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

NCT00102401 | Completed

• 1 other identifier: 49153
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Pulmonary Disease, chronic obstructive; Lung disease, obstructive; Self-care; Self-management; Patient education

Outcome Measures

Primary Outcomes (3)

• Dyspnea

• Exercise adherence and performance

• Pulmonary exacerbations

Secondary Outcomes (3)

• Perception of support

• Self-efficacy for exercise and managing dyspnea

• Health resource utilization

Interventions

Internet-based Dyspnea Self-Management Program BEHAVIORAL

Face-to-face Dyspnea Self-Management Program BEHAVIORAL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active symptomatic illness other than COPD;
• Formal pulmonary rehabilitation training in the past 6 months

Sponsors & Collaborators

• Robert Wood Johnson Foundation: lead

Study Sites (2)

University of California

San Francisco, California, 94143-0610, United States

Location

University of Washington

Seattle, Washington, 98195-7266, United States

Location

Related Publications (7)

• Fu H, Garrett B, Tao G, Cordingley E, Ofoghi Z, Taverner T, Sun C, Cheung T. Virtual Reality-Guided Meditation for Chronic Pain in Patients With Cancer: Exploratory Analysis of Electroencephalograph Activity. JMIR Biomed Eng. 2021 Jun 24;6(2):e26332. doi: 10.2196/26332.

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• 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.

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• 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.

  PMID: 31934868 DERIVED

• 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.

  PMID: 30994471 DERIVED

• 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.

  PMID: 30855234 DERIVED

• 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.

  PMID: 25900904 DERIVED

• 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.

  PMID: 18417444 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Virginia Carrieri-Kohlman, RN DNSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Huong Q Nguyen, RN PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2005
• First Posted: January 31, 2005
• Study Start: September 1, 2003
• Study Completion: June 1, 2007
• Last Updated: August 14, 2007

Record last verified: 2007-08

Locations

US (2)