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Trial record 6 of 109 for:    NHLBI | COPD

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

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. Identifier: NCT03865329
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:
This study will look at the effectiveness of a home-based Pulmonary Rehabilitation Program in patients who have recently been hospitalized for a COPD related cause.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Behavioral: Intervention- Home-based Pulmonary Rehabilitation Not Applicable

Detailed Description:

Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. In particular PR post-hospitalization has been reported as the most effective intervention to prevent a hospital readmission; however, the reality is that many times this is not a feasible intervention as only 4% of eligible individuals are able to adhere to PR after a hospital admission (for multiple reasons).While COPD is responsible for nearly 700,000 hospitalizations annually, many of these hospitalizations, which account for a large proportion of the annual direct medical costs of COPD, are potentially preventable readmissions.

In this study we plan to add Health Coaching to PR to promote a behavior change to decrease COPD re-hospitalizations and sustainably improve QOL. We propose a simple system of Remote PR that may fill the practice gap.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
Actual Study Start Date : January 20, 2018
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention- Home Pulmonary Rehabilitation
Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
Behavioral: Intervention- Home-based Pulmonary Rehabilitation
Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching.

No Intervention: Control- Usual Care
This arm receives the standard of care which may include PR at a facility. Traditional PR involves attending a medical center gym where they can do exercises and receive disease specific education.

Primary Outcome Measures :
  1. Adherence to Pulmonary Rehabilitation [ Time Frame: Year 1-5 ]
    Percentage of Patients completing PR

Secondary Outcome Measures :
  1. Health Related Quality of Life as measured by the Chronic Respiratory Questionnaire (CRQ). [ Time Frame: Years 2-5 ]
    The CRQ will be completed by participants several times during the study. The questionnaire measures health related quality of life and is a validated tool. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. Higher scores indicate better health related quality of life. (numerical, 1-7 point Likert Scale, emotional and physical summary scores will be reported )

  2. To determine and compare cost-effectiveness between the 2 arms proposed: subject referred to home-based PR program compared to subjects referred to conventional center-based PR [ Time Frame: Years 2-5 ]
    The EuroQol Five Dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. The health status measured with EQ-5D is used for estimating preference weight for that health status, then, by combining the weight with time, a quality-adjusted life year (QALY) can be computed. QALYs gained its used as an outcome in the cost-utility analysis, which is a type of economic evaluation that compares the benefit and cost of healthcare programs or interventions. EQ-5D is one of the most commonly used generic health status measurements, and its good validity and reliability have been reported in various health conditions. It will be the tool to be used in the proposed cost-effectiveness analysis (CEA). The EQ-5D is a 1 -5 digit scale in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The 5 digit number obtained is translated into a health status score.

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

Inclusion Criteria

  • COPD related hospitalization and eligible for PR
  • Exclusion Criteria
  • Inability to walk (orthopedic-neurologic problems or confined to bed)

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): NCT03865329

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Contact: Johanna Hoult, MA 5072931989

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Johanna Hoult, MA    507-293-1989   
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
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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 Identifier: NCT03865329    
Other Study ID Numbers: 18-002453
R61HL142933 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No