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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 pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause.
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. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective.
In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation.
10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Experimental | Participants will be offered a 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 One Balance Practice Routine | Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program | Baseline to 3 months |
| Adherence to Two Balance Practice Routine | Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program | Baseline to 3 months |
| Adherence to Daily Flexible Practice Routine | Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program | Baseline to 3 months |
| Completion of the Daily Self-assessment | Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary | The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Physical Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P Benzo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention- Home Pulmonary Rehabilitation | Participants will be 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 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention- Home Pulmonary Rehabilitation | Participants will be 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 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). |
| 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 One Balance Practice Routine | Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program | Posted | Number | percentage of participants | Baseline to 3 months |
|
Adverse events were collected from baseline to end of study for a total of approximately 3 months on all participants.
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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 | 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). Intervention- Home-based Pulmonary Rehabilitation: Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roberto Benzo | Mayo Clinic | (507) 284-0561 | 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 3, 2020 | Jun 17, 2020 | Prot_SAP_000.pdf |
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|
| Baseline, 3 months |
| Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary | The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best. | Baseline, 3 months |
| Daily Physical Activity | Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months | 3 months |
| Change in the Self-Management Ability Scale (SMAS) Total Score | Measured using the total score from the self-reported SMAS 30 item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. The SMAS30 has six areas, each with 5 questions. The minimum score is one and the max is 5. The mean is calculated for each section. A higher score indicates better self management. | Baseline, 3 months |
| Change in Patient Health Questionnaire (PHQ-2) | Measured using the self-reported PHQ-2 consisting of a 2 item questionnaire inquiring about the frequency of depressed mood over the past 2 weeks on a scale of 0 to 3, 0=Not at all, 1=several days, 2=more than half the days, 3=nearly everyday. The minimum score is zero and the highest score is 6. A score greater than 3 may indicate depression. | Baseline, 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Adherence to Two Balance Practice Routine | Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program | Posted | Number | percentage of participants | Baseline to 3 months |
|
|
|
| Primary | Adherence to Daily Flexible Practice Routine | Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program | Posted | Number | percentage of participants | Baseline to 3 months |
|
|
|
| Primary | Completion of the Daily Self-assessment | Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program | Posted | Number | percentage of participants | Baseline to 3 months |
|
|
|
| Secondary | Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary | The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Physical Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
|
| Secondary | Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary | The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
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|
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| Secondary | Daily Physical Activity | Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months | Posted | Mean | Standard Deviation | steps | 3 months |
|
|
|
| Secondary | Change in the Self-Management Ability Scale (SMAS) Total Score | Measured using the total score from the self-reported SMAS 30 item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. The SMAS30 has six areas, each with 5 questions. The minimum score is one and the max is 5. The mean is calculated for each section. A higher score indicates better self management. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
|
| Secondary | Change in Patient Health Questionnaire (PHQ-2) | Measured using the self-reported PHQ-2 consisting of a 2 item questionnaire inquiring about the frequency of depressed mood over the past 2 weeks on a scale of 0 to 3, 0=Not at all, 1=several days, 2=more than half the days, 3=nearly everyday. The minimum score is zero and the highest score is 6. A score greater than 3 may indicate depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
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|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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