Trial Outcomes & Findings for Telehealth Pulmonary Rehabilitation for Hispanic and African-American Patients Admitted With Exacerbation of COPD (NCT NCT03007485)

Last Updated: 2022-03-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

266 participants

Primary outcome timeframe

6 months post-discharge from hospitalization following COPD exacerbation

Results posted on

2022-03-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Standard of Care Standard pulmonary rehabilitation	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.
Overall Study STARTED	98	111
Overall Study COMPLETED	28	57
Overall Study NOT COMPLETED	70	54

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=98 Participants Standard pulmonary rehabilitation	Intervention n=111 Participants 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.	Total n=209 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=39 Participants	48 Participants n=41 Participants	91 Participants n=35 Participants
Age, Categorical >=65 years	55 Participants n=39 Participants	63 Participants n=41 Participants	118 Participants n=35 Participants
Age, Continuous	65.96 years STANDARD_DEVIATION 10.68 • n=39 Participants	66.89 years STANDARD_DEVIATION 10.80 • n=41 Participants	66.42 years STANDARD_DEVIATION 10.70 • n=35 Participants
Sex: Female, Male Female	57 Participants n=39 Participants	67 Participants n=41 Participants	124 Participants n=35 Participants
Sex: Female, Male Male	41 Participants n=39 Participants	44 Participants n=41 Participants	85 Participants n=35 Participants
Race/Ethnicity, Customized Hispanic	41 Participants n=39 Participants	48 Participants n=41 Participants	89 Participants n=35 Participants
Race/Ethnicity, Customized African-American	57 Participants n=39 Participants	63 Participants n=41 Participants	120 Participants n=35 Participants
Region of Enrollment United States	98 participants n=39 Participants	111 participants n=41 Participants	209 participants n=35 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Intention to Treat (ITT) n=209 Participants ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants	Medically Cleared n=138 Participants Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab.	Bike n=85 Participants Participants that agreed to participate, received medical clearance, and sat on the bike at least once.
Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge Unadjusted	1.34 Hospitalizations/death Interval 0.69 to 2.59	1.06 Hospitalizations/death Interval 0.43 to 2.58	0.88 Hospitalizations/death Interval 0.29 to 2.68
Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge Adjusted (race, hospital)	1.35 Hospitalizations/death Interval 0.69 to 2.66	1.09 Hospitalizations/death Interval 0.43 to 2.73	0.86 Hospitalizations/death Interval 0.27 to 2.72

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intention to Treat (ITT) n=37 Participants ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants	Medically Cleared Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab.	Bike Participants that agreed to participate, received medical clearance, and sat on the bike at least once.
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	—	—
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	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intention to Treat (ITT) n=37 Participants ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants	Medically Cleared n=62 Participants Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab.	Bike Participants that agreed to participate, received medical clearance, and sat on the bike at least once.
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 4.20	8.60 score on a scale Standard Deviation 4.28	—
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	8.29 score on a scale Standard Deviation 4.32	—
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	11.77 score on a scale Standard Deviation 4.95	—
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	10.43 score on a scale Standard Deviation 4.53	—
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	11.38 score on a scale Standard Deviation 4.90	—
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	10.92 score on a scale Standard Deviation 4.54	—
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	2.28 score on a scale Standard Deviation 1.14	—
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	22.37 score on a scale Standard Deviation 8.35	—
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	19.91 score on a scale Standard Deviation 7.94	—
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	21.12 score on a scale Standard Deviation 9.55	—
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 7.70	23.00 score on a scale Standard Deviation 8.26	—
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	2.46 score on a scale Standard Deviation 1.16	—
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	2.15 score on a scale Standard Deviation 1.30	—
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	2.42 score on a scale Standard Deviation 1.20	—
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	8.35 score on a scale Standard Deviation 4.21	—
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	7.97 score on a scale Standard Deviation 4.48	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intention to Treat (ITT) n=62 Participants ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants	Medically Cleared Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab.	Bike Participants that agreed to participate, received medical clearance, and sat on the bike at least once.
Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps Day 1	43.87 Steps Standard Deviation 17.42	—	—
Functional Capacity Before and After Pulmonary Rehabilitation (2-minute Step Test (TelePR) Tested in Steps 8 weeks	51.12 Steps Standard Deviation 23.46	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks post-discharge from hospitalization following COPD exacerbation

Population: The denominator here is all patients who received a referral to PR.

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.

Outcome measures

Outcome measures
Measure	Intention to Treat (ITT) n=98 Participants ITT: Total number of participants: 209 TelePR: 111 participants SPR: 98 participants	Medically Cleared n=111 Participants Participants that were medically cleared by their pulmonologist and cardiologist (if needed) to participate in pulmonary rehab.	Bike Participants that agreed to participate, received medical clearance, and sat on the bike at least once.
Measure of Patients' Uptake of PR i.e., Number of Referred Patients Who Participated in at Least One PR Session	37 Participants	62 Participants	—

Adverse Events

Standard of Care

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Telehealth-delivered Pulmonary Rehabilitation

Serious events: 3 serious events

Other events: 13 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care n=98 participants at risk Standard pulmonary rehabilitation	Telehealth-delivered Pulmonary Rehabilitation n=111 participants at risk 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.
Cardiac disorders Serious Adverse Event	1.0% 1/98 • 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.	2.7% 3/111 • 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.
Respiratory, thoracic and mediastinal disorders Serious Adverse Event	2.0% 2/98 • 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.	0.00% 0/111 • 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.

Other adverse events

Other adverse events
Measure	Standard of Care n=98 participants at risk Standard pulmonary rehabilitation	Telehealth-delivered Pulmonary Rehabilitation n=111 participants at risk 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.
Cardiac disorders Other (Not Including Serious) Adverse Events	2.0% 2/98 • 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.	8.1% 9/111 • 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.
Eye disorders Other (Not Including Serious) Adverse Events	1.0% 1/98 • 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.	0.90% 1/111 • 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.
Musculoskeletal and connective tissue disorders Other (Not Including Serious) Adervse Events	0.00% 0/98 • 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.	1.8% 2/111 • 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.
Metabolism and nutrition disorders Other (Not Including Serious) Adverse Events	0.00% 0/98 • 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.	0.90% 1/111 • 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.

Additional Information

Dr. Negin Hajizadeh

Northwell Health

Phone: 516-600-1401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place