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Clinical Trial: Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients with COPD

This study is no longer recruiting patients.

Sponsors and Collaborators:	Imperial College London The Health Foundation
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00129779

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, we 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 hospital and its impact on quality of life

Condition	Intervention
COPD	Behavior: Intermediate care package

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment

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)

Further Study Details:

Primary Outcomes: Number of hospital admissions for exacerbations of COPD
Secondary Outcomes: number of unplanned visits to a general practitioner measures of quality of life (SF-36; CRDQ)
Expected Total Enrollment: 122

Study start: December 2003; Study completion: September 2006
Last follow-up: August 2006; Data entry closure: August 2006

122 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 - 90 Years, Genders Eligible for Study: Both

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 musculo-skeletal diseases -

Location Information

United Kingdom
Respiratory Medicine, NHLI at Charing Cross Hospital, London, W6 8RF, United Kingdom

Study chairs or principal investigators

Martyn R Partridge, MD FRCP, Principal Investigator, Imperial College

More Information

Publications

Gravil JH, Al-Rawas OA, Cotton MM, Flanigan U, Irwin A, Stevenson RD. Home treatment of exacerbations of chronic obstructive pulmonary disease by an acute respiratory assessment service. Lancet. 1998 Jun 20;351(9119):1853-5.

Cockcroft A, Bagnall P, Heslop A, Andersson N, Heaton R, Batstone J, Allen J, Spencer P, Guz A. Controlled trial of respiratory health worker visiting patients with chronic respiratory disability. Br Med J (Clin Res Ed). 1987 Jan 24;294(6566):225-8.

Lacasse Y, Wong E, Guyatt GH, King D, Cook DJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. Lancet. 1996 Oct 26;348(9035):1115-9.

British Thoracic Society Standards of Care Subcommittee on Pulmonary Rehabilitation. Pulmonary rehabilitation. Thorax. 2001 Nov;56(11):827-34. Review. No abstract available.

Raw M, McNeill A, Watt J, Raw D. National smoking cessation services at risk. BMJ. 2001 Nov 17;323(7322):1140-1. No abstract available.

Gallefoss F, Bakke PS. Impact of patient education and self-management on morbidity in asthmatics and patients with chronic obstructive pulmonary disease. Respir Med. 2000 Mar;94(3):279-87.

[No authors listed] BTS guidelines for the management of chronic obstructive pulmonary disease. The COPD Guidelines Group of the Standards of Care Committee of the BTS. Thorax. 1997 Dec;52 Suppl 5:S1-28. No abstract available.

Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76. Review. No abstract available.

Study ID Numbers: NHLICX3038
Last Updated: August 11, 2005
Record first received: August 11, 2005
ClinicalTrials.gov Identifier: NCT00129779
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-23

Source: ClinicalTrials.gov
Cache Date: August 24, 2005

Resources

Day Care (National Women's Health Information Center)
Day Care: Choosing a Good Center (American Academy of Family Physicians)

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Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients with COPD - Article

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Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients with COPD - Article

General Topics A-Z

Day Care

Deafness

Clinical Trial: Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients with COPD

Jump to Section

Purpose

Eligibility

Location Information

More Information

Resources

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