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Home Pulmonary Rehabilitation for COPD

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ClinicalTrials.gov Identifier: NCT03480386
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Participants on home-based PR will have higher quality of life at month three after randomization than participants in the waitlist control group. [ Time Frame: baseline, 3 months. ]
Participants will complete quality of life questionnaires at enrollment and at 3 months. The Chronic Respiratory Questionnaire (CRQ) will be utilized to measure quality of life. The intervention participants will have a change in quality of life.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2020)
  • Daily Physical Activity will be measured and compared between baseline and three months [ Time Frame: baseline and 3 months ]
    Actigraph GT3X is the validated tool to measure physical activity. The Actigraph will be worn for one week to measures sedentary time, daily step, and time in sedentary mode, and mild-moderate and vigorous physical activity.
  • Self-Management [ Time Frame: baseline and 3 months ]
    Self-Management Ability Scale-30 item questionnaire measuring ability and function. A higher score indicates higher function and ability.The SMAS consists of 30 items on four- and five-point Likert scales. Scores on the subscales and the total score are transformed into scores ranging from 0 to 100 (higher number is best). Each question has a range from 1-5.
  • Depression [ Time Frame: baseline and 3 months ]
    Patient Health Questionnaire-9 item questionnaire screening for depression. A higher score indicates that depression may be present. Scores range from 0-27.
  • Social Support [ Time Frame: baseline and 3 months ]
    The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other.- 12 item questionnaire with a range of 12-84. A higher score indicates a greater amount of social support.
  • Meaning in Life [ Time Frame: baseline and 3 month ]
    Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.
  • Sleep Quality [ Time Frame: baseline and 3 month ]
    Sleep Quality Assessment - 9 item questionnaire measuring the quality and patterns of sleep. Scores range from 0 to 21. A lower score suggests a better quality of sleep.
  • Anxiety [ Time Frame: baseline and 3 month ]
    General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0-6, a higher score suggests that anxiety is present.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Daily Physical Activity will be measured and compared between baseline and three months [ Time Frame: baseline and 3 months ]
Actigraph GT3X is the validated tool to measure physical activity. The Actigraph will be worn for one week to measures sedentary time. Sedentary time will be higher in the controlled group after the intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Pulmonary Rehabilitation for COPD
Official Title  ICMJE Home Pulmonary Rehabilitation for COPD
Brief Summary While pulmonary rehabilitation provides benefits to people with COPD, only 25% have access to pulmonary rehabilitation each year. The main barriers are related to travel and transportation. This protocol will evaluate the effect of a home-based rehabilitation system on quality of life and steps. The system allows for monitoring by a health care system. A health coach will review the data and provide coaching to facilitate behavioral change and self-efficacy.
Detailed Description This study will test the effectiveness of a home-base pulmonary rehabilitation program, that includes off-the-shelf technology (Android computer tablet, Nonin pulse oximeter and Garmin Fitness Tracker), health coaching and an online platform that allows a health coach to review patient monitoring and progress. The comparison will be a wait-list control group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume [FEV1] <50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale [mMRC] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • COPD
  • Emphysema
Intervention  ICMJE Behavioral: Home Based Pulmonary Rehabilitation
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.
Study Arms  ICMJE
  • Experimental: Intervention
    Patients randomized in this arm will start with the home based pulmonary rehabilitation program.
    Intervention: Behavioral: Home Based Pulmonary Rehabilitation
  • Active Comparator: Control
    Patients randomized in this arm will start the intervention after 12 weeks of usual care.
    Intervention: Behavioral: Home Based Pulmonary Rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Clinical diagnosis of COPD,
  • Age ≥40 years
  • Current or previous smoker (≥10 packs per year)
  • Confidence in using the proposed PR system
  • English or Spanish language fluency

Exclusion Criteria

  • Unable or unwilling to do Rehabilitation due to physical conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03480386
Other Study ID Numbers  ICMJE 17-009449
R01HL140486-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roberto P. Benzo, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Roberto P Benzo Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP