Trial Outcomes & Findings for A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients (NCT NCT04517500)
NCT ID: NCT04517500
Last Updated: 2024-11-08
Results Overview
The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea.
COMPLETED
PHASE3
99 participants
Baseline, 3 months, 6 months
2024-11-08
Participant Flow
Participant milestones
| Measure |
Home-base Pulmonary Rehabilitation With Mindful Breathing Module
Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet.
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen.
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
Home-base Pulmonary Rehabilitation
Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Home-based Module to Promote Mindful Breathing Awareness for COPD Patients
Baseline characteristics by cohort
| Measure |
Home-base Pulmonary Rehabilitation With Mindful Breathing Module
n=48 Participants
Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet.
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen.
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
Home-base Pulmonary Rehabilitation
n=51 Participants
Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.551 years
STANDARD_DEVIATION 6.894 • n=99 Participants
|
70.103 years
STANDARD_DEVIATION 8.922 • n=107 Participants
|
69.832 years
STANDARD_DEVIATION 7.957 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=99 Participants
|
51 participants
n=107 Participants
|
99 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: For the Home-based pulmonary rehabilitation with mindful breathing module arm, nineteen subjects did not complete the three months or six months questionnaire. Data was not collected or analyzed. For the Home-base pulmonary rehabilitation arm, twenty-six subjects did not complete the three months questionnaire and twenty-eight subjects did not complete the six months questionnaire. Data was not collected or analyzed.
The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total scores range from 5 - 35. Lower scores indicated higher severity of dyspnea. Higher scores indicate less severity of dyspnea.
Outcome measures
| Measure |
Home-base Pulmonary Rehabilitation
n=25 Participants
Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
Home-base Pulmonary Rehabilitation With Mindful Breathing Module
n=29 Participants
Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet.
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen.
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
|---|---|---|
|
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score
baseline, 6 months
|
0.83 score on a scale
Interval 0.11 to 1.55
|
0.34 score on a scale
Interval -0.03 to 0.71
|
|
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Score
baseline, 3 months
|
0.71 score on a scale
Interval 0.19 to 1.22
|
0.68 score on a scale
Interval 0.36 to 1.0
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: For the Home-based pulmonary rehabilitation with mindful breathing module arm, nineteen subjects did not complete the three months or six months questionnaire. Data was not collected or analyzed. For the Home-base pulmonary rehabilitation arm, twenty-five subjects did not complete the three months questionnaire and twenty-eight subjects did not complete the six months questionnaire. Data was not collected or analyzed.
The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 (All of the time) to 7 (None of the time). Total scores range from 7-49. Lower scores indicate more severity of emotions. Higher scores indicate less severity of emotions.
Outcome measures
| Measure |
Home-base Pulmonary Rehabilitation
n=26 Participants
Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
Home-base Pulmonary Rehabilitation With Mindful Breathing Module
n=29 Participants
Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet.
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen.
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
|---|---|---|
|
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score
baseline, 3 months
|
0.55 score on a scale
Interval 0.14 to 0.97
|
0.45 score on a scale
Interval 0.01 to 0.88
|
|
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Score
baseline, 6 months
|
0.5 score on a scale
Interval -0.07 to 1.06
|
0.35 score on a scale
Interval 0.04 to 0.66
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: For the Home-based pulmonary rehabilitation with mindful breathing module arm, twenty-one subjects did not complete the three months or six months questionnaire. Data was not collected or analyzed. For the Home-base pulmonary rehabilitation arm, twenty-five subjects did not complete the three months questionnaire and thirty subjects did not complete the six months questionnaire. Data was not collected or analyzed.
Mean change in the number of steps per day
Outcome measures
| Measure |
Home-base Pulmonary Rehabilitation
n=26 Participants
Subjects completed a 12-week home-based pulmonary rehabilitation with health coaching
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
Home-base Pulmonary Rehabilitation With Mindful Breathing Module
n=27 Participants
Subjects completed a home-based pulmonary rehabilitation program and in addition completed a mindful breathing practice using a module on a computer tablet.
Home-based pulmonary rehabilitation program: Subjects wore an activity monitor while doing at home exercises using a computer tablet
Mindful breathing module: Additional module on the computer tablet that involved inhaling and exhaling while following an animated ball on the computer screen.
Health coaching: Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
|
|---|---|---|
|
Change in Daily Physical Activity
baseline, 3 months
|
701.5 steps per day
Interval -49.43 to 1452.43
|
765.98 steps per day
Interval 46.16 to 1485.79
|
|
Change in Daily Physical Activity
baseline, 6 months
|
290.36 steps per day
Interval -537.44 to 1118.17
|
-181.78 steps per day
Interval -987.65 to 624.09
|
Adverse Events
Home-base Pulmonary Rehabilitation With Mindful Breathing Module
Home-base Pulmonary Rehabilitation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place