Tele-Health for Early Stage Chronic Obstructive Pulmonary Disease: a pilot study

ISRCTN	ISRCTN68856013
DOI	https://doi.org/10.1186/ISRCTN68856013
Secondary identifying numbers	N/A

Submission date: 22/09/2010
Registration date: 05/11/2010
Last edited: 24/03/2017

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 of protocol

Not provided at time of registration

Contact information

Prof Gail Mountain
Scientific

Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Email	g.a.mountain@sheffield.ac.uk

Study information

Study design	Pilot single-centre single-blind two-arm randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Pilot study in preparation for a pragmatic randomised controlled trial of tele-health for early stage chronic obstructive pulmonary disease
Study objectives	1. Tele-health monitoring will reduce the proportion of patients who require hospital admission to manage their Chronic Obstructive Pulmonary Disease (COPD) for the duration of, and for six months following discharge from the Tele-health-supported Community COPD Service when compared with those who received the standard Community COPD Service 2. Tele-health monitoring will improve the quality of life for patients for the duration of, and for six months following discharge from the standard Community COPD Service as measured by a change from baseline in the St Georges Respiratory Questionnaire compared to the usual care group.
Ethics approval(s)	Approval received from the South Yorkshire Research Ethics Committee on the 29th of 2010, ref: 10/H1310/48
Health condition(s) or problem(s) studied	Chronic Obstructive Pulmonary Disease (COPD)
Intervention	Patients will be randomised to one two groups: 1. Telehealth supported COPD Service: 1.1. Three home visits with COPD specialist clinicians (nurse or physiotherapist) 1.1.1. within 24 hours of hospital discharge 1.1.2. within 48 hours of hospital discharge 1.1.3. week 8 after hospital discharge 1.2. Daily use of telemonitoring equipment by patient for eight weeks post hospital discharge 2. Standard COPD Service: 2.1. Five home visits and one telephone consultation with COPD specialist clinicians (nurse or physiotherapist) 2.1.1. within 24 hours of hospital discharge 2.1.2. within 48 hours of hospital discharge 2.1.3. 4 days after hospital discharge 2.1.4. 14 days after hospital discharge 2.1.5. 6 weeks after hospital discharge (telephone consultation) 2.1.6. week 8 after hospital discharge
Intervention type	Other
Primary outcome measure	1. The health service primary outcome will be the proportion of patients who are admitted to hospital with COPD as their primary or secondary cause of admission either during or six months following discharge from the Tele-health supported or standard Community COPD Service. This will be assessed through analysis of patient-completed self-reporting diaries and hospital either during or six months following the Tele-health supported or standard Community COPD Service and analysis of hospital admission/visit data 2. The patient-centred primary outcome will be the patients St. Georges Respiratory Questionnaire score upon admission to either the Tele-health supported or standard Community COPD Service, eight weeks later on discharge and six months later. This scale is a validated and widely-used instrument which measures health impairment in patients with COPD on a scale of 0 to 100 (greatest impairment). This scale is responsive to change with a minimum important difference (MID) of 4
Secondary outcome measures	1. Proportion of patients requiring unscheduled health care support to manage their COPD (including A&E, GP or community nurse visits) either during or six months following the standard Community COPD Service to be collected through patient-completed self-reporting diaries for the standard service and using the technology for the Tele-health supported service; and analysis of hospital, GP and community nursing visit data 2. Cost effectiveness of intervention 3. Improved self-management of their COPD by the patient to be assessed through analysis of the St. Georges Respiratory Questionnaire and a self-completed bespoke patient satisfaction questionnaire 4. Satisfaction with technology as part of their Tele-health supported Community COPD Service to be assessed through analysis of a self-completed bespoke patient satisfaction questionnaire
Overall study start date	01/11/2010
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Open to male and female adult participants (> age 16) 2. Being discharged from the local NHS Foundation Trust and diagnosed with COPD 3. Between 1 and 3 previous admissions (including the current admission) in the previous 12 months according to the hospital discharge abstract from the current date of discharge where COPD is the primary or secondary documented reason for hospitalisation 4. Patient opts to be included in the caseload of the Community COPD Service 5. Willing to use Tele-health technology as part of their discharge plan 6. Able to communicate in English and read English (a requirement of the technology) 7. Have a telephone landline and a viable telecommunications network with no more than three internal telephone extensions
Key exclusion criteria	1. Prior/current involvement in another tele-health initiative 2. Cognitive impairment to the extent that it impedes ability to participate 3. Other significant impairments which will restrict ability to participate 4. No telephone landline 5. Unwilling to use Tele-health technology 6. Existence of co-morbidities which require on-going intervention from other community nursing services 7. More than three hospital admissions within twelve months of the date of discharge for which COPD is the primary diagnosis 8. Patient unable or unwilling to provide written or oral informed consent
Date of first enrolment	01/11/2010
Date of final enrolment	31/01/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Regent Court

Sheffield
S1 4DA
United Kingdom

Sponsor information

Barnsley Health and Social Care Research Alliance (UK)
Hospital/treatment centre

Gawber Road
Barnsley
S75 2EP
England
United Kingdom

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care, South Yorkshire (CLAHRC SY)

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	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/01/2011	Yes	No
Results article	results	06/08/2014	Yes	No
Results article	results	22/03/2017	Yes	No

Editorial Notes

24/03/2017: Publication reference added.