Trial Outcomes & Findings for The IPED (Investigation of Palpitations in the ED) Study (NCT NCT02783898)
NCT ID: NCT02783898
Last Updated: 2019-11-19
Results Overview
Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
243 participants
Primary outcome timeframe
90 days
Results posted on
2019-11-19
Participant Flow
243 patients randomised. 1 participant removed after randomisation as did not meet inclusion criteria. 242 patients allocated to arms.
Participant milestones
| Measure |
Study
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
117
|
|
Overall Study
COMPLETED
|
124
|
116
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study
n=125 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=117 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 14 • n=125 Participants
|
39.1 years
STANDARD_DEVIATION 13.5 • n=117 Participants
|
39.6 years
STANDARD_DEVIATION 13.8 • n=242 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=125 Participants
|
63 Participants
n=117 Participants
|
137 Participants
n=242 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=125 Participants
|
54 Participants
n=117 Participants
|
105 Participants
n=242 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
History of presenting episode = Palpitations
|
110 Participants
n=125 Participants
|
109 Participants
n=117 Participants
|
219 Participants
n=242 Participants
|
PRIMARY outcome
Timeframe: 90 daysSymptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.
Outcome measures
| Measure |
Study
n=124 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Number of Participants With Symptomatic Rhythm Detection up to 90 Days
|
69 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 90 daysSymptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care
Outcome measures
| Measure |
Study
n=124 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 daysTime to detection of symptomatic rhythm using a smart phone based event recorder versus standard care
Outcome measures
| Measure |
Study
n=124 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Time to Detection of Symptomatic Rhythm
|
9.5 days
Standard Deviation 16.1
|
42.9 days
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 90 daysTime to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care
Outcome measures
| Measure |
Study
n=124 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Time to Detection of Cardiac Arrhythmia Rhythm
|
9.9 days
Standard Deviation 15.6
|
48 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 90 daysNumber of participants treated or (planned for treatment) for cardiac arrhythmia in participants using a smart phone based event recorder versus standard care
Outcome measures
| Measure |
Study
n=124 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use
Outcome measures
| Measure |
Study
n=125 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Strongly Agree
|
48 Participants
|
—
|
|
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Agree
|
32 Participants
|
—
|
|
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Missing
|
33 Participants
|
—
|
|
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Strongly Disagree
|
4 Participants
|
—
|
|
Number of Participants Finding the AliveCor Heart Monitor Easy to Use
Neutral
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 90 daysFinancial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.
Outcome measures
| Measure |
Study
n=124 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Financial Cost Per Diagnosis of Symptomatic Rhythm
|
474 British pounds
Interval 99.0 to 2697.0
|
1395 British pounds
Interval 0.0 to 4161.0
|
SECONDARY outcome
Timeframe: 90 daysNumber of patients with all cause death and/or major adverse cardiac events (MACE; myocardial infarction, life threatening arrhythmia, insertion of pacemaker or internal cardiac defibrillator, insertion of pacing wire).
Outcome measures
| Measure |
Study
n=124 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 Participants
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Number of Participants With Serious Outcome up to 90 Days
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 90 daysMeasure of questionnaire compliance - Number of participants completing questionnaire
Outcome measures
| Measure |
Study
n=125 Participants
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Number of Participants Completing Questionnaire
Completed questionnaire
|
92 Participants
|
—
|
|
Number of Participants Completing Questionnaire
Not completed
|
33 Participants
|
—
|
Adverse Events
Study
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Study
n=124 participants at risk
All STUDY arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. They will be followed up at 90 days. If a participants allocated to the Study arm, gets an episode of palpitations or pre-syncope and is able to record an AliveCor Heart Monitor ECG during the episode, the participant will email the ECG recorded by the AliveCor app directly to the study team. The study team will review the ECG. If specialist follow-up is not required the study team will inform the participant of this and ask them to arrange general practitioner follow up. If the participant records a serious significant arrhythmia during the study period, the study team will alert the participant immediately and refer them to the cardiac electrophysiology service.
AliveCor Heart Monitor: Smart phone based ECG event recorder
|
Control
n=116 participants at risk
All CONTROL arm participants will receive no other intervention. Participants in both groups will be admitted, referred or discharged by the treating clinician according to current hospital protocols. Participants in both groups will be followed up at 90 days through hospital electronic patient record (EPR) systems and through a standardised written questionnaire and follow-up telephone call including symptoms and contact with medical services, satisfaction and compliance.
|
|---|---|---|
|
Cardiac disorders
Major Adverse Cardiac Events
|
8.9%
11/124 • Number of events 11 • 90 days
|
0.86%
1/116 • Number of events 1 • 90 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place