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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

January 29, 2005
August 13, 2007
September 2003
Not Provided
  • Dyspnea
  • Exercise adherence and performance
  • Pulmonary exacerbations
Same as current
Complete list of historical versions of study NCT00102401 on ClinicalTrials.gov Archive Site
  • Perception of support
  • Self-efficacy for exercise and managing dyspnea
  • Health resource utilization
Same as current
Not Provided
Not Provided
 
Internet-Based and Established Dyspnea Self-Management Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Behavioral: Internet-based Dyspnea Self-Management Program
  • Behavioral: Face-to-face Dyspnea Self-Management Program
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2007
Not Provided

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102401
49153
Not Provided
Not Provided
Robert Wood Johnson Foundation
Not Provided
Principal Investigator: Virginia Carrieri-Kohlman, RN DNSc University of California, San Francisco
Principal Investigator: Huong Q Nguyen, RN PhD University of Washington
Robert Wood Johnson Foundation
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP