Chronic Obstructive Pulmonary DiseaseNCT00102401
Internet-Based and Established Dyspnea Self-Management Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Internet-based Dyspnea Self-Management Program and Face-to-face Dyspnea Self-Management Program in people with Chronic Obstructive Pulmonary Disease, run by Robert Wood Johnson Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Internet-based Dyspnea Self-Management Program and Face-to-face Dyspnea Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active symptomatic illness other than COPD;
- Formal pulmonary rehabilitation training in the past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California
San Francisco, California, 94143-0610
University of Washington
Seattle, Washington, 98195-7266
About this study
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
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Internet-based Dyspnea Self-Management Program, Face-to-face Dyspnea Self-Management Program
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary Disease, chronic obstructive, Lung disease, obstructive, Self-care, Self-management, Patient education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Dyspnea Self-Management ProgramBehavioural
Face-to-face Dyspnea Self-Management ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Exercise adherence and performance
Pulmonary exacerbations
Secondary outcomes (3)
Perception of support
Self-efficacy for exercise and managing dyspnea
Health resource utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2005 (estimated)
- Study startSep 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Virginia Carrieri-Kohlman, RN DNSc, Principal investigator, University of California, San FranciscoHuong Q Nguyen, RN PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102401
- Sponsor's protocol ID
- 49153
- Status last verified
- Aug 2007
- First submitted
- 29 Jan 2005
- Last updated
- 14 Aug 2007
- Results posted
- No
Publications
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.
PubMed 38907380Chung 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.
PubMed 32673274Greysen 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.
PubMed 31934868Arostegui 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.
PubMed 30994471Abbott-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.
PubMed 30855234McHugh 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.
PubMed 25900904Nguyen 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.
PubMed 18417444
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00102401
- Acronym / sponsor ID
- 49153
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary Disease, chronic obstructive, Lung disease, obstructive, Self-care, Self-management, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 31 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (2 listed)
- Active symptomatic illness other than COPD;
- Formal pulmonary rehabilitation training in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Dyspnea Self-Management Program | Behavioural | – |
| Face-to-face Dyspnea Self-Management Program | Behavioural | – |
Primary outcome
Dyspnea
Exercise adherence and performance
Pulmonary exacerbations
3 secondary outcomes
Perception of support
Self-efficacy for exercise and managing dyspnea
Health resource utilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2007.
- Derived from this study: PubMed 38907380Fu 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.
- Derived from this study: PubMed 32673274Chung 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.
- Derived from this study: PubMed 31934868Greysen 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.
- Derived from this study: PubMed 30994471Arostegui 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.
- Derived from this study: PubMed 30855234Abbott-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.
- Derived from this study: PubMed 25900904McHugh 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.
- Derived from this study: PubMed 18417444Nguyen 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.
Related trials for Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Carrieri-Kohlman, RN DNSc principal investigator
University of California, San Francisco
Huong Q Nguyen, RN PhD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Dyspnea Self-Management Program and Face-to-face Dyspnea Self-Management Program in people with Chronic Obstructive Pulmonary Disease, run by Robert Wood Johnson Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00102401, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2007.