A Comprehensive Disease Management Program to Improve Quality of Life in Disparity Hispanic and African-American Patients Admitted With Exacerbation of Chronic Pulmonary Diseases
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|ClinicalTrials.gov Identifier: NCT03007485|
Recruitment Status : Active, not recruiting
First Posted : January 2, 2017
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Other: Telehealth Pulmonary Rehabilitation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|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|
No Intervention: Standard of Care
Standard pulmonary rehabilitation
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.
- 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).
- 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.
- 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.
- 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.
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
|United States, New York|
|Manhasset, New York, United States, 11030|
|Principal Investigator:||Negin Hajizadeh, MD, MPH||Hofstra Northwell School of Medicine, Northwell Health|