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
  Purpose

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.


Condition Intervention
COPD
Behavioral: Intermediate care package

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Randomised Control Trial Assessing the Effects of an Intermediate Care Package in Preventing Hospitalisation of Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Number of hospital admissions for exacerbations of COPD

Secondary Outcome Measures:
  • Number of unplanned visits to a general practitioner
  • Measures of quality of life (SF-36; Canadian Respiratory Disease Questionnaire [CRDQ])

Estimated Enrollment: 122
Study Start Date: December 2003
Estimated Study Completion Date: August 2006
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129779

Locations
United Kingdom
Respiratory Medicine, NHLI at Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
The Health Foundation
Investigators
Principal Investigator: Martyn R Partridge, MD FRCP Imperial College London
  More Information

Publications:
King's Fund report - 'Managing the pressure' by Michael Damiani and Jennifer Dixon. King's Fund, London 2002

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00129779     History of Changes
Other Study ID Numbers: NHLICX3038
Study First Received: August 11, 2005
Last Updated: May 8, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
COPD

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014