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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00705302
First received: June 24, 2008
Last updated: February 3, 2012
Last verified: February 2012
  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
Chronic Obstructive Pulmonary Disease (COPD)
Behavioral: Group training with self-help group
Behavioral: Group training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial of the Effect of a Patient Education Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


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 ]

Enrollment: 88
Study Start Date: September 2007
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patient education including self-help
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
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.
Active Comparator: patient education
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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Norway
Department of Public Health and General Practice, Norwegian University of Science and Technology
Trondheim, Norway, N-7491
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Aslak Steinsbekk, PhD Norwegian University of Technology and Science
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00705302     History of Changes
Other Study ID Numbers: 10307300, 17732, 4.2007.2589
Study First Received: June 24, 2008
Last Updated: February 3, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Norwegian University of Science and Technology:
Chronic Obstructive Pulmonary Disease
Outpatient
Patient education
Pulmonary rehabilitation
Self-management

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014