Condition category
Surgery
Date applied
29/03/2019
Date assigned
05/04/2019
Last edited
12/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
DREAM Path is a study assessing acceptability of remote monitoring, in a group of patients undergoing major surgery. The purpose of the DREAM Path study is to evaluate how well patients comply with the use of a group of smart devices to fill out questionnaires and self-measure clinical observations. We will also evaluate if remote monitoring using questionnaires and clinical observations has a relationship with hospital admissions.
We are investigating whether patients will be able to use simple devices to measure clinical observations and fill out questionnaires after going home following major surgery. A set of devices used together will be referred to as the Home And Locally Observed (HALO) kit.
Patients who go home after major surgery are often at risk of complications after discharge from hospital, and usually present to their GP or hospital if they feel unwell. In DREAM Path, we will be testing if patients will be able to use a number of devices to self-measure the observations we usually take in hospital wards, and fill out a short questionnaire. We will also be exploring whether data we collect from these self-measurements has any link with hospital re-admissions or unplanned GP visits. All recordings will be anonymised to maintain your confidentiality and therefore patient identifiable details will not be recorded.

Who can participate?
Anyone over 18 years of age who is scheduled to undergo or recently undergone major intra-cavity surgery.

What does the study involve?
After your surgery, a member of the research team will provide you with the HALO kit before you are discharged from hospital. If you are recruited at the pre-assessment clinic before your surgery, a member of the trial team may ask you some questions about your medical history.
The study period is the first 30 days after you are discharged from hospital following surgery. During the study period, you will be asked to do the following:
1. Wear an Apple Watch or similar device continuously, with up to an hour for charging daily during which the device will not be used
2. Check clinical observations such as blood pressure, heart rate, blood oxygen level etc twice a day (after waking up and before bedtime)
3. Answer a short questionnaire once a day (in the morning)
At the end of the study interview, a short interview will be conducted asking about your experience in the study and any hospital or GP visits during the monitoring period. Issued devices will be collected from you at this time.

What are the possible benefits and risks of participating?
The information learned from this study may help us to improve ways to improve surgical care in the future. The results of this study will help us to design new ways to monitor patients undergoing major surgery. There are no disadvantages or risks in taking part in this study as it is an observational study and your treatment would be standard of care.

Where is the study run from?
University College London Hospital

When is the study starting and how long is it expected to run for?
November 2018 to August 2019

Who is funding the study?
Urology Foundation, UK
St Peter’s Trust for Kidney Bladder & Prostate Research, UK

Who is the main contact?
Pramit Khetrapal, p.khetrapal@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pramit Khetrapal

ORCID ID

http://orcid.org/0000-0001-8769-5797

Contact details

Division of Surgery & Interventional Science
University College London
3rd floor Charles Bell House
43-45 Foley Street
London
W1W 7TS
United Kingdom
020 7679 9060
p.khetrapal@ucl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS Project ID: 244239

Study information

Scientific title

Domiciliary recovery after medicalisation Pathway

Acronym

DREAMPath

Study hypothesis

The overarching aim of the study is to test the feasibility of using smart technology to collect physiological and Patient Reported Outcome Measures (PROMs) in patients following discharge from hospital after major intra-cavity surgery.

Ethics approval

Approved 28/08/2018, South West - Cornwall & Plymouth Research Ethics Committee (Rooms 2/3, Tamar Science Park, Plymouth, PL6 8BX; 0207 104 8059; nrescommittee.southwest-cornwall-plymouth@nhs.net), ref: 18/SW/0206

Study design

Multi-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Home

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

Major surgery

Intervention

This is a prospective observational study to assess patient compliance with smart technology devices - the Home and locally observed (HALO) kit. The study will recruit patients undergoing any major intra-cavity surgery which is associated with a re-admission rate of >15% within 30 days of surgery, or >20% in the first 90 days of surgery.
The HALO consists of a sphygmomanometer, peripheral oximeter, wrist-worn tracker with heart-rate monitor and pedometer, thermometer and a cellular broadband device.
Patients will be issued a HALO kit before discharge from hospital, and will be monitored remotely for 4 weeks. Patients will be instructed to wear the tracker continuously, and shown how to measure blood pressure, and temperature twice daily – morning and evening. Additionally, they will be asked to complete a QoR15 once daily.
The HALO kit is designed to be used with a cellular broadband device, such as a 4G-capable mobile phone, which can be used to complete questionnaires electronically. The broadband device remotely uploads data to an anonymised database. Patients will be registered and provided with a trial ID to ensure all transmitted data is anonymised. Patients will be contacted via telephone to confirm activation of the system. At time of consent, patients will be informed that the data collected will not be reviewed for clinical decision-making and that the all data is anonymised. Re-admissions and other engagement with healthcare such as GP visits, A&E visits will be collected as ‘events’. Post-operative complications will be recorded as per the Clavien-Dindo (CD) Classification, and the Post-operative morbidity score (POMS). An exploratory study to understand whether there is a relation between measured physical parameters and healthcare events will be conducted. Upon completion of the study, patients will be asked to return the devices, and information about unplanned healthcare events and adverse events will be collected.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Patient compliance with wearable and interactive smart technology in the 4 weeks following discharge from hospital after major intracavity surgery. Compliance will be defined as completion of 70% of daily PROM questionnaires, or wearing the wrist-worn trackers for at least 10 hours per day for the study duration

Secondary outcome measures

1. To explore the relation between unplanned healthcare events and physiological measurements and PROMs in the post-discharge setting for patients undergoing major surgery.
2. To explore the correlation between PROMs (QoR15) and physiological measures (wrist-worn-device tracking) in patients in the post-discharge setting measured daily.

(Physiological measures collected will be blood pressure, pulse oximetry, temperature twice a day, as well as continuous monitoring of heart rate and physical activity through the wrist-worn wearable device.)

Overall trial start date

29/11/2018

Overall trial end date

01/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 18 years of age
2. Scheduled to undergo or recently undergone major intra-cavity surgery with a re-admission rate of >15% within 30 days, or >20% within 90 days
3. Able to give informed written consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Deemed unfit for surgery
2. Unable or unwilling to comply with remote monitoring for any reason
3. Unable or unwilling to fill in a questionnaire in English

Recruitment start date

30/11/2018

Recruitment end date

01/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospital
University College Hospital 235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 20 3447 5199
randd@uclh.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Urology Foundation

Alternative name(s)

TUF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

St Peter’s Trust for Kidney Bladder & Prostate Research

Alternative name(s)

SPT

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in peer reviewed scientific journals and dissemination of the results at conference presentations and appropriate websites.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/08/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/04/2019: Internal review. 05/04/2019: The participant information sheet has been uploaded as an additional file.