CClinicalTrials.gg
CompletedNCT00129779Updated Jun 8, 2015

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

An interventional study of Intermediate care package in COPD, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-06-08.

Sponsored by Imperial College London · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • COPD

Keywords

  • COPD
03

In context

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
122 participants

Interventions

  • BehavioralIntermediate care package
06

What researchers measure

Primary outcomes

  1. Number of hospital admissions for exacerbations of COPD

Secondary outcomes

  1. Number of unplanned visits to a general practitioner

  2. Measures of quality of life (SF-36; Canadian Respiratory Disease Questionnaire [CRDQ])

07

Study locations

1 site
  • Respiratory Medicine, NHLI at Charing Cross Hospital
    London, W6 8RF, United Kingdom
08

References and documents

Publications

  • The burden of lung disease. British Thoracic Society, London, 2001.
  • King's Fund report - 'Managing the pressure' by Michael Damiani and Jennifer Dixon. King's Fund, London 2002
  • 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. doi: 10.1016/s0140-6736(97)11048-0. PubMed 9652670 ↗
  • 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. doi: 10.1136/bmj.294.6566.225. PubMed 3101821 ↗
  • 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. doi: 10.1016/S0140-6736(96)04201-8. PubMed 8888163 ↗
  • British Thoracic Society Standards of Care Subcommittee on Pulmonary Rehabilitation. Pulmonary rehabilitation. Thorax. 2001 Nov;56(11):827-34. doi: 10.1136/thorax.56.11.827. No abstract available. PubMed 11641505 ↗
  • Parrott S, Godfrey C, Raw M, West R, McNeill A. Guidance for commissioners on the cost effectiveness of smoking cessation interventions. Thorax. 1998 Dec;53 Suppl 5 Pt 2(Suppl 5):S1-38. No abstract available. PubMed 10226676 ↗
  • Raw M, McNeill A, Watt J, Raw D. National smoking cessation services at risk. BMJ. 2001 Nov 17;323(7322):1140-1. doi: 10.1136/bmj.323.7322.1140. No abstract available. PubMed 11711385 ↗
  • 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. doi: 10.1053/rmed.1999.0749. PubMed 10783940 ↗
  • 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(Suppl 5):S1-28. No abstract available. PubMed 9474238 ↗
  • 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. doi: 10.1164/ajrccm.163.5.2101039. No abstract available. PubMed 11316667 ↗
  • Sridhar M, Taylor R, Dawson S, Roberts NJ, Partridge MR. A nurse led intermediate care package in patients who have been hospitalised with an acute exacerbation of chronic obstructive pulmonary disease. Thorax. 2008 Mar;63(3):194-200. doi: 10.1136/thx.2007.077578. Epub 2007 Sep 27. PubMed 17901162 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00129779
Lead sponsor
Imperial College London
Collaborators
The Health Foundation
First posted
Aug 12, 2005
Start date
Dec 2003
Completion
Aug 2006
Last update
Jun 8, 2015

Study contacts

Martyn R Partridge, MD FRCP
principal investigator · Imperial College London
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion