COPD Exacerbation
Conditions
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.
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.
Interventions
OTHERTelehealth 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.
Sponsors
Patient-Centered Outcomes Research Institute
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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 | 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. |
| 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) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Standard pulmonary rehabilitation | 98 |
| 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. | 111 |
| Total | 209 |
Baseline characteristics
| Characteristic | Standard of Care | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 63 Participants | 118 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 48 Participants | 91 Participants |
| Age, Continuous | 65.96 years STANDARD_DEVIATION 10.68 | 66.89 years STANDARD_DEVIATION 10.8 | 66.42 years STANDARD_DEVIATION 10.7 |
| Race/Ethnicity, Customized African-American | 57 Participants | 63 Participants | 120 Participants |
| Race/Ethnicity, Customized Hispanic | 41 Participants | 48 Participants | 89 Participants |
| Region of Enrollment United States | 98 participants | 111 participants | 209 participants |
| Sex: Female, Male Female | 57 Participants | 67 Participants | 124 Participants |
| Sex: Female, Male Male | 41 Participants | 44 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 98 | 3 / 111 |
| other Total, other adverse events | 3 / 98 | 13 / 111 |
| serious Total, serious adverse events | 3 / 98 | 3 / 111 |
Outcome results
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.
Time frame: 6 months post-discharge from hospitalization following COPD exacerbation
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intention to Treat (ITT) | Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | Unadjusted | 1.34 Hospitalizations/death |
| Intention to Treat (ITT) | Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | Adjusted (race, hospital) | 1.35 Hospitalizations/death |
| Medically Cleared | Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | Unadjusted | 1.06 Hospitalizations/death |
| Medically Cleared | Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | Adjusted (race, hospital) | 1.09 Hospitalizations/death |
| Bike | Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | Unadjusted | 0.88 Hospitalizations/death |
| Bike | Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | Adjusted (race, hospital) | 0.86 Hospitalizations/death |
Comparison: Sample size and power calculation was a composite of COPD-related hospital readmissions or death within 6 months of discharge. First level of analysis was the ITT, which included all the patients randomly assigned to an arm at the beginning of the study (excluding those who were found to not meet inclusion criteria for referral). The second included all the patients medically cleared and third included all the patients who were medically cleared and who had participated in at least 1 PR session.p-value: <0.05t-test, 2 sided
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.
Time frame: Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | COPD Assessment Test (CAT) Day 1 | 20.89 score on a scale | Standard Deviation 8.53 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | CAT 8-weeks | 20.18 score on a scale | Standard Deviation 8.41 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | CAT 6 months | 23.07 score on a scale | Standard Deviation 7.54 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | CAT 12 months | 20.09 score on a scale | Standard Deviation 7.7 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | Modified Medical Research Council Scale (MMRC) Day 1 | 2.24 score on a scale | Standard Deviation 1.04 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | MMRC 8-weeks | 2.24 score on a scale | Standard Deviation 1.28 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | MMRC 6 months | 2.48 score on a scale | Standard Deviation 1.18 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | MMRC 12 months | 2.45 score on a scale | Standard Deviation 0.91 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression Day 1 | 7.38 score on a scale | Standard Deviation 4.24 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression 8-weeks | 7.85 score on a scale | Standard Deviation 3.78 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression 6 months | 9.25 score on a scale | Standard Deviation 4.2 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression 12 months | 8.47 score on a scale | Standard Deviation 4.25 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue | 9.70 score on a scale | Standard Deviation 4.47 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue 8-weeks | 10.88 score on a scale | Standard Deviation 4.21 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue 6 months | 11.43 score on a scale | Standard Deviation 3.99 |
| Intention to Treat (ITT) | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue 12 months | 11.50 score on a scale | Standard Deviation 4.68 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue 12 months | 10.92 score on a scale | Standard Deviation 4.54 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | COPD Assessment Test (CAT) Day 1 | 22.37 score on a scale | Standard Deviation 8.35 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression Day 1 | 8.35 score on a scale | Standard Deviation 4.21 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | CAT 8-weeks | 19.91 score on a scale | Standard Deviation 7.94 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue | 11.77 score on a scale | Standard Deviation 4.95 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | CAT 6 months | 21.12 score on a scale | Standard Deviation 9.55 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression 8-weeks | 7.97 score on a scale | Standard Deviation 4.48 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | CAT 12 months | 23.00 score on a scale | Standard Deviation 8.26 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue 6 months | 11.38 score on a scale | Standard Deviation 4.9 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | Modified Medical Research Council Scale (MMRC) Day 1 | 2.46 score on a scale | Standard Deviation 1.16 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression 6 months | 8.60 score on a scale | Standard Deviation 4.28 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | MMRC 8-weeks | 2.28 score on a scale | Standard Deviation 1.14 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Fatigue 8-weeks | 10.43 score on a scale | Standard Deviation 4.53 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | MMRC 6 months | 2.15 score on a scale | Standard Deviation 1.3 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | PROMIS: Depression 12 months | 8.29 score on a scale | Standard Deviation 4.32 |
| Medically Cleared | Change in Self-reported Quality of Life: Longitudinal Outcomes. Surveys Administered Over the Entire Follow up Period Directly Before and After the PR Program | MMRC 12 months | 2.42 score on a scale | Standard Deviation 1.2 |
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.
Time frame: Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)
Population: Data in TelePR arm reported in Outcome Measures in steps due to space limitation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intention to Treat (ITT) | Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps | Day 1 | 43.87 Steps | Standard Deviation 17.42 |
| Intention to Treat (ITT) | Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps | 8 weeks | 51.12 Steps | Standard Deviation 23.46 |
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.
Time frame: Prior to beginning PR (Day 1) and after completion of PR ( 8-weeks)
Population: Data in SPR arm reported in Outcome Measures in meters due to space.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intention to Treat (ITT) | Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks | 8 weeks | 275.29 Meters | Standard Deviation 137.85 |
| Intention to Treat (ITT) | Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks | Day 1 | 261.92 Meters | Standard Deviation 125.85 |
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.
Time frame: 8 weeks post-discharge from hospitalization following COPD exacerbation
Population: The denominator here is all patients who received a referral to PR.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intention to Treat (ITT) | Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session | 37 Participants |
| Medically Cleared | Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session | 62 Participants |