Trial Outcomes & Findings for A Study to Evaluate the Use of Mobile-phone Based Patient Support in Patients Diagnosed With Myocardial Infarction (NCT NCT01874262)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

174 participants

Primary outcome timeframe

6 months

Results posted on

2016-02-22

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	91	83
Overall Study Not Correctly Randomised	2	0
Overall Study Not Included Due to Tehnical Issues	3	3
Overall Study COMPLETED	86	80
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E-diary + Mobile-phone Based Patient Support n=86 Participants 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 n=80 Participants 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 n=166 Participants Total of all reporting groups
Age, Customized	56.8 years STANDARD_DEVIATION 8.0 • n=5 Participants	58.4 years STANDARD_DEVIATION 8.6 • n=7 Participants	57.5 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	63 Participants n=7 Participants	134 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	E-diary + Mobile-phone Based Patient Support n=85 Participants 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 n=77 Participants 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).
Non-adherence Score	16.6 Non-adherence score Standard Deviation 42.9	22.8 Non-adherence score Standard Deviation 41.3

Adverse Events

E-diary + Mobile-phone Based Patient Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

E-diary

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susanna Jerström

AstraZeneca

Phone: +46 8 553 260 00

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER