Home-based Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) (COPD-HOME)
This study is ongoing, but not recruiting participants.
Sponsor:
St. Olavs Hospital
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 19, 2008 | ||||
| Last Updated Date | October 17, 2011 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of hospitalizations [ Time Frame: 2011 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Number of hospitalizations ,quality of life [ Time Frame: 2011 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00702078 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
lung function, use of medication, cost-effectiveness [ Time Frame: 2011 ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Home-based Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Official Title ICMJE | Randomised Clinical Study on the Effect of Homebased Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System. | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | COPD | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2013 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
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| Gender | Both | ||||
| Ages | up to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00702078 | ||||
| Other Study ID Numbers ICMJE | 17417 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | St. Olavs Hospital | ||||
| Study Sponsor ICMJE | St. Olavs Hospital | ||||
| Collaborators ICMJE | Community Health Network | ||||
| Investigators ICMJE |
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| Information Provided By | St. Olavs Hospital | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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