Condition category
Respiratory
Date applied
13/09/2005
Date assigned
27/09/2006
Last edited
14/06/2016
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 Lisa Davies

ORCID ID

Contact details

Aintree Chest Centre
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 3796
lisa.davies@aintree.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

EXHALE (Exercise, Home support and Lung Education)

Study hypothesis

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

Sefton Research and Ethics Committee, September 2004. Ref: 04/Q1501/75

Study design

Randomised controlled 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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2004

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

270

Participant 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

Recruitment start date

01/10/2004

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Aintree
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

University Hospital Aintree (UK)

Sponsor details

Lower Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 3796
lisa.davies@aintree.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

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