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

• Conditions: Dementia; Cardiovascular Diseases; Mental Health Disorder
• Interventions: Device: 12 lead ECG monitoring; Device: 6 lead ECG monitoring; Device: Hand held ECG monitoring

• Registration Number: NCT04227418
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-01-24
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mental Health	12 lead ECG monitoring	-
Psychiatric	12 lead ECG monitoring	-
Mental Health	6 lead ECG monitoring	-
Psychiatric	Hand held ECG monitoring	-
Mental Health	Hand held ECG monitoring	-
Psychiatric	6 lead ECG monitoring	-

Primary Outcome Measures

Name	Time	Method
ECG monitoring	45 minutes	12 lead, 6 lead and handheld ECG device monitoring will be undertaken.

Trial Locations

Locations (1)

Leeds Partnership NHS Foundation Trust; 🇬🇧 Leeds, West Yorkshire, United Kingdom