Telehealth Pulmonary Rehabilitation for Hispanic and African-American Patients Admitted With Exacerbation of COPD

NCT03007485 | Completed Results

• 1 other identifier: AD-1511-33066
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge

  The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR). COPD Hospital Readmission were measured for Intention to Treat (ITT), medically cleared, and those who sat on the bike at least once. Composite of COPD hospital readmission or death within 6 months of discharge using all available (complete) data, and no imputation of missing data. Without adherence added, offset term omitted in the logistic regression.

  6 months post-discharge from hospitalization following COPD exacerbation

Secondary Outcomes (3)

• Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks

  Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)

• Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program

  Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation

• Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps

  Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)

Other Outcomes (1)

• Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session

  8 weeks post-discharge from hospitalization following COPD exacerbation

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard pulmonary rehabilitation

Intervention

EXPERIMENTAL

Telehealth delivered pulmonary rehabilitation

Other: Telehealth Pulmonary Rehabilitation

Interventions

Telehealth Pulmonary Rehabilitation OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Northwell Health

Manhasset, New York, 11030, United States

Location

Related Publications (2)

• Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

  PMID: 34495549 DERIVED

• Pekmezaris R, Kozikowski A, Pascarelli B, Wolf-Klein G, Boye-Codjoe E, Jacome S, Madera D, Tsang D, Guerrero B, Medina R, Polo J, Williams M, Hajizadeh N. A Telehealth-Delivered Pulmonary Rehabilitation Intervention in Underserved Hispanic and African American Patients With Chronic Obstructive Pulmonary Disease: A Community-Based Participatory Research Approach. JMIR Form Res. 2020 Jan 31;4(1):e13197. doi: 10.2196/13197.

  PMID: 32012039 DERIVED

Results Point of Contact

• Title: Dr. Negin Hajizadeh
• Organization: Northwell Health

Nhajizadeh@northwell.edu

516-600-1401

Study Officials

• Negin Hajizadeh, MD, MPH

  Hofstra Northwell School of Medicine, Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 2, 2017
• Study Start: April 1, 2017
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)