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

• Sponsor: Helse Fonna (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02479841
• Collaborator: Helse Vest (Other), University of Stavanger (Other)
• Enrollment: 225
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD; Coping; Quality of Life	Other: Self management program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Health-promoting Competence, Coping and Quality of Life in Patients With COPD
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Oct 1, 2017
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Health promoting competence, HeiQ [Before, after, and 3,6 and 12 months after comlepting the intervention (self-management program)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of COPD, GOLD 2-4

• Speak and understand norwegian

• Adult

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helse Fonna	Haugesund		Norway	5504

Sponsors and Collaborators

• Helse Fonna
• Helse Vest
• University of Stavanger

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heidi B Bringsvor, PhD-candidate, Helse Fonna
• ClinicalTrials.gov Identifier: NCT02479841
• Other Study ID Numbers: HV911836
• First Posted: Jun 24, 2015
• Last Update Posted: Feb 26, 2018
• Last Verified: Feb 1, 2018

Study Results

No Results Posted as of Feb 26, 2018