search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Group training with self-help group
Group training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, Outpatient, Patient education, Pulmonary rehabilitation, Self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patient education including self-help

patient education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Modified Borg scale (MBS) pre, during and post 6MWT
Patient Activation Measure (PAM)
The Perceived Quality of Life Scale
6 minute walk test (6MWT)

Full Information

First Posted
June 24, 2008
Last Updated
February 10, 2017
Sponsor
Norwegian University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT00705302
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease, Outpatient, Patient education, Pulmonary rehabilitation, Self-management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient education including self-help
Arm Type
Experimental
Arm Description
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.
Arm Title
patient education
Arm Type
Active Comparator
Arm Description
Patients in arm 2 will participate in the same patient education and exercise program as arm 1, but without an additional self-help group.
Intervention Type
Behavioral
Intervention Name(s)
Group training with self-help group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group training
Intervention Description
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.
Primary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire (SGRQ) - Total score
Time Frame
Baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Modified Borg scale (MBS) pre, during and post 6MWT
Time Frame
Baseline, 3, 6 and 12 months
Title
Patient Activation Measure (PAM)
Time Frame
Baseline, 3, 6 and 12 months
Title
The Perceived Quality of Life Scale
Time Frame
Baseline, 3, 6 and 12 months
Title
6 minute walk test (6MWT)
Time Frame
Baseline, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslak Steinsbekk, PhD
Organizational Affiliation
Norwegian University of Technology and Science
Official's Role
Study Director
Facility Information:
Facility Name
Department of Public Health and General Practice, Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
N-7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
18268936
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.
Results Reference
background
PubMed Identifier
22371649
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs