A study of the impact of a written action plan and multi-disciplinary (respiratory specialist nurse led) intervention in preventing re-admission and improving quality of life through better disease management in patients admitted with an exacerbation

ISRCTN ISRCTN70191324
DOI https://doi.org/10.1186/ISRCTN70191324
Secondary identifying numbers N0107162719
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
21/09/2012
Recruitment status
Stopped
Overall study status
Stopped
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 Indranil Chakravorty
Scientific

Department of Respiratory Medicine
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Phone +44 01438 314333 ext. 5869
Email indranil.chakravorty@nhs.net

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory: Asthma
InterventionA randomised, controlled trial of a self-management protocol 'Action Plan' against conventional treatment, I patients who are admitted with an acute exacerbation of a COPD or a fter a visit to the OP clinic (with a history of admission within the last 6 months). All patients would undergo baseline spirometry with assessment of reversibility to salbutamol in order to diagnose COPD and exclude asthma.

Patients randomised to the intervention group would receive:
1. Education about the nature of disease, risk factors, progression, pathophysiology of exacerbations and basic principles of management
2. Smoking cession
3. Nutritional assessment
4. Physiotherapy advice on the potential for exercise and pulmonary rehabilitating
5. Respiratory assessment

21/09/2012: Please note that this trial was stopped due to a lack of funding.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Salbutamol
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2005
Completion date01/03/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2005
Date of final enrolment01/03/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Respiratory Medicine
Stevenage
SG1 4AB
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Hertfordshire Hospitals Research and Development Consortium (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan