deviation)
  56.8  (8.0)     58.4  (8.6)     57.5  (8.3)  
Gender  
[units: years]
     
Female     15     17     32  
Male     71     63     134  



  Outcome Measures

1.  Primary:   Non-adherence Score   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Susanna Jerström
Organization: AstraZeneca
phone: +46 8 553 260 00



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01874262     History of Changes
Other Study ID Numbers: ME-CV-1301
Study First Received: May 29, 2013
Results First Received: November 17, 2015
Last Updated: January 25, 2016
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency