Clinical trial NCT00705302: Patient Education in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Effect and Costs
Official title: A Randomised Controlled Trial of the Effect of a Patient Education Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
Outpatient
Patient education
Pulmonary rehabilitation
Self-management
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2008-06-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Pulmonary rehabilitation is aimed to increase the level of health of patients with COPD by increasing their self care ability. A recent updated systematic review concluded that evidence strongly supports respiratory rehabilitation as part of the spectrum of management of patients with chronic obstructive pulmonary disease (COPD). Studies of pulmonary rehabilitation programs lasting up to 18 months show that effects are mainly maintained throughout the duration of the program. The long term effect, however, is mostly studied for programs of shorter durations. Some of the studies with shorter duration have found that the achieved benefit was lost or diminished during the follow up period, while others have found that the effect has been maintained up to 18 months. Our necessity in the rehabilitative field is to find strategies to maintain benefits during time.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* contraindications for physical activity

Primary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ) - Total score
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Modified Borg scale (MBS) pre, during and post 6MWT
timeFrame: Baseline, 3, 6 and 12 months
measure: Patient Activation Measure (PAM)
timeFrame: Baseline, 3, 6 and 12 months
measure: The Perceived Quality of Life Scale
timeFrame: Baseline, 3, 6 and 12 months
measure: 6 minute walk test (6MWT)
timeFrame: Baseline, 3, 6 and 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Public Health and General Practice, Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Technology and Science
name: Aslak Steinsbekk, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.