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Trial record 6 of 118 for:    NHLBI | COPD

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)

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: NCT04521608
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : December 1, 2020
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:
This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.

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. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation.

The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study.

Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or telehealth-based PR).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : November 30, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention- Home Pulmonary Rehabilitation
Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching.
Behavioral: Intervention- Home-based 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).

No Intervention: Control- Choice
This arm receives the standard of care which includes the choice of PR at a facility or through telehealth. Center based PR involves attending a medical center gym where they can do exercises and receive disease specific education. Telehealth PR is delivered virtually through the computer or telephone.

Primary Outcome Measures :
  1. Adherence to Pulmonary Rehabilitation [ Time Frame: baseline to 3 months ]
    Percentage of Patients completing PR

Secondary Outcome Measures :
  1. Health Related Quality of Life as measured by the Chronic Respiratory Questionnaire (CRQ). [ Time Frame: baseline to 3 months ]
    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. Self Management [ Time Frame: baseline to 3 months ]
    The Self-Management Ability Scale (30) item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. 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. Daily Physical Activity [ Time Frame: baseline to 3 months ]
    Actigraph Activity Monitor will be worn for one week to measure daily steps, and time in sedentary mode, mild to moderate and vigorous physical activity.

  4. Health Care Utilization [ Time Frame: baseline to 3 months ]
    Number of ER and Hospital visits/days

  5. Duke-UNC Functional Social Support Questionnaire (FSSQ) [ Time Frame: baseline to 3 months ]
    8 item questionnaire that measures the amount of social support and availability of help from family and friends. The answers range from 1 "Much less than I would like" to 5 " As much as I would like". The scores from all 8 questions are summed (maximum 40) and then divided by 8 to get an average score. The higher the average score, the greater the perceived social support.

  6. Qualitative interviews [ Time Frame: After intervention (3 months) ]
    Investigate barriers and facilitators to PR adherence

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
  • Age 40+
  • Confidence (score > 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

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): NCT04521608

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Contact: Johanna Hoult, MA (507) 293-1989

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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Roberto P Benzo, MD Mayo Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic Identifier: NCT04521608    
Other Study ID Numbers: 18-002453 (Study 2/R33)
R61HL142933-02 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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