Patient Education in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Effect and Costs

NCT00705302 | Completed DMC

• 3 other identifiers: 10307300177324.2007.2589
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the long term effect of a self-help group in a patient education program for patients with chronic obstructive pulmonary disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; Outpatient; Patient education; Pulmonary rehabilitation; Self-management

Outcome Measures

Primary Outcomes (1)

• St. George's Respiratory Questionnaire (SGRQ) - Total score

  Baseline, 3, 6 and 12 months

Secondary Outcomes (4)

• Modified Borg scale (MBS) pre, during and post 6MWT

  Baseline, 3, 6 and 12 months

• Patient Activation Measure (PAM)

  Baseline, 3, 6 and 12 months

• The Perceived Quality of Life Scale

  Baseline, 3, 6 and 12 months

• 6 minute walk test (6MWT)

  Baseline, 3, 6 and 12 months

Study Arms (2)

patient education including self-help

EXPERIMENTAL

Patients in the arm will participate in a three months patient education and exercise program including a self-help group in 3 months of time.

Behavioral: Group training with self-help group

patient education

ACTIVE COMPARATOR

Patients in arm 2 will participate in the same patient education and exercise program as arm 1, but without an additional self-help group.

Behavioral: Group training

Interventions

Group training with self-help group BEHAVIORAL

Combined educational and exercise program for pulmonary rehabilitation, with (1) or without(2 a self-help group. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group. Patients will instead of five of the group training sessions, participate in a self-help group.

patient education including self-help

Group training BEHAVIORAL

Combined educational and exercise program for pulmonary rehabilitation. The educational part consists firstly of two days with group meetings with information from medical doctor, pharmacist, psychologist, ergonomist, nurse, social worker, physiotherapist and a clinical nutritional physiologist. One more day will be held after 3 months and it is the participants themselves who decide on the content of these days. An experienced patient will participate throughout the course. The exercise part consists of group training twice a week for 3 months with 10-15 participants in each group.

patient education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (FEV1) lower that 75% of predicted
• the ability to participate in physical activity
• not been hospitalized the last month.

You may not qualify if:

• contraindications for physical activity

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Department of Public Health and General Practice, Norwegian University of Science and Technology

Trondheim, N-7491, Norway

Location

Related Publications (2)

• Lomundal BK, Steinsbekk A. Observational studies of a one year self-management program and a two year pulmonary rehabilitation program in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2007;2(4):617-24.

  PMID: 18268936 BACKGROUND

• Lomundal BK, Steinsbekk A. Five-year follow-up of a one-year self-management program for patients with COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:87-93. doi: 10.2147/COPD.S27352. Epub 2012 Feb 9.

  PMID: 22371649 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Self-Help Groups; Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Aslak Steinsbekk, PhD

  Norwegian University of Technology and Science

  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: SPONSOR

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

NO (1)