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 |
| Protocol serial number | N/A |
| Sponsor | University Hospital Aintree (UK) |
| Funder | South Sefton Primary Care Trust (in collaboration with Liverpool and Knowsley Primary Care Trusts) (UK) |
- 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
Scientific
Aintree Chest Centre
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
| Phone | +44 (0)151 529 3796 |
|---|---|
| lisa.davies@aintree.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Number of hospital admissions for COPD at 12 months |
| Key secondary outcome measure(s) |
1. Quality of life/health status |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/06/2016: No publications found, verifying study status with principal investigator.
