Condition category
Respiratory
Date applied
16/11/2009
Date assigned
08/01/2010
Last edited
04/08/2014
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 Keir Lewis

ORCID ID

Contact details

Respiratory Centre
Prince Philip Hospital
Llanelli
SA14 8QF
United Kingdom
+44 (0)1554 783133
k.e.lewis@swansea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does home telemonitoring reduce healthcare use in recurrent hospital attenders with chronic obstructive pulmonary disease (COPD)? A pilot randomised trial

Acronym

Study hypothesis

To see if telemonitor deployment results in fewer admissions to hospital for chronic obstructive pulmonary disease (COPD).

Secondary outcomes:
1. To test the null hypotheses that there is no difference in primary care contacts, emergency room attendances, length of hospital admissions, Chronic Disease Management Team (CDMT) phone calls/visits, quality of life (computerised adaptive testing [CAT], EuroQol instrument [EQ5D]) scores during the 12 months 'telemedicine plus standard care' versus 12 months 'standard care alone'.
2. To record telemedicine usage/concordance during the 12-month monitoring period
3. To estimate cost-effectiveness of telemedicine using changes in EQ5D, CAT scores and healthcare contacts

Ethics approval

Dyfed Powys Local Research Ethics Committee pending approval – approval pending as of 02/11/2009

Study design

Randomised controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

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

From hospital databases, we will identify 240 patients who have had more than two admissions to any of Prince Philip, West Wales General, Withybush and Bronglais Hospitals within the last 2 years.

Medications will be optimised if not already done. 120 will be randomised to receive telemonitors (Tm's) for 1 year whilst the other 120 receive standard care. After 1 year, the Tm's will be swapped into the homes of the second group (120) in a crossover trial for a further year of monitoring.

Once daily the patients would complete a set of questions relating to COPD symptoms and record their oxygen levels, pulse rate and temperature. The Tm automatically sends the information via a (free) telephone line to a secure internet site. The results are reviewed daily by the home COPD specialist team and if there is any signs of worsening of their condition they would intervene with a phone call followed by a visit and treatment escalation, if appropriate. We hope that earlier intervention may prevent further deterioration, requiring hospital admission or multiple GP visits. The monitors are also set up to generate an email alert to the nurses if any questions or recordings indicate a significant deterioration. All participants are aware that the Tm is not a replacement for their usual actions but to be used as an early warning system and they should seek direct help live in a severe emergency.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The number of hospital admissions

Secondary outcome measures

1. Quality of life measures (EQ-5D and CA-COPD questionnaires) at baseline and every 6 months for 2 years
2. Healthcare contacts - GP visits, outpatient visits and home contacts by the community COPD nurses over the 2 years of the study
3. A cost evaluation will also be undertaken after the 2 years

Overall trial start date

04/01/2010

Overall trial end date

03/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 240 still living subjects with a primary diagnosis of COPD will identified from hospital admissions database
2. Two or more admissions to any of the following hospitals in the last 2 years - Prince Philip; West Wales General; Withybush; Bronglais
3. Diagnosis and reason for admission corroborated by a member of the research team
4. We will include COPD of any severity of airflow obstruction, who have been admitted to hospital two or more times in the last 2 years
5. Participants must be at least 40 years old, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240 - 120 in each of the two arms of the study

Participant exclusion criteria

1. Inability or refusal to sign informed consent
2. Less than 40 years of age
3. Life expectancy less than 2 years or cognitive/physical impairment that would preclude home telemonitoring use

Recruitment start date

04/01/2010

Recruitment end date

03/01/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Centre
Llanelli
SA14 8QF
United Kingdom

Sponsor information

Organisation

Hywel Dda Health Board (UK)

Sponsor details

c/o Mr Chris Tattersall
Withybush Hospital
Fishguard Road
Haverfordwest
SA61 2PZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Government

Funder name

Welsh Assembly Government (UK)

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

Publication citations

Additional files

Editorial Notes