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

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.)

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Dementia; Mental Health Disorder
• Intervention / Treatment: Device: 12 lead ECG monitoring; Device: 6 lead ECG monitoring; Device: Hand held ECG monitoring

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS7 9TF
      • Recruiting
      • Leeds Partnership NHS Foundation Trust
      • Contact: George Crowther, MBChB PhD; Email: georgecrowther@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults, 18 and over, attending memory clinic with a new diagnosis of Alzheimer's, Mixed or Lewy Body type dementia indicated for AChIE treatment, will be invited to participate. These are patients who would be indicated to have an ECG as part of routine practice.

All general adult and old age inpatient wards in Leeds and York Partnership NHS Foundation Trust.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG monitoring	12 lead, 6 lead and handheld ECG device monitoring will be undertaken.	45 minutes

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Collaborators: Leeds and York Partnership NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2020
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Mental Disorders
• Other Study ID Numbers: EVALECG MEPS Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No