|
ISRCTN
|
ISRCTN18443546
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Home telemonitoring for patients with chronic obstructive pulmonary disease (COPD)
|
|
Scientific title
|
Does home telemonitoring reduce healthcare use in recurrent hospital attenders with chronic obstructive pulmonary disease (COPD)? A pilot randomised trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
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 health care contacts
|
|
Lay summary
|
|
|
Ethics approval
|
Dyfed Powys Local Research Ethics Committee pending approval as of 2nd November 2009
|
|
Study design
|
Randomised controlled cross-over trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Chronic obstructive pulmonary disease (COPD)
|
|
Participants - 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 two 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
|
|
Participants - 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
4. Physical impairment that would preclude home telemonitoring use
|
|
Anticipated start date
|
04/01/2010
|
|
Anticipated end date
|
03/01/2012
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet.
|
|
Target number of participants
|
240 - 120 in each of the two arms of the study
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
The number of hospital admissions
|
|
Secondary outcome measure(s)
|
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, out patient 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
|
|
Sources of funding
|
Welsh Assembly Government (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Keir
Lewis
|
|
Address
|
Respiratory Centre
Prince Philip Hospital
|
|
City/town
|
Llanelli
|
|
Zip/Postcode
|
SA14 8QF
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1554 783133
|
|
Email
|
k.e.lewis@swansea.ac.uk
|
|
Sponsor
|
Hywel Dda Health Board (UK)
|
|
Address
|
c/o Mr Chris Tattersall
Withybush Hospital
Fishguard Road
|
|
City/town
|
Haverfordwest
|
|
Zip/Postcode
|
SA61 2PZ
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.hywelddalhb.wales.nhs.uk/
|
|
Date applied
|
16/11/2009
|
|
Last edited
|
08/01/2010
|
|
Date ISRCTN assigned
|
08/01/2010
|
