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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

296 participants

Primary outcome timeframe

baseline; 3 months

Results posted on

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296 participants were consented to the study. 2 participants were withdrawn from the study before assignment to groups.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

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

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

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 months

The number of subjects who completed PR through 3 months

Outcome measures

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 months

Population: 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

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 months

Population: 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

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 months

The number of subjects who had at least one Emergency Department visit from baseline to 3 months.

Outcome measures

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 months

The number of subjects who had at least one hospitalization from baseline to 3 months.

Outcome measures

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 months

Measured 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

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 months

Participants wore an Actigraph Activity Monitor for one week to measure daily steps.

Outcome measures

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 months

Population: 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

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 months

The 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

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

Serious events: 2 serious events
Other events: 0 other events
Deaths: 8 deaths

Control- Choice

Serious events: 1 serious events
Other events: 1 other events
Deaths: 9 deaths

Serious adverse events

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

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

Roberto Benzo, M.D.

Mayo Clinic

Phone: 480-301-8244

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place