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

January 9, 2017 updated by: St. Olavs Hospital

Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • Dept. of Lung Diseases, St.Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 95 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hospitalizations
Time Frame: 2011
2011

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: 2011
2011
lung function
Time Frame: 2011
2011
use of medication
Time Frame: 2011
2011
cost-effectiveness
Time Frame: 2011
2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Community Health Network

Investigators

  • Study Chair: Anne Hildur Henriksen, MD,PhD, St.Olavs Hospital HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17417

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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