Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comprehensive Disease Management Program to Improve Quality of Life in Disparity Hispanic and African-American Patients Admitted With Exacerbation of Chronic Pulmonary Diseases

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03007485
Recruitment Status : Active, not recruiting
First Posted : January 2, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Negin Hajizadeh, Northwell Health

Brief Summary:
Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause of hospitalization for older adults in the U.S., and a leading cause of death. Although there is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines exercise and education, can help decrease re-hospitalizations and improve patients' quality of life. Unfortunately, very few COPD Latino and African-American patients actually get PR. These patients are unlikely to get referrals or to be able to attend PR due to lack of insurance, lack of transportation, or lack of a PR center in their area. Telehealth is a way of using computers to deliver healthcare long-distance, eliminating the need for a patient to travel to receive care. By using telehealth for PR, the patient can exercise on a stationary bike in his or her home, while being supervised by videoconference by a respiratory therapist (RT). The RT can "see" the patient, and deliver education by videoconference, and the patient can "see" the RT, so the patient does not need to leave home to get PR.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Other: Telehealth Pulmonary Rehabilitation Not Applicable

Detailed Description:

Telehealth-delivered PR has been shown to be as effective as standard PR (patients go to an outpatient setting) at improving quality of life, and patients' exercise capacity. However, this has not been studied in the Latino and African-American population and it is not known how effective telehealth PR will be among this population.

For this study, the investigators hope to see if they can help COPD Latino and African-American patients with access to this needed resource through telehealth PR. They will compare standard PR and telehealth PR to determine if telehealth results in better outcomes for patients with moderate to severe COPD who were recently discharged from the hospital for COPD. The primary outcome the investigators will assess will be change in re-hospitalization rates. The secondary outcomes will include: change in quality of life, preparation to make decisions about clinical care, improved functional capacity, decreased dyspnea, anxiety, and depression.

The study will involve randomly assigning participants to make sure that they are just as likely to be in one group as the other to receive either: 1) referral for telehealth-delivered PR, or 2) referral to standard (outpatient) PR. Both PR programs consist of exercise and education twice a week for 8 weeks. The investigators will give the patients surveys to complete before they start the program and at the end of the program, to see if PR had any effect on the outcomes that are being measured. The investigators will enroll about 276 patients - with 138 patients in each group (telehealth PR or standard PR), so they can compare outcomes to see if telehealth PR was more, less, or equally effective as standard PR.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Comprehensive Disease Management Program to Improve Quality of Life in Disparity Hispanic and African-American Patients Admitted With Exacerbation of Chronic Pulmonary Diseases
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : June 15, 2019
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
Standard pulmonary rehabilitation
Experimental: Intervention
Telehealth delivered pulmonary rehabilitation
Other: Telehealth Pulmonary Rehabilitation
Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.




Primary Outcome Measures :
  1. Change in the rate of rehospitalizations in patients with COPD [ Time Frame: 6 months post-discharge from hospitalization following COPD exacerbation ]
    The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR).


Secondary Outcome Measures :
  1. Change in functional capacity after pulmonary rehabilitation [ Time Frame: Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation ]
    The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR, immediately following completion of PR, 6 months post-hospital discharge, and 12 months post-hospital discharge.

  2. Change in self-reported quality of life after pulmonary rehabilitation [ Time Frame: Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation ]
    The investigators will analyze the change in patients' quality of life based on self-reported outcome measurements, as measured prior to beginning PR, immediately following completion of PR, 6 months post-hospital discharge, 12 months post-hospital discharge.

  3. Measure of patients' adherence to completing pulmonary rehabilitation [ Time Frame: 8 weeks post-discharge from hospitalization following COPD exacerbation ]
    Given the improved convenience and access to PR, the investigators are looking to measure the degree to which patients adhere to their pulmonologists' referrals for pulmonary rehabilitation.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with a diagnosis of COPD (defined by one pulmonary function tests (PFT) and who have not done pulmonary rehabilitation within the past 1 year and
  • Hispanic or African-American (as defined by the patient him/herself).

Exclusion Criteria:

  • individuals who completed PR in the past year or
  • those unable to exercise or follow directions as determined by their outpatient pulmonologist/cardiologist or
  • A diagnosis of dementia listed in the patient's electronic medical record
  • Patients who weigh more than 300 pounds

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): NCT03007485


Locations
Layout table for location information
United States, New York
Northwell Health
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Negin Hajizadeh, MD, MPH Hofstra Northwell School of Medicine, Northwell Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Negin Hajizadeh, Associate Professor of Medicine, Northwell Health
ClinicalTrials.gov Identifier: NCT03007485    
Other Study ID Numbers: AD-1511-33066
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No