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Home-based Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) (COPD-HOME)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Community Health Network
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00702078
First received: June 19, 2008
Last updated: October 17, 2011
Last verified: October 2011
History of Changes
  Purpose

We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.

The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.


Condition Intervention
COPD
 Behavioral: closer collaboration between hospital and primary healthcare system
Behavioral: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Clinical Study on the Effect of Homebased Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Number of hospitalizations [ Time Frame: 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 2011 ] [ Designated as safety issue: No ]
  • lung function [ Time Frame: 2011 ] [ Designated as safety issue: No ]
  • use of medication [ Time Frame: 2011 ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
usual care
follow-up according to todays best practice.
 Behavioral: usual care
follow-up according to todays best practice
Experimental: cooperation
Follow-up from the hospital and the primary healthcare in cooperation
 Behavioral: closer collaboration between hospital and primary healthcare system
Follow-up from the hospital and the primary healthcare in cooperation

  Eligibility

Ages Eligible for Study:   up to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of COPD (III-IV)
  • receive help from homecare nurse
  • not suffering from any other serious disease, with expected lifespan less than 6 months

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702078

Locations
Norway
Dept. of Lung Diseases, St.Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Community Health Network
Investigators
Study Chair: Anne Hildur Henriksen, MD,PhD St.Olavs Hospital HF
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00702078     History of Changes
Other Study ID Numbers: 17417
Study First Received: June 19, 2008
Last Updated: October 17, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:
COPD
home-based treatment
early intervention

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

ClinicalTrials.gov processed this record on May 19, 2013