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

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00705302

Purpose

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).

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Behavioral: Pulmonary rehabilitation with self-help group - effect and costs	Phase II Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Controlled Trial of the Effect of a Patient Education Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

St. George's Respiratory Questionnaire (SGRQ) - Total score [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified Borg scale (MBS) pre, during and post 6MWT [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
Patient Activation Measure (PAM) [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
The Perceived Quality of Life Scale [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
6 minute walk test (6MWT) [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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: Pulmonary rehabilitation with self-help group - effect and costs The intervention will consist of a combined educational and exercise program and 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 in arm 1 will instead of five of the group training sessions, participate in a self-help group.
2: 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: Pulmonary rehabilitation with self-help group - effect and costs The intervention will consist of a combined educational and exercise program and 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 in arm 1 will instead of five of the group training sessions, participate in a self-help group.

Arms

Assigned Interventions

1: 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: Pulmonary rehabilitation with self-help group - effect and costs

The intervention will consist of a combined educational and exercise program and 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 in arm 1 will instead of five of the group training sessions, participate in a self-help group.

2: 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: Pulmonary rehabilitation with self-help group - effect and costs

The intervention will consist of a combined educational and exercise program and 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 in arm 1 will instead of five of the group training sessions, participate in a self-help group.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705302

Locations

Norway
Norwegian University of Technology and Science	Recruiting
Trondheim, Norway, 7489
Contact: Borghild K Lomundal, PhD student 47-7359-8823 borghild.k.lomundal@ntnu.no
Principal Investigator: Aslak Steinsbekk, PhD

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Study Director:

Aslak Steinsbekk, PhD

Norwegian University of Technology and Science

More Information

Responsible Party:	Norwegian University of Science and Technology ( Borghild Lomundal, PhD student )
Study ID Numbers:	10307300, NSD:17732, REK:4.2007.2589
Study First Received:	June 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705302
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian University of Science and Technology:

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

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009