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
Protocol serial number N0107162719
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders Hertfordshire Hospitals Research and Development Consortium (UK), NHS R&D Support Funding
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
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
PhaseNot Specified
Drug / device / biological / vaccine name(s)Salbutamol
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/03/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
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

  • United Kingdom
  • England

Study participating centre

Department of Respiratory Medicine
Stevenage
SG1 4AB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan