COPD Exacerbation
Conditions
Brief summary
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.
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. 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).
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)
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to One Balance Practice Routine | Baseline to 3 months | 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 |
| Adherence to Two Balance Practice Routine | Baseline to 3 months | 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 |
| Adherence to Daily Flexible Practice Routine | Baseline to 3 months | 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 |
| Completion of the Daily Self-assessment | Baseline to 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary | Baseline, 3 months | 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. |
| Change in Patient Health Questionnaire (PHQ-2) | Baseline, 3 months | 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. |
| Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary | Baseline, 3 months | 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. |
| Daily Physical Activity | 3 months | Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months |
| Change in the Self-Management Ability Scale (SMAS) Total Score | Baseline, 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Intervention- Home Pulmonary Rehabilitation | — |
|---|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 5.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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
Time frame: Baseline to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Adherence to Daily Flexible Practice Routine | 54 percentage of participants |
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
Time frame: Baseline to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Adherence to One Balance Practice Routine | 49 percentage of participants |
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
Time frame: Baseline to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Adherence to Two Balance Practice Routine | 42 percentage of participants |
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
Time frame: Baseline to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Completion of the Daily Self-assessment | 61 percentage of participants |
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary | 0.6 score on a scale | Standard Deviation 1.7 |
p-value: 0.01t-test, 2 sided
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary | 0.5 score on a scale | Standard Deviation 1.6 |
p-value: 0.13t-test, 2 sided
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in Patient Health Questionnaire (PHQ-2) | -0.6 score on a scale | Standard Deviation 1.9 |
p-value: 0.25t-test, 2 sided
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Change in the Self-Management Ability Scale (SMAS) Total Score | 3.8 score on a scale | Standard Deviation 13 |
p-value: 0.1t-test, 2 sided
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Home Pulmonary Rehabilitation | Daily Physical Activity | 4086.3 steps | Standard Deviation 2552.2 |