NCT02479841

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

January 22, 2014

Last Update Submit

January 9, 2024

Conditions

COPDCopingQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Change in Health promoting competence, HeiQ

    Before, after, and 3,6 and 12 months after comlepting the intervention (self-management program)

Study Arms (2)

self management program

EXPERIMENTAL

Participation in an 11 week self-management program

Other: Self management program

Control group

NO INTERVENTION

Interventions

Self management programOTHER
self management program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helse Fonna

Haugesund, 5504, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Signe B Bentsen, PhDProfessor

    University of Stavanger, Norway

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-candidate

Study Record Dates

First Submitted

January 22, 2014

First Posted

June 24, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2017

Study Completion

December 1, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

NO(1)