COPD Exacerbation
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Pulmonary Rehabilitation (PR) | baseline; 3 months | The 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 months | 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 |
| Change in EuroQol (EQ-5D) Score | baseline; 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Step Count | baseline; 3 months | Participants wore an Actigraph Activity Monitor for one week to measure daily steps. |
| Number of Subjects Who Visited the Emergency Department | baseline to 3 months | The 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) Score | 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. |
| Change in Daily Total Physical Activity and Sedentary Time | Baseline; 3 months | 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. |
| Number of Subjects Who Had a Hospitalization | baseline; 3 months | The number of subjects who had at least one hospitalization from baseline to 3 months. |
| Change in Self-Management Ability Scale | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Complicating Disease | 6 | 3 |
| Overall Study | Death | 8 | 9 |
| Overall Study | Disease Progression | 3 | 10 |
| Overall Study | Ineligible | 1 | 0 |
| Overall Study | Lost Contact | 25 | 27 |
| Overall Study | Refused Further Study Participation | 13 | 7 |
| Overall Study | Withdrawal by Subject | 25 | 18 |
Baseline characteristics
| Characteristic | Intervention- Home Pulmonary Rehabilitation | Total | Control- Choice |
|---|---|---|---|
| Age, Continuous | 70.52 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 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants | 280 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 138 Participants | 279 Participants | 141 Participants |
| Region of Enrollment United States | 147 participants | 294 participants | 147 participants |
| Sex: Female, Male Female | 78 Participants | 155 Participants | 77 Participants |
| Sex: Female, Male Male | 69 Participants | 139 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 147 | 9 / 147 |
| other Total, other adverse events | 0 / 147 | 1 / 147 |
| serious Total, serious adverse events | 2 / 147 | 1 / 147 |
Outcome results
Adherence to Pulmonary Rehabilitation (PR)
The number of subjects who completed PR through 3 months
Time frame: baseline; 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Adherence to Pulmonary Rehabilitation (PR) | 82 Participants |
| Control- Choice | Adherence to Pulmonary Rehabilitation (PR) | 95 Participants |
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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in EuroQol (EQ-5D) Score | Usual Activities | -0.25 score on a scale |
| Intervention- Home Pulmonary Rehabilitation | Change in EuroQol (EQ-5D) Score | Health Today (VAS Score) | 3.27 score on a scale |
| Intervention- Home Pulmonary Rehabilitation | Change in EuroQol (EQ-5D) Score | Pain/Discomfort | 0.06 score on a scale |
| Intervention- Home Pulmonary Rehabilitation | Change in EuroQol (EQ-5D) Score | Self Care | -0.22 score on a scale |
| Intervention- Home Pulmonary Rehabilitation | Change in EuroQol (EQ-5D) Score | Anxiety/Depression | -0.09 score on a scale |
| Intervention- Home Pulmonary Rehabilitation | Change in EuroQol (EQ-5D) Score | Mobility | -0.28 score on a scale |
| Control- Choice | Change in EuroQol (EQ-5D) Score | Health Today (VAS Score) | 8.16 score on a scale |
| Control- Choice | Change in EuroQol (EQ-5D) Score | Mobility | -0.23 score on a scale |
| Control- Choice | Change in EuroQol (EQ-5D) Score | Self Care | -0.08 score on a scale |
| Control- Choice | Change in EuroQol (EQ-5D) Score | Usual Activities | -0.16 score on a scale |
| Control- Choice | Change in EuroQol (EQ-5D) Score | Pain/Discomfort | -0.24 score on a scale |
| Control- Choice | Change in EuroQol (EQ-5D) Score | Anxiety/Depression | -0.21 score on a scale |
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | 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 |
| Intervention- Home Pulmonary Rehabilitation | 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 |
| Control- Choice | Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ). | CRQ Physical Summary Score | 0.8 score on a scale |
| Control- Choice | Change in Health Related Quality of Life as Measured by the Chronic Respiratory Questionnaire (CRQ). | CRQ Emotional Summary Score | 0.6 score on a scale |
Change in Daily Step Count
Participants wore an Actigraph Activity Monitor for one week to measure daily steps.
Time frame: baseline; 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in Daily Step Count | 398.37 steps per day |
| Control- Choice | Change in Daily Step Count | 362.9 steps per day |
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in Daily Total Physical Activity and Sedentary Time | Average Daily Sedentary Time | 3.39 minutes per day |
| Intervention- Home Pulmonary Rehabilitation | Change in Daily Total Physical Activity and Sedentary Time | Average Daily Non-Sedentary Time | 1.14 minutes per day |
| Control- Choice | Change in Daily Total Physical Activity and Sedentary Time | Average Daily Sedentary Time | -20.93 minutes per day |
| Control- Choice | Change in Daily Total Physical Activity and Sedentary Time | Average Daily Non-Sedentary Time | 9.34 minutes per day |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score | -0.32 score on a scale |
| Control- Choice | Change in Duke-UNC Functional Social Support Questionnaire (FSSQ) Score | -0.2 score on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in Self-Management Ability Scale | 1.9 score on a scale |
| Control- Choice | Change in Self-Management Ability Scale | 3.34 score on a scale |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Number of Subjects Who Had a Hospitalization | 23 Participants |
| Control- Choice | Number of Subjects Who Had a Hospitalization | 21 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Number of Subjects Who Visited the Emergency Department | 18 Participants |
| Control- Choice | Number of Subjects Who Visited the Emergency Department | 24 Participants |