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

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

Tracking Information
First Submitted Date  ICMJE January 29, 2005
First Posted Date  ICMJE January 31, 2005
Last Update Posted Date August 14, 2007
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Dyspnea
  • Exercise adherence and performance
  • Pulmonary exacerbations
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00102401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Perception of support
  • Self-efficacy for exercise and managing dyspnea
  • Health resource utilization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet-Based and Established Dyspnea Self-Management Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Behavioral: Internet-based Dyspnea Self-Management Program
  • Behavioral: Face-to-face Dyspnea Self-Management Program
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2007)
50
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
100
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00102401
Other Study ID Numbers  ICMJE 49153
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Robert Wood Johnson Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Virginia Carrieri-Kohlman, RN DNSc University of California, San Francisco
Principal Investigator: Huong Q Nguyen, RN PhD University of Washington
PRS Account Robert Wood Johnson Foundation
Verification Date August 2007

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