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

This study has been completed.
Sponsor:
Information provided by:
Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:
NCT00102401
First received: January 29, 2005
Last updated: August 13, 2007
Last verified: August 2007
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Behavioral: Internet-based Dyspnea Self-Management Program
Behavioral: Face-to-face Dyspnea Self-Management Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Robert Wood Johnson Foundation:

Primary Outcome Measures:
  • Dyspnea
  • Exercise adherence and performance
  • Pulmonary exacerbations

Secondary Outcome Measures:
  • Perception of support
  • Self-efficacy for exercise and managing dyspnea
  • Health resource utilization

Enrollment: 50
Study Start Date: September 2003
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102401

Locations
United States, California
University of California
San Francisco, California, United States, 94143-0610
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-7266
Sponsors and Collaborators
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Virginia Carrieri-Kohlman, RN DNSc University of California, San Francisco
Principal Investigator: Huong Q Nguyen, RN PhD University of Washington
  More Information

No publications provided by Robert Wood Johnson Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00102401     History of Changes
Other Study ID Numbers: 49153
Study First Received: January 29, 2005
Last Updated: August 13, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Robert Wood Johnson Foundation:
Chronic obstructive pulmonary disease
Pulmonary Disease, chronic obstructive
Lung disease, obstructive
 Self-care
Self-management
Patient education

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013