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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based Dyspnea Self-Management Program
Face-to-face Dyspnea Self-Management Program
Sponsored by
Robert Wood Johnson Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Pulmonary Disease, chronic obstructive, Lung disease, obstructive, Self-care, Self-management, Patient education

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California
  • University of Washington

Outcomes

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

Full Information

First Posted
January 29, 2005
Last Updated
August 13, 2007
Sponsor
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00102401
Brief Title
Internet-Based and Established Dyspnea Self-Management Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients
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 Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Robert Wood Johnson Foundation

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, Pulmonary Disease, chronic obstructive, Lung disease, obstructive, Self-care, Self-management, Patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Internet-based Dyspnea Self-Management Program
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face Dyspnea Self-Management Program
Primary Outcome Measure Information:
Title
Dyspnea
Title
Exercise adherence and performance
Title
Pulmonary exacerbations
Secondary Outcome Measure Information:
Title
Perception of support
Title
Self-efficacy for exercise and managing dyspnea
Title
Health resource utilization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Carrieri-Kohlman, RN DNSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huong Q Nguyen, RN PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0610
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-7266
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32673274
Citation
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.
Results Reference
derived
PubMed Identifier
31934868
Citation
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.
Results Reference
derived
PubMed Identifier
30994471
Citation
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.
Results Reference
derived
PubMed Identifier
30855234
Citation
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.
Results Reference
derived
PubMed Identifier
25900904
Citation
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.
Results Reference
derived
PubMed Identifier
18417444
Citation
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.
Results Reference
derived

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

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