Condition category
Respiratory
Date applied
17/11/2014
Date assigned
12/01/2015
Last edited
21/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a term used to describe a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease. It is estimated that up to one in four people may develop COPD in their lifetime. Sufferers often face disabling breathlessness which leads to a vicious cycle of reduced activity, social isolation and depression. Around the time of an exacerbation (worsening of the condition) resulting in a hospital admission, the individual is at a greater risk of worsening health and, once discharged, is at risk of being readmitted back into hospital. Pulmonary rehabilitation is recommended by recent National Institute for Clinical Excellence guidelines at this stage, and should ideally be offered within 4 weeks of discharge from hospital. However, despite its proven benefits, pulmonary rehabilitation programmes can be unappealing to a large number of patients. There is, therefore, a need to develop alternative ways to support patients being discharged from hospital with COPD in order to manage their breathlessness, their stress levels and help them regain their physical and social abilities. We believe that the internet may provide the opportunity to increase the provision of accessible information to help patients better understand and self-manage their condition. We have developed a website in collaboration with both experts in pulmonary rehabilitation and patients. We want to offer a self-management programme to patients with COPD for a period of 3 months after discharge from hospital using tablet computers to help, guide, support and encourage them to better understand and manage their condition and thereby reduce unnecessary readmission to hospital.

Who can participate?
Patients admitted to hospital with a diagnosis of exacerbation (worsening) COPD.

What does the study involve?
Participants are given access to the self-management programme for a period of 3 months.
The tablet computers will be preloaded with the web-based version of the SPACE for COPD programme and are offered face-to-face video conferencing with clinicians/nurses. Normal care will not be disrupted including referral and attendance to pulmonary rehabilitation. We are interested to see if this intervention increases patient uptake of pulmonary rehabilitation services offered.

What are the possible benefits and risks of participating?
The research participant will have increased access to resources on line and the support and guidance through this web-based self-management programme for six months. In addition the research participant will be able to book an online appointment to speak to a specialist respiratory nurse about any worry or concerns they have about their lung condition and symptoms. This may in turn prevent an unnecessary admission to hospital. We believe this project will address directly the concerns express in the British Lung Foundation survey 'ready for home' . There would be no adverse effects in terms of pain, discomfort or inconvenience. All patients will receive usual care. The only potential adverse effect would be the patients having to remember to login onto the website to access the self-management programme with potentially issues around remembering password, and navigation. Such issues will be minimised by use specialist respiratory nurses to advise and support eligible patients, checking patients progress. We will encouraging patients to phone or video conference the respiratory discharge nurses for advice or help, this is routine proactive currently. We are keen to explore the aim of video conferencing facilities to be able to advise the individual on inhaler technique, breathing control or physical activity strategies more effectively than over the telephone. We have a specifically trained nurse with expertise is web based programme and who has helped design and implement a similar web based programme for cardiac patients. This nurse will be available to support the respiratory nurses and is part of the project team.

Where is the study run from?
University Hospitals of Leicester NHS Trust (UK)

When is the study starting and how long is it expected to run for?
September 2014 to May 2017

Who is funding the study?
Academic Health Science Networks (UK)

Who is the main contact?
Ms Sally Boyce
sally.boyce@uhl-tr.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Linzy Houchen-Wolloff

ORCID ID

Contact details

Centre for Exercise and Rehabilitation Science
Respiratory Biomedical Research Unit
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
+44 (0)116 250 2759
Linzy.Houchen@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol version 1

Study information

Scientific title

InterSPACE: feasibility of an integrated telehealth and self-management programme for individuals hospitalised with an exacerbation of COPD

Acronym

interSPACE

Study hypothesis

To assess the feasiblity and acceptability of an integrated telehealth self-management programme for individuals hospitalised with an exacerbation of their COPD

Ethics approval

NRES Committee East Midlands-Derby, 22/09/2014, ref: 14/EM/1105

Study design

Single-centre non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Internet

Trial type

Treatment

Patient information sheet

http://www.leicestershospitals.nhs.uk/aboutus/departments-services/pulmonary-rehabilitation/research-and-development/

Condition

Respiratory COPD exercabations

Intervention

Integrated online self management programme. Does not alter usual care.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The reason for this project is to understand the feasibility and acceptability of the novel tablet based self management support at the time of a hospital discharge. The primary consideration for the study will be uptake and acceptability. Uptake will be reported and we will closely monitor the web usage through a sophisticated web monitoring component embedded in the existing site.

Secondary outcome measures

Current secondary outcome measures as of 21/03/2016:
1. Readmission rates (hospital record checks)
2. Health-related quality of life (CAT and CRQ questionnaire)
3. Anxiety and depression (HADS questionnaire)
4. Physical activity (PACER questionnaire)
5. Impact on clinical team (staff time/cost)
6. Patient and clinician thoughts about the study and intervention (qualitative interviews)
Collected at 3 and 6 months.

Previous secondary outcome measures:
1. Health-related quality of life
2. Anxiety and depression
3. Hospital readmissions.
These will be collected at baseline and after 6 and 12 months.

Overall trial start date

22/09/2014

Overall trial end date

30/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patient population: Patients admitted with a primary diagnosis of exacerbation COPD. This may include patients with existing disease or patients who are newly diagnosed on admission to hospital. All patients who are admitted into the Glenfield Hospital with an exacerbation of or newly diagnosed COPD will be screened for eligibility i.e. willing to take part in this pilot study. We will assume that individuals do not necessarily need have Wi-Fi access and provide that 3G connection as part of the package. Eligible patients will however need to have a current email account and be computer literate. Willing participants will be given full instructions on how to access the SPACE self-management programme website via their chosen device.

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Unwilling to participate
2. Individuals with significant co-morbidities to limit physical activity
3. Unable to read or write English
4. Not computer literate

Recruitment start date

08/05/2015

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Respiratory Biomedical Research Unit
Centre for Exercise and rehabilitation Science
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Trust HQ
Level 3 Balmoral Building
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Academic Health Science Network East Midlands (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

As the primary aim of this study is to inform a definitive trial, we will disseminate the results of this study widely with appropriate stakeholders (commissioning groups, service managers and service users). This will take the form of steering groups meeting (held monthly), PPI feedback (local group held every 3 months) and abstract submission to national conferences.

Intention to publish date

30/08/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/10/2016: the following changes were made to the trial record: 1. The recruitment end date was changed from 30/11/2016 to 28/02/2017. 2. The overall trial end date was changed from 30/05/2017 to 30/08/2017. 31/08/2016: the following changes were made to the trial record: 1. The recruitment end date was changed from 30/07/2016 to 30/11/2016. 2. The overall trial end date was changed from 30/11/2016 to 30/05/2017. 21/03/2016: the following changes were made to the trial record: 1. The overall trial start date was changed from 01/01/2015 to 22/09/2014. 2. The overall trial end date was changed from 30/01/2016 to 30/11/2016.