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

• ClinicalTrials.gov Identifier: NCT00102401
• Recruitment Status: Completed
• First Posted: January 31, 2005
• Last Update Posted: August 14, 2007
• Sponsor: Robert Wood Johnson Foundation
• Information provided by: Robert Wood Johnson Foundation

Study Description

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

• 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

Outcome Measures

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

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• 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

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

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

Chung A, Seixas A, Williams N, Senathirajah Y, Robbins R, Newsome Garcia V, Ravenell J, Jean-Louis G. Development of "Advancing People of Color in Clinical Trials Now!": Web-Based Randomized Controlled Trial Protocol. JMIR Res Protoc. 2020 Jul 14;9(7):e17589. doi: 10.2196/17589.

Greysen SR, Magan Y, Rosenthal J, Jacolbia R, Auerbach AD, Harrison JD. Patient Recommendations to Improve the Implementation of and Engagement With Portals in Acute Care: Hospital-Based Qualitative Study. J Med Internet Res. 2020 Jan 14;22(1):e13337. doi: 10.2196/13337.

Arostegui I, Legarreta MJ, Barrio I, Esteban C, Garcia-Gutierrez S, Aguirre U, Quintana JM; IRYSS-COPD Group. A Computer Application to Predict Adverse Events in the Short-Term Evolution of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease. JMIR Med Inform. 2019 Apr 17;7(2):e10773. doi: 10.2196/10773.

Abbott-Garner P, Richardson J, Jones RB. The Impact of Superfast Broadband, Tailored Booklets for Households, and Discussions With General Practitioners on Personal Electronic Health Readiness: Cluster Factorial Quasi-Randomized Control Trial. J Med Internet Res. 2019 Mar 11;21(3):e11386. doi: 10.2196/11386.

McHugh J, Lee O, Aspell N, Lawlor BA, Brennan S. A shared mealtime approach to improving social and nutritional functioning among older adults living alone: study protocol for a randomized controlled trial. JMIR Res Protoc. 2015 Apr 21;4(2):e43. doi: 10.2196/resprot.4050.

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
• 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