Home telemonitoring for patients with chronic obstructive pulmonary disease (COPD)

ISRCTN	ISRCTN18443546
DOI	https://doi.org/10.1186/ISRCTN18443546
Secondary identifying numbers	N/A

Submission date: 16/11/2009
Registration date: 08/01/2010
Last edited: 17/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Keir Lewis
Scientific

Respiratory Centre
Prince Philip Hospital
Llanelli
SA14 8QF
United Kingdom

Phone	+44 (0)1554 783133
Email	k.e.lewis@swansea.ac.uk

Study information

Study design	Randomised controlled cross-over trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Does home telemonitoring reduce healthcare use in recurrent hospital attenders with chronic obstructive pulmonary disease (COPD)? A pilot randomised trial
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(s)	Dyfed Powys Local Research Ethics Committee pending approval approval pending as of 02/11/2009
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
Primary outcome measure	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 study start date	04/01/2010
Overall study end date	03/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	240 - 120 in each of the two arms of the study
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 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
Wales

Study participating centre

Prince Philip Hospital

Llanelli
SA14 8QF
United Kingdom

Sponsor information

Hywel Dda Health Board (UK)
Hospital/treatment centre

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

Website	http://www.hywelddalhb.wales.nhs.uk/
"ROR"	https://ror.org/012gye839

Funders

Funder type

Government

Welsh Assembly Government (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010	17/01/2019	Yes	No
Results article	results	01/02/2010	17/01/2019	Yes	No

Editorial Notes

17/01/2019: Publication references added.
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.