- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00129779
Assessment of the Effects of an Intermediate Care Package in Preventing Hospitalisation of Patients With COPD
4 juni 2015 uppdaterad av: Imperial College London
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.
Studieöversikt
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning
122
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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London, Storbritannien, W6 8RF
- Respiratory Medicine, NHLI at Charing Cross Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Number of hospital admissions for exacerbations of COPD
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Sekundära resultatmått
Resultatmått |
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Number of unplanned visits to a general practitioner
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Measures of quality of life (SF-36; Canadian Respiratory Disease Questionnaire [CRDQ])
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Martyn R Partridge, MD FRCP, Imperial College London
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- Smoking Cessation Guidelines and their Cost Effectiveness. Thorax 1998; 53: suppl 5
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2003
Primärt slutförande
7 december 2022
Avslutad studie
1 augusti 2006
Studieregistreringsdatum
Först inskickad
11 augusti 2005
Först inskickad som uppfyllde QC-kriterierna
11 augusti 2005
Första postat (Uppskatta)
12 augusti 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 juni 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 juni 2015
Senast verifierad
1 maj 2008
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- NHLICX3038
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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