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Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients With COPD

This study has been completed.
Sponsor:
Collaborator:
The Health Foundation
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00129779
First received: August 11, 2005
Last updated: May 8, 2008
Last verified: May 2008

August 11, 2005
May 8, 2008
December 2003
Not Provided
Number of hospital admissions for exacerbations of COPD
Same as current
Complete list of historical versions of study NCT00129779 on ClinicalTrials.gov Archive Site
  • Number of unplanned visits to a general practitioner
  • Measures of quality of life (SF-36; Canadian Respiratory Disease Questionnaire [CRDQ])
number of unplanned visits to a general practitioner measures of quality of life (SF-36; CRDQ)
Not Provided
Not Provided
 
Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients With COPD
A Randomised Control Trial Assessing the Effects of an Intermediate Care Package in Preventing Hospitalisation of Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a term used for the conditions of chronic bronchitis and emphysema, diseases that are very common among the elderly and diseases that account for up to15% of all general medical admissions to National Health Service Hospitals. In a recent report on emergency admissions to acute hospitals in London, the King's Fund concluded that taking better care of elderly patients with COPD could reduce pressures on acute hospitals, and suggested that identification of vulnerable patients with lung disease and "pro-active," rather than "reactive," management might reduce the chances of hospitalisation. In this study, the investigators wish to compare a group of patients with COPD who are managed in the normal way, with another group of patients with COPD who receive all interventions known to be of some benefit to those with this condition. This will include a pulmonary rehabilitation programme, intensive education regarding self care, targeted advice to their general practitioners regarding how best to manage COPD, and regular contact with specialist respiratory nurses who will support the patients in their own homes by a combination of home visits and telephone contact. The value of such a comprehensive intervention will be studied, in terms of both its ability to reduce admissions to the hospital and its impact on quality of life.

One hundred twenty-two patients over the age of 50 with COPD, admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of their condition will be recruited and randomised to routine and opportunistic care (n= 61) vs study care package (n=61) for 2 years. The patients randomised to the study package will take part in an initial pulmonary rehabilitation programme of 8 sessions of physical therapy and education (2 sessions a week for 4 weeks). Health related quality of life will be measured in the intervention and routine care groups using validated instruments (SF-36 and Canadian Respiratory Diseases Questionnaire). This will be followed by a baseline home visit and assessment from an experienced specialist respiratory nurse (Grade G), followed by monthly telephone calls and a home visit every 3 months. Each interview and visit will be a structured intervention addressing specific issues related to the management of COPD, with four possible specific outcomes including history taking; measurement of vital signs; discussion of treatment; appropriate vaccination and discussing and reinforcing self-management education. At the end of the 2 year study period the routine care and intervention groups will be compared for the following outcomes: number of admissions to hospital for exacerbations of COPD; number of unplanned visits to a general practitioner (with those initiated by study nurse identified separately); measures of quality of life (SF-36; CRDQ).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
COPD
Behavioral: Intermediate care package
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
August 2006
Not Provided

Inclusion Criteria:

  • Patients over the age of 50 with COPD
  • Admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of COPD

Exclusion Criteria:

  • Significant co-morbidity including severe heart disease and cancer
  • Any condition that would preclude participation in the physical therapy component of a pulmonary rehabilitation programme, including musculoskeletal diseases
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00129779
NHLICX3038
Not Provided
Not Provided
Imperial College London
The Health Foundation
Principal Investigator: Martyn R Partridge, MD FRCP Imperial College London
Imperial College London
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP