Internet-Based and Established Dyspnea Self-Management Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00102401
• Lead Sponsor: Robert Wood Johnson Foundation

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted QC: 2005-01-28
• Study First Submitted: 2005-01-29
• Study First Posted: 2005-01-31
• Study Completion: 2007-06
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-13
• Last Update Posted: 2007-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary exacerbations
Dyspnea
Exercise adherence and performance

Secondary Outcome Measures

Name	Time	Method
Perception of support
Self-efficacy for exercise and managing dyspnea
Health resource utilization

Trial Locations

Locations (2)

University of California; 🇺🇸 San Francisco, California, United States

University of Washington; 🇺🇸 Seattle, Washington, United States