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Home Pulmonary Rehabilitation for COPD

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
COPD Emphysema Behavioral: Home Based Pulmonary Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Official Title: Home Pulmonary Rehabilitation for COPD
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention
Patients randomized in this arm will start with the home based pulmonary rehabilitation program.
Behavioral: Home Based Pulmonary Rehabilitation
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.

Active Comparator: Control
Patients randomized in this arm will start the intervention after 12 weeks of usual care.
Behavioral: Home Based Pulmonary Rehabilitation
The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03480386


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Robert Crews    904-953-9559    crews.robert@mayo.edu   
United States, Minnesota
Health Partners Not yet recruiting
Minneapolis, Minnesota, United States, 55122
Contact: Charlene McEvoy, MD         
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Johanna Hoult, MA    507-293-1989    hoult.johanna@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Roberto P Benzo Mayo Clinic
Additional Information:
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Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03480386    
Other Study ID Numbers: 17-009449
R01HL140486-01 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto P. Benzo, Mayo Clinic:
Pulmonary Rehabilitation
Additional relevant MeSH terms:
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Emphysema
Pathologic Processes