Condition category
Respiratory
Date applied
07/12/2008
Date assigned
30/01/2009
Last edited
28/07/2014
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 Hilary Pinnock

ORCID ID

Contact details

Centre for Population Health Sciences: GP Section
University of Edinburgh
20 West Richmond Street
Edinburgh
EH8 9DX
United Kingdom
+44 (0)131 650 8102
hilary.pinnock@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ARPG/07/3

Study information

Scientific title

Chronic obstructive pulmonary disease (COPD): The impact of a telemetric COPD monitoring service - a randomised controlled trial with nested qualitative study

Acronym

TELESCOT (TELEmetric supported Self-monitoring of long-term COndiTions) - COPD

Study hypothesis

Aims:
To investigate the clinical effectiveness, and social and service impact of introducing telemetry-aided, supervised, self-monitoring for chronic obstructive pulmonary disease (COPD) in primary care.

Research Questions: Randomised Controlled Trial
In people with moderate to severe COPD, does tele-supported self-monitoring compared to usual care:
1. Reduce the time to re-admission, and the number and length of hospital admissions and exacerbations?
2. Improve disease-specific quality of life
3. Reduce anxiety and depression?
4. Improve patient knowledge and self-efficacy?
5. Engage patients in self-care and improve compliance?
6. Represent a cost-effective use of NHS resources?

Qualitative Study:
1. What are the experiences of people with COPD and opinions of this service including impact on behaviour, mood, positive and negative experiences and change in relationship with their healthcare provider?
2. What are healthcare providers' experiences and opinions of this service?

Ethics approval

Lothian Research Ethics Committee, approved on 18/11/2008 (ref: 08/S1101/60)

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

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

Intervention

This is a one year researcher-blinded randomised controlled trial.

Intervention group
Patients in the intervention group will be given a modified "tablet" touch screen computer with video capability which is linked by broadband to a secure N3 connection to the internet. Shortly after the tele-monitoring equipment has been installed in their homes, patients allocated to the intervention group will be visited at home by the clinical team responsible for care to instruct them in its use. They will be given a written management plan and an emergency supply of antibiotics and steroids will be requested from the patients' own GP.

Daily (normally mornings) the patient will use the telemonitoring system to record symptoms and use of medication using a touch screen questionnaire and monitor peak flow and oxygen saturation using linked validated instruments. This information will be sent by the secure internet connection to an NHS server which is accessible via a high level password to the specialist respiratory clinicians involved in the care of the patients. The specialist respiratory team will routinely survey the on-line data every day and remind patients if they have not sent information or contact them if questionnaire responses and physiological parameters fall outside the expected range. Following discussion with the patient and repeat of physiological measurements (if required) appropriate clinical management will be instituted.

Control group:
Patients allocated to the control group will receive the same written management plan and will be instructed in its use. An emergency supply of antibiotics and steroids will be arranged with the patients' own GP. Specialist respiratory nurses/physiotherapists will provide comparable care for the control patients as for the intervention group, accessed though via the standard routes of communication, the only difference being that control group patients will not use the tele-monitoring system.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The time until first hospital admission with a primary diagnosis of an exacerbation of COPD up to one year post-randomisation.

An exacerbation is a sustained worsening of the patient's symptoms from his or her usual stable state that is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication.

An exacerbation is defined as being the 'primary diagnosis' if the presenting symptoms are consistent with, and the patient is treated for an acute exacerbation of COPD, and if no other disease was treated as a priority.

Secondary outcome measures

1. Exacerbations and admissions
1.1. The time until first hospital admission with a primary diagnosis of an exacerbation of COPD or all-cause deaths up to one year post-randomisation
1.2. The difference in mean number of bed-days for emergency admissions with a primary diagnosis of COPD during one calendar year
1.3. The number of hospital admissions with a primary diagnosis of COPD during one calendar year
1.4. The number and duration of admissions in which COPD is listed in the discharge letter as a factor in the admission (i.e., not necessarily the primary diagnosis) during one calendar year
1.5. The number of exacerbations (defined as a sustained worsening of the patient's symptoms necessitating a change in medication) during one calendar year
1.6. Proportion of deaths at one year. Cause of death will be taken from the primary and/or secondary care clinical records.

2. Quality of life
2.1. St George's Respiratory Questionnaire (SGRQ) at one year. The SGRQ is a validated and widely used instrument which measures health impairment (symptoms, activities and impacts) in patients with COPD on a scale: 100 (greatest impairment) to 0, is responsive to change, with a minimum important difference (MID) of 4.
2.2. Proportion of patients with an improvement of 4 or more units in the SGRQ at one year.

3. Anxiety and depression
3.1. Hospital Anxiety and Depression Scale (HADS) at one year. The HADS is a validated questionnaire with independent scales for anxiety and for depression (scores >=11 indicate significant anxiety [or depression]; scores <=7 are normal)

4. Patient knowledge and self-efficacy
4.1. Self-Efficacy for Managing Chronic Disease 6-item scale (SECD6) at one year. The SECD6 assesses confidence in ability to self-manage symptoms and impact on life on a scale of 1 (low self-efficacy) to 10 (high). It has been used in a range of long-term conditions.
4.2. Lung Information Needs Questionnaire (LINQ) at one year. The LINQ measures the information needs of people with COPD on a scale of 0 (low needs) to 25 (high). Scores correlate with the healthcare services accessed.

5. Engagement with process
5.1. Medication Adherence Report Scale (MARS) at one year. MARS-5 is a 5-item reduction of the validated MARS scale which has good reliability and validity in populations with respiratory conditions, and other chronic diseases. It assesses adherence to medication on a 5-point scale: higher scores indicating higher levels of adherence.
5.2. Compliance with monitoring and self-management will be assessed using the electronic record of symptoms and the action taken (or not) during one calendar year

6. Cost-effectiveness
6.1. Cost per Quality Adjusted Life-Years (QALYs) at one year. QALYs are derived from responses to the Euroqol EQ-5D.
6.2. Use of healthcare resources during one calendar year will be extracted from the patients' primary and secondary care records."

Overall trial start date

01/01/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, no age limits
2. Patients registered with Lothian general practices admitted with an exacerbation of COPD as the primary diagnosis to one of the three acute hospitals in Lothian in the previous year

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Patients with other significant lung disease
2. Unable to consent
3. Unable to use the technology (e.g., inability to use the technology or complete the questionnaires)
4. Other more significant medical/social reasons at the GPs discretion

Recruitment start date

01/01/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Population Health Sciences: GP Section
Edinburgh
EH8 9DX
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

c/o Dr Elspeth Currie
Edinburgh Clinical Trials Unit
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9446
ECTU@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk

Funders

Funder type

Government

Funder name

Chief Scientist Office, NHS Applied Research Programme Grant (UK) (ref: ARPG/07/3)

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

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19588056
2012 results in: http://thorax.bmj.com/content/67/Suppl_2/A27.1.abstract
2012 results in: http://erj.ersjournals.com/content/40/Suppl_56/P2726.abstract
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24136634

Publication citations

  1. Results

    Pinnock H, Hanley J, Lewis S, MacNee W, Pagliari C, van der Pol M, Sheikh A, McKinstry B, , The impact of a telemetric chronic obstructive pulmonary disease monitoring service: randomised controlled trial with economic evaluation and nested qualitative study., Prim Care Respir J, 2009, 18, 3, 233-235, doi: 10.4104/pcrj.2009.00040.

  2. Results

    Pinnock H, Hanley J, McCloughan L, Todd A, Krishan A, Lewis S, Stoddart A, van der Pol M, MacNee W, Sheikh A, Pagliari C, McKinstry B, Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial., BMJ, 2013, 347, f6070.

Additional files

Editorial Notes