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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard pulmonary rehabilitation | |
| Intervention | Experimental | Telehealth delivered pulmonary rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session | 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. | 8 weeks post-discharge from hospitalization following COPD exacerbation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Negin Hajizadeh, MD, MPH | Hofstra Northwell School of Medicine, Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34495549 | Derived | 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. | |
| 32012039 | 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. |
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In total 266 participants signed the informed consent and were randomized (131 to the TelePR arm and 135 to the SPR arm). Of the 131 randomized to TelePR, 20 were subsequently excluded after randomization because they no longer met inclusion criteria. Of the 135 randomized to SPR, 37 were excluded after randomization because they also no longer met inclusion criteria. Therefore, in total 209 participants were randomized and were included in the intention to treat analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard pulmonary rehabilitation |
| FG001 | Telehealth-delivered Pulmonary Rehabilitation | Telehealth delivered pulmonary rehabilitation- Intervention 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Standard pulmonary rehabilitation |
| BG001 | Intervention | Telehealth delivered pulmonary rehabilitation 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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:
| Posted | Number | 95% Confidence Interval | Hospitalizations/death | 6 months post-discharge from hospitalization following COPD exacerbation |
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.
Hospital readmission/death were monitored/assess within 6 month of discharged which includes the duration of PR 8 weeks. Adverse events were only collected during the duration of the PR program (Day1 to 8 weeks). Deaths were not assessed for a different duration of time than Serious and Other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Standard pulmonary rehabilitation | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Event | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other (Not Including Serious) Adverse Events | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Negin Hajizadeh | Northwell Health | 516-600-1401 | Nhajizadeh@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2019 | Feb 11, 2021 | Prot_SAP_000.pdf |
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| 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. | 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. | Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Intention to Treat (ITT) | ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants |
| OG001 | Medically Cleared | Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab. |
| OG002 | Bike | Participants that agreed to participate, received medical clearance, and sat on the bike at least once. |
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| Secondary | 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. | Data in SPR arm reported in Outcome Measures in meters due to space. | Posted | Mean | Standard Deviation | Meters | Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation |
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| Secondary | 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. | Data in TelePR arm reported in Outcome Measures in steps due to space limitation. | Posted | Mean | Standard Deviation | Steps | Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks) |
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| Other Pre-specified | Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session | 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. | The denominator here is all patients who received a referral to PR. | Posted | Count of Participants | Participants | 8 weeks post-discharge from hospitalization following COPD exacerbation |
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| 98 |
| 3 |
| 98 |
| 3 |
| 98 |
| EG001 | Telehealth-delivered Pulmonary Rehabilitation | Telehealth delivered pulmonary rehabilitation 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. | 3 | 111 | 3 | 111 | 13 | 111 |
| Serious Adverse Event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other (Not Including Serious) Adverse Events | Eye disorders | Systematic Assessment |
|
| Other (Not Including Serious) Adervse Events | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other (Not Including Serious) Adverse Events | Metabolism and nutrition disorders | Systematic Assessment |
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| CAT 6 months |
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| CAT 12 months |
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| Modified Medical Research Council Scale (MMRC) Day 1 |
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| MMRC 8-weeks |
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| MMRC 6 months |
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| MMRC 12 months |
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| PROMIS: Depression Day 1 |
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| PROMIS: Depression 8-weeks |
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| PROMIS: Depression 6 months |
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| PROMIS: Depression 12 months |
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| PROMIS: Fatigue |
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| PROMIS: Fatigue 8-weeks |
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| PROMIS: Fatigue 6 months |
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| PROMIS: Fatigue 12 months |
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