Trial Outcomes & Findings for Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2) (NCT NCT04521608)
NCT ID: NCT04521608
Last Updated: 2025-11-21
Results Overview
The number of subjects who completed PR through 3 months
COMPLETED
NA
296 participants
baseline; 3 months
2025-11-21
Participant Flow
296 participants were consented to the study. 2 participants were withdrawn from the study before assignment to groups.
Participant milestones
| Measure |
Intervention- Home Pulmonary Rehabilitation
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
147
|
|
Overall Study
COMPLETED
|
66
|
73
|
|
Overall Study
NOT COMPLETED
|
81
|
74
|
Reasons for withdrawal
| Measure |
Intervention- Home Pulmonary Rehabilitation
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Overall Study
Death
|
8
|
9
|
|
Overall Study
Withdrawal by Subject
|
25
|
18
|
|
Overall Study
Disease Progression
|
3
|
10
|
|
Overall Study
Complicating Disease
|
6
|
3
|
|
Overall Study
Lost Contact
|
25
|
27
|
|
Overall Study
Ineligible
|
1
|
0
|
|
Overall Study
Refused Further Study Participation
|
13
|
7
|
Baseline Characteristics
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)
Baseline characteristics by cohort
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=147 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=147 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Age, Continuous
|
70.52 years
STANDARD_DEVIATION 8.99 • n=39 Participants
|
70.39 years
STANDARD_DEVIATION 8.56 • n=29 Participants
|
70.45 years
STANDARD_DEVIATION 8.76 • n=60 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=39 Participants
|
77 Participants
n=29 Participants
|
155 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=39 Participants
|
70 Participants
n=29 Participants
|
139 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=39 Participants
|
138 Participants
n=29 Participants
|
280 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
7 Participants
n=29 Participants
|
12 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=39 Participants
|
4 Participants
n=29 Participants
|
11 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=39 Participants
|
141 Participants
n=29 Participants
|
279 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
1 Participants
n=29 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=39 Participants
|
147 participants
n=29 Participants
|
294 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: baseline; 3 monthsThe number of subjects who completed PR through 3 months
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=147 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=147 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Adherence to Pulmonary Rehabilitation (PR)
|
82 Participants
|
95 Participants
|
PRIMARY outcome
Timeframe: baseline; 3 monthsPopulation: The results are presented as the difference between baseline and month 3 (end of the intervention). For the interpretation of CRQ results: a difference\>0.5 is considered clinically meaningful
The Chronic Respiratory Questionnaire (CRQ) is a validated tool that is completed by participants at baseline and 3 months, measuring health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. We reported the difference between baseline and 3 months on the CRQ emotional summary scores (comprised of the summation of the mastery and emotional domains of CRQ divided by 2) and the physical summary score (comprised of the summation of the dyspnea and fatigue domains of the CRQ divided by 2). Summary scores as well as the original domains , all have a range of 1 to 7 points, with a higher number being a better health-related quality of life. 0.5 points is the minimal clinically important difference for this tool. Then, for the interpretation of CRQ results: a difference\>0.5 is considered clinically meaningful
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=80 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=91 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).
CRQ Physical Summary Score
|
0.37 score on a scale
Interval 0.18 to 0.56
|
0.8 score on a scale
Interval 0.59 to 1.01
|
|
Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).
CRQ Emotional Summary Score
|
0.46 score on a scale
Interval 0.24 to 0.69
|
0.6 score on a scale
Interval 0.4 to 0.8
|
PRIMARY outcome
Timeframe: baseline; 3 monthsPopulation: 1 subject in the intervention arm was not included in the analysis for the health today (VAS score) score of the questionnaire and 1 subject in the choice arm was not included in the analysis for the pain/discomfort score of the questionnaire as both subjects inadvertently skipped those sections of the questionnaire.
The EuroQol (EQ-5D) is a 5-item questionnaire that assesses health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It also includes a Visual Analogue Scale (VAS) for self-related heath. Each dimension uses a 5-level Likert scale (1 = no problems, 5 = extreme problems), ensuring nuanced data collection. The VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health). Scores are calculated for each dimension with total scores ranging from 1 (no problems) to 5 (extreme problems), with higher scores indicating a worse outcome. The score from the VAS portion of the questionnaire ranges from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating a better outcome.
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=80 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=91 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Change in EuroQol (EQ-5D) Score
Mobility
|
-0.28 score on a scale
Interval -0.49 to -0.06
|
-0.23 score on a scale
Interval -0.42 to -0.04
|
|
Change in EuroQol (EQ-5D) Score
Self Care
|
-0.22 score on a scale
Interval -0.43 to -0.02
|
-0.08 score on a scale
Interval -0.19 to 0.04
|
|
Change in EuroQol (EQ-5D) Score
Usual Activities
|
-0.25 score on a scale
Interval -0.44 to -0.06
|
-0.16 score on a scale
Interval -0.36 to 0.03
|
|
Change in EuroQol (EQ-5D) Score
Pain/Discomfort
|
0.06 score on a scale
Interval -0.11 to 0.24
|
-0.24 score on a scale
Interval -0.4 to -0.09
|
|
Change in EuroQol (EQ-5D) Score
Anxiety/Depression
|
-0.09 score on a scale
Interval -0.26 to 0.09
|
-0.21 score on a scale
Interval -0.39 to -0.03
|
|
Change in EuroQol (EQ-5D) Score
Health Today (VAS Score)
|
3.27 score on a scale
Interval -1.56 to 8.1
|
8.16 score on a scale
Interval 4.15 to 12.18
|
SECONDARY outcome
Timeframe: baseline to 3 monthsThe number of subjects who had at least one Emergency Department visit from baseline to 3 months.
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=82 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=95 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Number of Subjects Who Visited the Emergency Department
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: baseline; 3 monthsThe number of subjects who had at least one hospitalization from baseline to 3 months.
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=82 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=95 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Number of Subjects Who Had a Hospitalization
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: baseline; 3 monthsMeasured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome.
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=80 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=91 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Change in Self-Management Ability Scale
|
1.9 score on a scale
Interval -0.22 to 4.01
|
3.34 score on a scale
Interval 1.72 to 4.97
|
SECONDARY outcome
Timeframe: baseline; 3 monthsParticipants wore an Actigraph Activity Monitor for one week to measure daily steps.
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=76 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=81 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Change in Daily Step Count
|
398.37 steps per day
Interval -87.07 to 883.82
|
362.9 steps per day
Interval -140.96 to 866.77
|
SECONDARY outcome
Timeframe: Baseline; 3 monthsPopulation: For the interpretation of activity: a negative number in sedentary time and a positive number for overall physical activity are the goals (no defined minimal important difference)
Participants wore an Actigraph Activity Monitor for one week to measure daily time spent doing sedentary (low energy expenditure) and non-sedentary (high energy expenditure) activities.
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=76 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=81 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Change in Daily Total Physical Activity and Sedentary Time
Average Daily Sedentary Time
|
3.39 minutes per day
Interval -35.16 to 41.94
|
-20.93 minutes per day
Interval -58.57 to 16.7
|
|
Change in Daily Total Physical Activity and Sedentary Time
Average Daily Non-Sedentary Time
|
1.14 minutes per day
Interval -28.39 to 30.66
|
9.34 minutes per day
Interval -16.82 to 35.51
|
SECONDARY outcome
Timeframe: baseline; 3 monthsThe Duke-UNC Functional Social Support Questionnaire is an 8-item questionnaire that measures the amount of social support and availability of help from family and friends. The answers range from 1 "Much less than I would like" to 5 " As much as I would like". The scores from all 8 questions are summed (maximum 40) and then divided by 8 to get an average score. The higher the average score, the greater the perceived social support.
Outcome measures
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=95 Participants
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=102 Participants
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score
|
-0.32 score on a scale
Interval -0.63 to 0.0
|
-0.2 score on a scale
Interval -0.47 to 0.07
|
Adverse Events
Intervention- Home Pulmonary Rehabilitation
Control- Choice
Serious adverse events
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=147 participants at risk
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=147 participants at risk
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.00%
0/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
0.68%
1/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
|
Cardiac disorders
Congestive Heart Failure Exacerbation
|
0.68%
1/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
0.00%
0/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
|
Injury, poisoning and procedural complications
Back Fractures
|
0.68%
1/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
0.00%
0/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
Other adverse events
| Measure |
Intervention- Home Pulmonary Rehabilitation
n=147 participants at risk
Participants enrolled in the intervention arm were offered a Home-based pulmonary rehabilitation program with health coaching.
Intervention- Home-based Pulmonary Rehabilitation: Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that allowed patients to complete PR at home. The program involved upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
|
Control- Choice
n=147 participants at risk
This arm received the standard of care which included the choice of PR at a facility or through telehealth. Center based PR involved attending a medical center gym where they could do exercises and receive disease specific education. Telehealth PR was delivered virtually through the computer or telephone.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.00%
0/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
0.68%
1/147 • Adverse events were collected from the time of informed consent through study completion, approximately 1 year.
Adverse events were collected through follow up telephone calls with the subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place