Condition category
Respiratory
Date applied
14/11/2008
Date assigned
23/12/2008
Last edited
07/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Keir Lewis

ORCID ID

Contact details

Respiratory Unit
Prince Phillip Hospital
Hwyel Dda NHS Trust
Llanelli
SA15 3LQ
United Kingdom
+44 (0)1554 783133
keir_lewis@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07/WMW01/53

Study information

Scientific title

Acronym

Better Breathing

Study hypothesis

Are home electronic monitoring and electronic learning resources feasible and safe for patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Ethics approval

Carmarthenshire LREC gave approval on the 29th October 2007

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Patients will be randomised into two groups, to either receive standard care or to receive six months telehealth support (doc@HOME), which is an integrated solution for the remote health management of patients with long term conditions and consists of a robust, handheld data collection unit which connects through a standard telephone line at the patient's home to a secure server. doc@HOME is designed to ensure that care follows the patient providing access from anywhere at anytime. Patients will be able to:
1. Complete a system integrated patient tailored questionnaire regarding respiratory status and upload daily
2. Automated daily uploading of physiological measurements obtained from a pulse oximeter and digital thermometer
3. Receive feedback through the system in the form of text/email-like messages between the patient and clinician in response to uploads that can either be automated or targeted according to the review of information received

All patients will be required to fill in a series of questionnaires (St George's Respiratory Questionnaire, the Hospital Anxiey and Depression Score questionnaire and the ED-5Q questionnaire) to assess health status and quality of life at five timepoints: baseline, 1 month, 6 months, 7 months and 12 months. Together, these take about 30 minutes to complete. These will be delivered in face-to-face interviews by a member of the Chronic Disease Management Team.

The first six months of the study will be the active intervention in which half of the sample will receive the telehealth support, after which there will be six months of passive intervention in order to assess changes in general health status and quality of life.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Are home electronic monitoring and electronic learning resources feasible and safe for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)? Measured at baseline, 1 month and 6 months only.

Secondary outcome measures

1. Does home telemedicine reduce respiratory hospital admissions?
2. Does home telemedicine reduce community specialist team visits?
3. Does home telemedicine improve quality of life and mood?
4. Is home telemedicine cost-effective?

Measured at all timepoints throughout the trial.

Overall trial start date

01/11/2007

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Participants (no gender/age specification) will be recruited for the study from the Prince Phillip and West Wales General Hospital Pulmonary Rehabilitation Scheme. The standard inclusion criteria to be accepted through the scheme for pulmonary rehabilitation is patients who:
1. Feel limited by their chest
2. Have a primary physician
3. Spirometric diagnosis of COPD
4. Are on maximal respiratory medications
5. Have no unstable cardiac disease
6. Have no cognitive impairments

In addition, for this project, participants must:
7. Be willing and able to provide informed consent
8. Have a standard telephone line installed in their homes
9. Be willing to have equipment installed in their homes
10. Have attended at least 50% of pulmonary rehabilitation (PR) sessions (aiming for equal baselines)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. No other confounding medical condition to the use of the equipment, e.g. unable to see clearly or touch the screen
2. Not in a nursing or residential institution
3. Participation in any investigational drug trial within one month prior to recruitment
4. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study

Recruitment start date

01/11/2007

Recruitment end date

01/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Unit
Llanelli
SA15 3LQ
United Kingdom

Sponsor information

Organisation

Informing Healthcare (UK)

Sponsor details

c/o Dr Daniel Warm
10/11 Oldfield Road
Bocam Park
Pencoed
CF35 5LJ
United Kingdom
+44 (0)1656 678121
daniel.warm@wales.nhs.uk

Sponsor type

Government

Website

http://www.wales.nhs.uk/ihc

Funders

Funder type

Government

Funder name

European Community eTEN programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20214462

Publication citations

  1. Results

    Lewis KE, Annandale JA, Warm DL, Rees SE, Hurlin C, Blyth H, Syed Y, Lewis L, Does home telemonitoring after pulmonary rehabilitation reduce healthcare use in optimized COPD? A pilot randomized trial., COPD, 2010, 7, 1, 44-50, doi: 10.3109/15412550903499555.

Additional files

Editorial Notes