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

Sponsored by:	Robert Wood Johnson Foundation
Information provided by:	Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:	NCT00102401

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

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Additional Information:

web site provides more information about this study This link exits the ClinicalTrials.gov site

No publications provided by Robert Wood Johnson Foundation

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Nguyen HQ, Donesky-Cuenco D, Wolpin S, Reinke LF, Benditt JO, Paul SM, Carrieri-Kohlman V. Randomized controlled trial of an internet-based versus face-to-face dyspnea self-management program for patients with chronic obstructive pulmonary disease: pilot study. J Med Internet Res. 2008 Apr 16;10(2):e9.

Study ID Numbers:	49153
Study First Received:	January 29, 2005
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00102401 History of Changes
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

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Dyspnea
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009