COPD ExacerbationNCT03007485

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

A study testing Telehealth Pulmonary Rehabilitation in people with COPD Exacerbation, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COPD Exacerbation
What is being tested?: Telehealth Pulmonary Rehabilitation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2017to 15 Nov 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwell Health
Manhasset, New York, 11030

Other trials in United States

About this study

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

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.

Read the 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. Patients will also be asked to participate in a qualitative interview and focus group to learn about the barriers they encountered even after receiving a referral to PR. These qualitative interviews will be conducted among a sample of participants representing those who withdrew, were lost-to-follow-up, completed PR and decided to only complete the surveys (i.e. not participate in PR).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.

Conditions: COPD Exacerbation
Being tested: Telehealth Pulmonary Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telehealth Pulmonary RehabilitationOther
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.

Study groups in NCT03007485
Study group	Role	What they receive
Standard of Care	No intervention	Standard pulmonary rehabilitation
Intervention	Experimental	Telehealth delivered pulmonary rehabilitation Receives: Other: Telehealth Pulmonary Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.
Measured: 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
The investigators will analyze the change in patients' quality of life based on self-reported outcome measurements, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks), 6 months post-hospital discharge, 12 months post-hospital discharge.
COPD Assessment Test (CAT): Maximal Score: 40, Minimal Score: 0; lower score denotes improvement
Modified Medical Research Council Scale (MMRC): Maximal Score: 4, Minimal Score: 0; lower score denotes improvement
All PROMIS scales have a maximal score of 20 and minimal score for all scales is 4; lower score denotes improvement.
Measured: 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
The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR (Day 1), immediately following completion of PR (8 weeks). This measures the length the study participant walked/step (i.e. 2-minute step test (2MST)= how many steps the participant took, 6-minute walk test (6MWT)= the length the participant walked for in meters). Due to the limited space in TelePR participants home, they were only able to complete the 2MST, while SPR participants completed the 6MWT because the center had more space.
Measured: Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201715 Nov 2020

First posted2 Jan 2017 (estimated)
Study start1 Apr 2017
Primary completion15 Nov 2020
Study completion15 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COPD ExacerbationStudies of the same condition, open and under way.
More trials run by Northwell HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03007485
Sponsor's protocol ID: AD-1511-33066
Status last verified: Dec 2021
First submitted: 21 Dec 2016
Last updated: 10 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34495549
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.
PubMed 32012039

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03007485
Acronym / sponsor ID: AD-1511-33066
Conditions: COPD Exacerbation
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 1 Apr 2017 (actual)
Primary completion: 15 Nov 2020 (actual)
Study completion: 15 Nov 2020 (actual)
First posted: 2 Jan 2017 (estimated)
Results: Posted 10 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard of Care	No intervention	–Standard pulmonary rehabilitation
Intervention	Experimental	Other: Telehealth Pulmonary RehabilitationTelehealth delivered pulmonary rehabilitation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telehealth Pulmonary RehabilitationExercise 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.	Other	Intervention

Primary outcome

Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge
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). 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.

3 secondary outcomes

Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks
Time frame: 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
Time frame: 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
Time frame: Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)

Results and safety

Results posted to the registry on 10 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	98	28
Telehealth-delivered Pulmonary Rehabilitation	111	57

Primary outcome: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge

Time frame: 6 months post-discharge from hospitalization following COPD exacerbation. Number (95% Confidence Interval). Unit: Hospitalizations/death

Measure	Intention to Treat (ITT) n = 209	Medically Cleared n = 138	Bike n = 85
Unadjusted	1.34 (0.69 to 2.59)	1.06 (0.43 to 2.58)	0.88 (0.29 to 2.68)
Adjusted (race, hospital)	1.35 (0.69 to 2.66)	1.09 (0.43 to 2.73)	0.86 (0.27 to 2.72)

Intention to Treat (ITT) vs Medically Cleared vs Bike: Odds Ratio (OR): 1.0, p <.05, t-test, 2 sided

Population analysed: TelePR and SPR arms were combined as pre-specified in the study protocol and explained below: The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge. Logistic regression was used to compare the primary outcome in terms of the OR of event rates between arms, in 2 sets of models: * 1: Treatment arm only with no other covariates added to the model * 2: Treatment arm, adjusted for race and clinical site (stratification variables)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events was collected during the duration of the PR program - Day 1 to 8-weeks (completion of PR). The duration of time over which both, All-cause mortality and serious and other (non-serious) adverse events were assessed during Day 1 to 8 weeks (during PR) and until 6 months after enrollment into PR.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	3 of 98 (3.1%)	3 of 98 (3.1%)	2 of 98
Telehealth-delivered Pulmonary Rehabilitation	3 of 111 (2.7%)	13 of 111 (11.7%)	3 of 111

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34495549Poot 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.
Derived from this study: PubMed 32012039Pekmezaris 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.
Individual participant dataSharing planned: No

Related trials for COPD Exacerbation

Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
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Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
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Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Negin Hajizadeh, MD, MPH principal investigator

Hofstra Northwell School of Medicine, Northwell Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth Pulmonary Rehabilitation in people with COPD Exacerbation, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (time frame: 6 months post-discharge from hospitalization following COPD exacerbation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03007485, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.