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Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04521608
Enrollment
296
Registered
2020-08-20
Start date
2020-11-30
Completion date
2024-09-19
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Brief summary

This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.

Detailed description

Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation. The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study. Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or home-based PR.

Interventions

Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* COPD related hospitalization and eligible for PR * Age 40+ * Confidence (score \> 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

Exclusion criteria

\- Inability to walk (orthopedic-neurologic problems or confined to bed)

Design outcomes

Primary

MeasureTime frameDescription
Adherence to Pulmonary Rehabilitation (PR)baseline; 3 monthsThe number of subjects who completed PR through 3 months
Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).baseline; 3 monthsThe 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
Change in EuroQol (EQ-5D) Scorebaseline; 3 monthsThe 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.

Secondary

MeasureTime frameDescription
Change in Daily Step Countbaseline; 3 monthsParticipants wore an Actigraph Activity Monitor for one week to measure daily steps.
Number of Subjects Who Visited the Emergency Departmentbaseline to 3 monthsThe number of subjects who had at least one Emergency Department visit from baseline to 3 months.
Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Scorebaseline; 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.
Change in Daily Total Physical Activity and Sedentary TimeBaseline; 3 monthsParticipants 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.
Number of Subjects Who Had a Hospitalizationbaseline; 3 monthsThe number of subjects who had at least one hospitalization from baseline to 3 months.
Change in Self-Management Ability Scalebaseline; 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.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
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).
147
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.
147
Total294

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyComplicating Disease63
Overall StudyDeath89
Overall StudyDisease Progression310
Overall StudyIneligible10
Overall StudyLost Contact2527
Overall StudyRefused Further Study Participation137
Overall StudyWithdrawal by Subject2518

Baseline characteristics

CharacteristicIntervention- Home Pulmonary RehabilitationTotalControl- Choice
Age, Continuous70.52 years
STANDARD_DEVIATION 8.99
70.45 years
STANDARD_DEVIATION 8.76
70.39 years
STANDARD_DEVIATION 8.56
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
142 Participants280 Participants138 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants12 Participants7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants11 Participants4 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
138 Participants279 Participants141 Participants
Region of Enrollment
United States
147 participants294 participants147 participants
Sex: Female, Male
Female
78 Participants155 Participants77 Participants
Sex: Female, Male
Male
69 Participants139 Participants70 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
8 / 1479 / 147
other
Total, other adverse events
0 / 1471 / 147
serious
Total, serious adverse events
2 / 1471 / 147

Outcome results

Primary

Adherence to Pulmonary Rehabilitation (PR)

The number of subjects who completed PR through 3 months

Time frame: baseline; 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention- Home Pulmonary RehabilitationAdherence to Pulmonary Rehabilitation (PR)82 Participants
Control- ChoiceAdherence to Pulmonary Rehabilitation (PR)95 Participants
Primary

Change in EuroQol (EQ-5D) Score

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)
Intervention- Home Pulmonary RehabilitationChange in EuroQol (EQ-5D) ScoreUsual Activities-0.25 score on a scale
Intervention- Home Pulmonary RehabilitationChange in EuroQol (EQ-5D) ScoreHealth Today (VAS Score)3.27 score on a scale
Intervention- Home Pulmonary RehabilitationChange in EuroQol (EQ-5D) ScorePain/Discomfort0.06 score on a scale
Intervention- Home Pulmonary RehabilitationChange in EuroQol (EQ-5D) ScoreSelf Care-0.22 score on a scale
Intervention- Home Pulmonary RehabilitationChange in EuroQol (EQ-5D) ScoreAnxiety/Depression-0.09 score on a scale
Intervention- Home Pulmonary RehabilitationChange in EuroQol (EQ-5D) ScoreMobility-0.28 score on a scale
Control- ChoiceChange in EuroQol (EQ-5D) ScoreHealth Today (VAS Score)8.16 score on a scale
Control- ChoiceChange in EuroQol (EQ-5D) ScoreMobility-0.23 score on a scale
Control- ChoiceChange in EuroQol (EQ-5D) ScoreSelf Care-0.08 score on a scale
Control- ChoiceChange in EuroQol (EQ-5D) ScoreUsual Activities-0.16 score on a scale
Control- ChoiceChange in EuroQol (EQ-5D) ScorePain/Discomfort-0.24 score on a scale
Control- ChoiceChange in EuroQol (EQ-5D) ScoreAnxiety/Depression-0.21 score on a scale
Primary

Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).

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

Time frame: 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

ArmMeasureGroupValue (MEAN)
Intervention- Home Pulmonary RehabilitationChange in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).CRQ Physical Summary Score0.37 score on a scale
Intervention- Home Pulmonary RehabilitationChange in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).CRQ Emotional Summary Score0.46 score on a scale
Control- ChoiceChange in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).CRQ Physical Summary Score0.8 score on a scale
Control- ChoiceChange in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ).CRQ Emotional Summary Score0.6 score on a scale
Secondary

Change in Daily Step Count

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

Time frame: baseline; 3 months

ArmMeasureValue (MEAN)
Intervention- Home Pulmonary RehabilitationChange in Daily Step Count398.37 steps per day
Control- ChoiceChange in Daily Step Count362.9 steps per day
Secondary

Change in Daily Total Physical Activity and Sedentary Time

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.

Time frame: 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)

ArmMeasureGroupValue (MEAN)
Intervention- Home Pulmonary RehabilitationChange in Daily Total Physical Activity and Sedentary TimeAverage Daily Sedentary Time3.39 minutes per day
Intervention- Home Pulmonary RehabilitationChange in Daily Total Physical Activity and Sedentary TimeAverage Daily Non-Sedentary Time1.14 minutes per day
Control- ChoiceChange in Daily Total Physical Activity and Sedentary TimeAverage Daily Sedentary Time-20.93 minutes per day
Control- ChoiceChange in Daily Total Physical Activity and Sedentary TimeAverage Daily Non-Sedentary Time9.34 minutes per day
Secondary

Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score

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.

Time frame: baseline; 3 months

ArmMeasureValue (MEAN)
Intervention- Home Pulmonary RehabilitationChange in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score-0.32 score on a scale
Control- ChoiceChange in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score-0.2 score on a scale
Secondary

Change in Self-Management Ability Scale

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.

Time frame: baseline; 3 months

ArmMeasureValue (MEAN)
Intervention- Home Pulmonary RehabilitationChange in Self-Management Ability Scale1.9 score on a scale
Control- ChoiceChange in Self-Management Ability Scale3.34 score on a scale
Secondary

Number of Subjects Who Had a Hospitalization

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

Time frame: baseline; 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention- Home Pulmonary RehabilitationNumber of Subjects Who Had a Hospitalization23 Participants
Control- ChoiceNumber of Subjects Who Had a Hospitalization21 Participants
Secondary

Number of Subjects Who Visited the Emergency Department

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

Time frame: baseline to 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention- Home Pulmonary RehabilitationNumber of Subjects Who Visited the Emergency Department18 Participants
Control- ChoiceNumber of Subjects Who Visited the Emergency Department24 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026