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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

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE March 6, 2019
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE January 20, 2018
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Adherence to Pulmonary Rehabilitation [ Time Frame: Year 1-5 ]
Percentage of Patients completing PR
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • 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 )
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
Official Title  ICMJE Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COPD Exacerbation
Intervention  ICMJE Behavioral: Intervention- Home-based Pulmonary Rehabilitation
Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Intervention- Home-based Pulmonary Rehabilitation
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2023
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • COPD related hospitalization and eligible for PR
  • Exclusion Criteria
  • Inability to walk (orthopedic-neurologic problems or confined to bed)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johanna Hoult, MA 5072931989
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03865329
Other Study ID Numbers  ICMJE 18-002453
R61HL142933 ( 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 March 2019

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