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Real-Time Telehealth to Promote Self-care Management for Chronic Obstructive Pulmonary Disease (E-Breathe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01161290
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : July 13, 2010
Information provided by:
VA Greater Los Angeles Healthcare System

Brief Summary:

HYPOTHESIS:The study purpose is to evaluate the effectiveness of a structured pursed-lips breathing (PLB) protocol taught via real-time interactive telecommunication with a home computer using the lnternet and Skype software in veterans with chronic obstructive pulmonary disease (COPD. The primary hypothesis is veterans with COPD and dyspnea on exertion who receive a PLB educational intervention taught via weekly interactive telecommunication over a 4-week period will have greater reduction of exertional dyspnea compared to those who receive the PLB educational intervention with no weekly interactive sessions.

RESEARCH PLAN: An experimental two- group design is used. All subjects receive a brief 5 - 10 minute one-on-one PLB educational session. Subjects are then randomized to either the intervention group or the control group. The intervention group receives 4 weekly interactive group sessions with the health educator (principal investigator)via computer. A free software program known as Skype allows synchronous video and audio interaction. The comparison group receives only the brief PLB educational session with no weekly follow-up.

RESULTS: At end of 4 weeks, the intervention group had significantly lower dyspnea intensity scores (group X time interaction F = 6.69, p = 0.02) and significantly higher social support scores (group x time interaction F = 4.34, p = 0.058).

CLINICAL SIGNIFICANCE: Skype is a viable means for providing patient education. A structured PLB protocol provides significant differences in exertional dyspnea over time. A structured PLB protocol plus Skype showed significant reduction in patients' sense of dyspnea intensity and increased social support scores.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: synchronous interactive audio/video telecommunication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Using Real-Time Interactive Audio/Visual Telehealth to Promote Self-care Management for United States Veterans With Chronic Obstructive Pulmonary Disease: a Pilot Study
Study Start Date : September 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: synchronous interactive audio/video telecommunication
    4 weekly synchronous interactive audio/video sessions on self-care management for dyspnea provided via the Internet and free downloadable software (Skype) on patients' home computer
    Other Name: Skype

Primary Outcome Measures :
  1. Dyspnea Intensity [ Time Frame: End of 4 weeks and end of 12 weeks ]
    Dyspnea Intensity is measured with the Visual Analogue Scale. The scale is a 100-cm horizontal line with verbal anchors at either end. Interval level data are obtained by measuring from left to the point marked by the subject. The subjects mark the scale with a pencil in response to the question, "During the last 24 hours, how easy or how hard was it to get your breath?"

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Clinical diagnosis of COPD, expiratory airflow limitation evidenced by forced expiratory volume 1 second/forced vital capacity percent (FEV1/FVC %) less than 70 and FEV1 % predicted less than 80 with no reversibility by inhaled bronchodilator, and self report of shortness of breath when walking as assessed with the modified Medical Research Council (MRC) chronic dyspnea questionnaire.


Exclusion Criteria:

Exacerbation of symptoms (dyspnea, increased sputum volume, and/or increased sputum purulence) within the past four weeks, hospital admission within the past four weeks, change in bronchodilator therapy within the past two weeks, unable to walk, unstable angina, unstable cardiac dysrhythmia, unstable congestive heart failure, and/or unstable neurosis or psychiatric disturbance.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01161290

Sponsors and Collaborators
Breathe California, Los Angeles County
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Principal Investigator: Margaret A Nield, PhD Greater Los Angeles Healthcare System

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Responsible Party: Margaret Nield, Greater Los Angeles Healthcare System, West Los Angeles Identifier: NCT01161290     History of Changes
Other Study ID Numbers: Nield005
BBRI 900.1553 ( Other Grant/Funding Number: Breathe California, Los Angeles County )
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: July 13, 2010
Last Verified: July 2010

Keywords provided by VA Greater Los Angeles Healthcare System:
Self care
Breathing Exercises
Real-Time Systems

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes