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

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:

MedlinePlus related topics: Breathing Problems COPD Exercise and Physical Fitness Lung Diseases

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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. doi: 10.2196/jmir.990.


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:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Dyspnea	Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016