Skip to main content
Clinical Trials/NCT00102401
NCT00102401
Completed
Not Applicable

Comparing the Effects of an Internet-Based to an Established Dyspnea Self-Management Program on Dyspnea, Exercise Behavior, and Pulmonary Exacerbations in Patients With COPD

Robert Wood Johnson Foundation2 sites in 1 country50 target enrollmentSeptember 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Robert Wood Johnson Foundation
Enrollment
50
Locations
2
Primary Endpoint
Pulmonary exacerbations
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

The overall goal of this study is to compare the impact of a new Internet Dyspnea Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management Program (DSMP) in patients with COPD. The primary aim of the study is to test the following two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes of perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

Detailed Description

Despite optimal medical treatment, people with chronic obstructive pulmonary disease (COPD) continue to experience dyspnea or shortness of breath. This study will evaluate two different ways to provide education and support to help patients manage their shortness of breath. One program will be conducted in a face-to-face setting and a second through the Internet. The main difference between the two programs is the way they are administered. The education, exercise, and monitoring components are the same. The overall goal of this study is to find out whether the two programs are comparable in their effect on shortness of breath (dyspnea) with activities of daily living, exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. Perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization will also be measured at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
June 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Robert Wood Johnson Foundation

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of COPD, clinically stable for 1 month;
  • Spirometry results showing at least mild disease (FEV1/FVC \< 70% and FEV1 \< 80% predicted after bronchodilator);
  • ADL limited by dyspnea;
  • Ability to speak English and sign consent form;
  • Actively use computer and the Internet;
  • Maintain O2 saturation \> 85% on \< 6 L/min of nasal oxygen during the six minute walk;
  • Understands and is able to rate shortness of breath during exercise

Exclusion Criteria

  • Active symptomatic illness other than COPD;
  • Formal pulmonary rehabilitation training in the past 6 months

Outcomes

Primary Outcomes

Pulmonary exacerbations

Dyspnea

Exercise adherence and performance

Secondary Outcomes

  • Perception of support
  • Self-efficacy for exercise and managing dyspnea
  • Health resource utilization

Study Sites (2)

Loading locations...

Similar Trials