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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: Internet-based Dyspnea Self-Management Program; Behavioral: Face-to-face Dyspnea Self-Management Program	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
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
Study Start Date :	September 2003
Actual Study Completion Date :	June 2007

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Dyspnea
2. Exercise adherence and performance
3. Pulmonary exacerbations

Secondary Outcome Measures :

1. Perception of support
2. Self-efficacy for exercise and managing dyspnea
3. Health resource utilization

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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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
First Posted:	January 31, 2005
Last Update Posted:	August 14, 2007
Last Verified:	August 2007

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