Health-promoting Competence, Coping and Quality of Life in Patients With COPD (REKV-13/1741)

January 9, 2024 updated by: Heidi B Bringsvor, Helse Fonna

Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and disability, and by 2020, it is expected to be the third leading cause of mortality worldwide. COPD is a major public health concern and has considerable impact on health and quality of life.

For this study an evidence based self-management program is developed, the purpose of the study is to see if this self-management program, in collaboration between specialized health services and municipality health services, improves patients with COPD health-promoting competence, coping and quality of life, and reduces health service costs.The study has a RCT design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

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
      • Haugesund, Norway, 5504
        • Helse Fonna

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of COPD, GOLD 2-4
  • Speak and understand norwegian
  • Adult

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: self management program
Participation in an 11 week self-management program
Other: Self management program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Health promoting competence, HeiQ
Time Frame: Before, after, and 3,6 and 12 months after comlepting the intervention (self-management program)
Before, after, and 3,6 and 12 months after comlepting the intervention (self-management program)

Collaborators and Investigators

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

Sponsor

Helse Fonna

Collaborators

Helse Vest
University of Stavanger

Investigators

  • Study Director: Signe B Bentsen, PhDProfessor, University of Stavanger, Norway

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

February 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimated)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HV911836

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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