A randomised prospective controlled study to assess the effects of a respiratory case management model on hospital readmission rates in patients with moderate to severe chronic obstructive pulmonary disease

ISRCTN	ISRCTN33946398
DOI	https://doi.org/10.1186/ISRCTN33946398
Secondary identifying numbers	N/A

Submission date: 13/09/2005
Registration date: 27/09/2006
Last edited: 14/06/2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lisa Davies
Scientific

Aintree Chest Centre
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom

Phone	+44 (0)151 529 3796
Email	lisa.davies@aintree.nhs.uk

Study information

Study design	Randomised controlled 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	A randomised prospective controlled study to assess the effects of a respiratory case management model on hospital readmission rates in patients with moderate to severe chronic obstructive pulmonary disease
Study acronym	EXHALE (Exercise, Home support and Lung Education)
Study objectives	Whether intensive education, support and individualised exercise programme can reduce hospital admissions in patients with moderate to severe Chronic Obstructive Pumonary Disease (COPD).
Ethics approval(s)	Sefton Research and Ethics Committee, September 2004. Ref: 04/Q1501/75
Health condition(s) or problem(s) studied	Chronic Obstructive Pulmonary Disease
Intervention	Case management model of care: weekly home visits and small group exercise sessions for eight weeks. Monthly visits thereafter, with weekly, then fortnightly phone calls. Dedicated telephone support seven days a week for 12 months. Control group have usual care.
Intervention type	Other
Primary outcome measure	Number of hospital admissions for COPD at 12 months
Secondary outcome measures	1. Quality of life/health status 2. Exercise capacity, lung function, and treatment over a one year period 3. Total number and length of hospital admissions for any cause 4. Number of General Practitioner visits, accident and emergency department visits over the 12 month follow up
Overall study start date	01/10/2004
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	270
Key inclusion criteria	1. Patients with moderate to severe COPD confirmed on spirometry 2. Aged 40 years or more who have had one or more admission to hospital in last 12 months 3. Must be current or ex-smokers 4. Must have home telephone
Key exclusion criteria	1. Patients with previous diagnosis of asthma 2. Significant/unstable cardiac dysfunction 3. Underlying malignancy, dementia or major psychiatric illness 4. Participation in pulmonary rehabillitation in last 12 months
Date of first enrolment	01/10/2004
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospital Aintree

Liverpool
L9 7AL
United Kingdom

Sponsor information

University Hospital Aintree (UK)
Hospital/treatment centre

Lower Lane
Liverpool
L9 7AL
England
United Kingdom

Phone	+44 (0)151 529 3796
Email	lisa.davies@aintree.nhs.uk
"ROR"	https://ror.org/008j59125

Funders

Funder type

Government

South Sefton Primary Care Trust (in collaboration with Liverpool and Knowsley Primary Care Trusts) (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

Editorial Notes

14/06/2016: No publications found, verifying study status with principal investigator.