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An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry

Sponsor
The Leeds Teaching Hospitals NHS Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT04227418
Collaborator
Leeds and York Partnership NHS Foundation Trust (Other)
1,500
Enrollment
1
Location
19.2
Anticipated Duration (Months)
78
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acetylcholinesterase inhibitors and antipsychotics are drugs commonly prescribed in psychiatry, the former for dementia and the latter for acute and chronic psychotic illness. Both can cause cardiac arrhythmia therefore 12 lead ECG's are recommended before prescribing. The test is often difficult to obtain however, leading to either patients being inconvenienced or drugs prescribed without the test. There are two parts of this study, but both examine the utility of single lead ecg monitoring, one in the memory clinic and the other in inpatient psychiatry wards. The aim to to evaluate the safety and efficacy of the handheld ecg versus the 12 lead and 6 lead ecg, and whether the handheld ecg can be used to screen for ecg abnormalities that would generally lead to a caution or contra-indication for acetylcholinesterase inhibitors and anti-psychotic medication.

Patients will either be recruited from the outpatient memory clinic or in patient psychiatry wards. Following informed consent baseline demographic data will be collected, and patients will undergo a 12 lead and 6 lead ECG as well as a rhythm strip using the handheld device. Data from this point will be annonymised for future analysis. The psychiatrists ECG report will also be recorded, and a subset of patients will undergo an echocardiogram (to see what proportion of patients with psychiatric disorders have structural heart disease.)

Condition or Disease Intervention/Treatment Phase
  • Device: 12 lead ECG monitoring
  • Device: 6 lead ECG monitoring
  • Device: Hand held ECG monitoring

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Psychiatry
Actual Study Start Date :
Jan 24, 2020
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Mental Health

Device: 12 lead ECG monitoring
Rate, Rhythm, QTc and PR interval will be assessed

Device: 6 lead ECG monitoring
Rate, Rhythm, QTc and PR interval will be assessed

Device: Hand held ECG monitoring
Handheld ECG machines are portable, inexpensive, hand held devices that provide a 'real-time' rhythm strip, equivalent to lead I or II on a 12 lead machine, depending on how the device is held. The rhythm strip is displayed on a computer tablet or mobile phone, and are compatible with both android and iPhone platforms. To perform the test the patient places their fingers/thigh, or alternatively the device can be placed directly on the patient's chest. The process does not require the patient to be exposed, can be done in a seated position (negating the need an examination couch) and their ease of use and portability means they could be readily used in memory clinics or community settings.
Other Names:
  • AliveCor ECG device

    		•
    Psychiatric

    Device: 12 lead ECG monitoring
    Rate, Rhythm, QTc and PR interval will be assessed

    Device: 6 lead ECG monitoring
    Rate, Rhythm, QTc and PR interval will be assessed

    Device: Hand held ECG monitoring
    Handheld ECG machines are portable, inexpensive, hand held devices that provide a 'real-time' rhythm strip, equivalent to lead I or II on a 12 lead machine, depending on how the device is held. The rhythm strip is displayed on a computer tablet or mobile phone, and are compatible with both android and iPhone platforms. To perform the test the patient places their fingers/thigh, or alternatively the device can be placed directly on the patient's chest. The process does not require the patient to be exposed, can be done in a seated position (negating the need an examination couch) and their ease of use and portability means they could be readily used in memory clinics or community settings.
    Other Names:
  • AliveCor ECG device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ECG monitoring [45 minutes]

      12 lead, 6 lead and handheld ECG device monitoring will be undertaken.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Any patient attending the memory clinic Any patient admitted to the acute psychiatric ward requiring antipsychotic medication

    Exclusion Criteria:

    Patients who lack capacity and do not have a personal consultee to provide assent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Leeds Partnership NHS Foundation Trust Leeds West Yorkshire United Kingdom LS7 9TF

    Sponsors and Collaborators

    • The Leeds Teaching Hospitals NHS Trust
    • Leeds and York Partnership NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Leeds Teaching Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04227418
    Other Study ID Numbers:
    • EVALECG MEPS Study
    First Posted:
    Jan 13, 2020
    Last Update Posted:
    Feb 11, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Mental Disorders

    Study Results

    No Results Posted as of Feb 11, 2020