Reveal and Carelink (Real Care): Does using remote monitoring in combination with Implantable Loop Recorders reduce the time to diagnosis?

ISRCTN	ISRCTN72340423
DOI	https://doi.org/10.1186/ISRCTN72340423
Protocol serial number	Real Care - MED-248-201
Sponsor	County Durham and Darlington NHS Foundation Trust (UK)
Funder	County Durham and Darlington NHS Foundation Trust (UK) - Real Care - MED-248-201 - CDDFT Springboard Grant

Submission date: 05/03/2014
Registration date: 28/04/2014
Last edited: 21/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
There are many reasons why people collapse or suffer from palpitations (pounding or racing of the heart). After full investigation the cause of the patient's symptoms may remain unexplained or there may be suspicion but not evidence that it is due to an irregularity in the rhythm of the heart. If the heart is going too slowly or too fast, it could be the reason for the symptom. A patient's doctor may suggest prolonged monitoring of the heart by means of an implantable loop recorder (ILR). ILRs are small diagnostic devices for monitoring and recording the heart's electrical signals/electrocardiographs (ECGs) for extended periods of time. The device can be fixed for up to 36 months in some cases. ILRs are implanted under local anaesthetic just beneath the skin, most often on the left side of the chest. The aim of this study is to compare traditional methods of implantable loop recorder follow-up within the County Durham and Darlington NHS Foundation Trust hospitals with a newly available method that means patients can be followed up from their own home.

Who can participate?
The study is available to all patients who receive a Medtronic ILR and are over 18 years of age with access to a landline telephone.

What does the study involve?
Patients are randomly allocated to one of two groups: experimental group patients receive the remote monitoring equipment and those in the control group receive usual care. The research will identify how well patients accept the remote monitoring system and if it can improve our time to diagnosis.

What are the possible benefits and risks of participating?
The benefits of this study lay in ensuring that future implantable loop recorder patients receive the best possible care and a diagnosis is reached in the safest and most efficient way. There are no perceived additional risks involved with taking part in the study. However, if any potential risks are highlighted throughout the course of the study, participants would be informed and asked if they would like to continue to take part or leave the study.

Where is the study run from?
The study is run from hospitals within County Durham and Darlington NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
The study will recruit patients between November 2013 and November 2015 and will follow patients up for two years with the last patient leaving the study in November 2017.

Who is funding the study?
County Durham and Darlington NHS Foundation Trust (UK).

Who is the main contact?
Mr Gareth Pounds
gareth.pounds@cddft.nhs.uk

Contact information

Mr Gareth Pounds
Scientific

Cardiac and Respiratory Services
Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom

Phone	+44 (0)1325 743154
Email	gareth.pounds@cddft.nhs.uk

Study information

Primary study design	Interventional
Study design	Single-centre prospective randomised clinician-blinded, using consecutive, fully informed patients. Data analysis to be carried out on an intention-to-treat basis.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Reveal and Carelink (Real Care): Does using remote monitoring in combination with Implantable Loop Recorders reduce the time to diagnosis? A randomised controlled trial
Study acronym	Real Care
Study objectives	Utilising Carelink remote monitoring for County Durham and Darlington NHS Foundation Trust implantable loop recorder patients can reduce the time taken to reach a diagnosis of whether there is a cardiac cause for their symptoms or not, when compared to traditional in-office follow-up.
Ethics approval(s)	1. Durham University's School of Medicine, Pharmacy and Health Sub-Ethics Committee, 28/08/2013, Ref. ESC2/2013/08 2. Health Research Authority NRES Committee North East - Sunderland - Ref. 13/NE/0297
Health condition(s) or problem(s) studied	Syncope / TLoc and Palpitations - Cardiovascular Medicine
Intervention	Experimental Group - Addition of Carelink remote monitoring equipment provided by Medtronic Inc. Data from implantable loop recorder to be viewed fortnightly. Patients in the Control Group will follow the standard care pathway. Patients will spend a maximum of 2 years in the study.
Intervention type	Other
Primary outcome measure(s)	Time to patient diagnosis or non-cardiac outcome within the 24-month follow-up period.
Key secondary outcome measure(s)	1. Which follow-up method promotes the least device memory saturation 2. Are more patients diagnosed via automated recordings or manual recordings 3. Impact in terms of time and resources required of running remote monitoring clinics within CDDFT hospitals Patients will be reviewed at baseline (1 month post implant/enrolment) then 6 monthly or if symptoms occur for control group patients and fortnightly or if symptoms occur for experimental group patients. A participant is considered to have a cardiac diagnosis if they are treated for a cardiac problem that could be the cause of their symptoms, such as asystole, bradycardia or tachycardia other than sinus tachycardia. Treatment could be in the form of medication, a cardiac device (pacemaker, ICD or CRT) or any other form of cardiac rate or rhythm management therapy. Participants may receive a non-cardiac diagnosis as the cause for their symptoms; this is considered to be the case if a participant makes a manual recording whilst symptomatic on two or more occasions. Finally, previous data suggests that there will be a small number of participants that will not have any symptoms during the 24-month follow-up period, these participants will receive no diagnosis.
Completion date	20/11/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Implanted with a Medtronic Reveal DX or XT ILR 2. Over 18 years of age 3. Are themselves cognitively capable of consenting 4. Have the ability, or have a willing and appropriate adult to use any equipment and comply with the control and Carelink pathway 5. Are able to communicate using, or understand instructions given in, English
Key exclusion criteria	1. Patients that do not have access to a landline telephone 2. If they have documented cognitive impairment that means that they are unable to consent for themselves 3. Do not have the ability or a willing and appropriate adult to comply with the use of any equipment or they are unable to follow the control and Carelink care pathways 4. Patients that cannot communicate using, or understand instructions given in, English
Date of first enrolment	20/11/2013
Date of final enrolment	20/11/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Darlington Memorial Hospital

Darlington
DL3 6HX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Thesis results			21/05/2021	No	No

Editorial Notes

21/05/2021: Publication reference added.