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| ID | Type | Description | Link |
|---|---|---|---|
| R61HL142933 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Experimental | Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching. |
|
| Control- Choice | No Intervention | This arm was the choice of Pulmonary Rehabilitation at a facility or Home-based pulmonary rehabilitation program with health coaching. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention- Home-based Pulmonary Rehabilitation | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Pulmonary Rehabilitation (PR) | The number of subjects who completed PR through 3 months | baseline; 3 months |
| 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 | baseline; 3 months |
| 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. | baseline; 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 3 months |
| Number of Subjects Who Had a Hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
- Inability to walk (orthopedic-neurologic problems or confined to bed)
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P Benzo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Partners Institute | Bloomington | Minnesota | 55425 | United States | ||
| Mayo Clinic in Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33511633 | Derived | Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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296 participants were consented to the study. 2 participants were withdrawn from the study before assignment to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Pulmonary Rehabilitation (PR) | The number of subjects who completed PR through 3 months | Posted | Count of Participants | Participants | baseline; 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Benzo, M.D. | Mayo Clinic | 480-301-8244 | benzo.roberto@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2023 | Aug 27, 2025 | Prot_SAP_000.pdf |
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|
The number of subjects who had at least one hospitalization from baseline to 3 months.
| baseline; 3 months |
| 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. | baseline; 3 months |
| Change in Daily Step Count | Participants wore an Actigraph Activity Monitor for one week to measure daily steps. | baseline; 3 months |
| 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. | Baseline; 3 months |
| 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. | baseline; 3 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Disease Progression |
|
| Complicating Disease |
|
| Lost Contact |
|
| Ineligible |
|
| Refused Further Study Participation |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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.
|
|
| 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 | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | baseline; 3 months |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline; 3 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline to 3 months |
|
|
|
| Secondary | Number of Subjects Who Had a Hospitalization | The number of subjects who had at least one hospitalization from baseline to 3 months. | Posted | Count of Participants | Participants | baseline; 3 months |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline; 3 months |
|
|
|
| Secondary | Change in Daily Step Count | Participants wore an Actigraph Activity Monitor for one week to measure daily steps. | Posted | Mean | 95% Confidence Interval | steps per day | baseline; 3 months |
|
|
|
| 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. | 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) | Posted | Mean | 95% Confidence Interval | minutes per day | Baseline; 3 months |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline; 3 months |
|
|
|
| 8 |
| 147 |
| 2 |
| 147 |
| 0 |
| 147 |
| EG001 | 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. | 9 | 147 | 1 | 147 | 1 | 147 |
| Congestive Heart Failure Exacerbation | Cardiac disorders | Systematic Assessment |
|
| Back Fractures | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Self Care |
|
|
| Usual Activities |
|
|
| Pain/Discomfort |
|
|
| Anxiety/Depression |
|
|
| Health Today (VAS Score) |
|
|