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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
synchronous interactive audio/video telecommunication
Sponsored by
Breathe California, Los Angeles County
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Telemedicine, Internet, Dyspnea, Self care, Breathing Exercises, Real-Time Systems

Eligibility Criteria

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

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.

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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.

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Sites / Locations

    Outcomes

    Primary Outcome Measures

    Dyspnea Intensity
    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?"

    Secondary Outcome Measures

    Full Information

    First Posted
    July 12, 2010
    Last Updated
    July 12, 2010
    Sponsor
    Breathe California, Los Angeles County
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01161290
    Brief Title
    Real-Time Telehealth to Promote Self-care Management for Chronic Obstructive Pulmonary Disease
    Acronym
    E-Breathe
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Breathe California, Los Angeles County

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease, Chronic Obstructive
    Keywords
    Telemedicine, Internet, Dyspnea, Self care, Breathing Exercises, Real-Time Systems

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    synchronous interactive audio/video telecommunication
    Other Intervention Name(s)
    Skype
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Dyspnea Intensity
    Description
    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?"
    Time Frame
    End of 4 weeks and end of 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margaret A Nield, PhD
    Organizational Affiliation
    Greater Los Angeles Healthcare System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Real-Time Telehealth to Promote Self-care Management for Chronic Obstructive Pulmonary Disease

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