Trial Outcomes & Findings for RESP-FIT: Technology-Enhanced Self-Management in COPD (NCT NCT03652662)

Last Updated: 2021-03-30

Results Overview

Feasibility of intervention was measured by the number of participants who adhered to treatment and completed the trial (from baseline to final visit follow-up). Treatment acceptability was measured by the Mobile Application Rating Scale. The Mobile Application Rating Scale asks the participant to report the appropriateness of the app for his/her target audience ranging from little or no (1) to very high level of the acceptability measure (5).

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

through study completion, average of 6 weeks

Results posted on

2021-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	RESP-FIT Intervention Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
Overall Study STARTED	18	16
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	RESP-FIT Intervention Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

RESP-FIT: Technology-Enhanced Self-Management in COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RESP-FIT Intervention n=15 Participants Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator n=15 Participants Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	11 Participants n=4 Participants	25 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Age, Continuous	62 years n=93 Participants	53 years n=4 Participants	58 years n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	9 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants
Forced Expiratory Volume by spirometry	55.7 L/sec STANDARD_DEVIATION 17 • n=93 Participants	55.5 L/sec STANDARD_DEVIATION 17.4 • n=4 Participants	55.6 L/sec STANDARD_DEVIATION 17.2 • n=27 Participants

PRIMARY outcome

Timeframe: through study completion, average of 6 weeks

Population: 15 participants were initially enrolled in both groups, 13 participants in the intervention group completed the trial, and 14 in the comparator group.

Outcome measures

Outcome measures
Measure	RESP-FIT Intervention n=15 Participants Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator n=15 Participants Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
Intervention Feasibility (Number of Participants Who Adhered to Treatment)	13 Participants	14 Participants

SECONDARY outcome

Timeframe: baseline, 6 weeks

Change in self-efficacy (measured with the PROMIS Self-Efficacy Scale). This measures the individual's confidence in his/her ability to successfully perform specific tasks or behaviors related to one's health, with 0 being "not at all confident" to 10 being "totally confident." The PROMIS adult Self-Efficacy item banks assess self-reported current level of confidence in managing chronic conditions, including confidence in managing daily activities, managing emotions, managing medications and treatments, managing social interactions and managing symptoms.

Outcome measures

Outcome measures
Measure	RESP-FIT Intervention n=15 Participants Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator n=15 Participants Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
Change in Self-efficacy	6.0 score on a scale Standard Deviation 1.9	6.7 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: baseline, 6 weeks

Change in fatigue (measured with the PROMIS v1.0 Fatigue Scale). The PROMIS Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a T-score of 60 is one SD worse than average.

Outcome measures

Outcome measures
Measure	RESP-FIT Intervention n=15 Participants Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator n=15 Participants Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
Change in Fatigue	61.8 score on a scale Standard Deviation 8.8	57.8 score on a scale Standard Deviation 8.7

SECONDARY outcome

Timeframe: baseline, 6 weeks

Change in difficulty breathing (measured with the PROMIS v1.0 Dyspnea). Participant can select from 5 items evaluating how shortness of breath over the past 7 days affected ability to do various activities (Getting dressed, walking stairs, household chores, or walking fast pace) ranging from "I did not do this," "no difficulty," "a little difficulty," "some difficulty," and "much difficulty." A score of 50 is the average for the general population with a standard deviation of 10 as calibration testing was performed on a large sample of the general population. The dyspnea instruments were calibrated on a sample of adults with COPD, so a score of 50 is the average for people with COPD. For the adult PROMIS Dyspnea Severity 10a short form, a raw score of 10 converts to a T-score of 48.8 with a standard error (SE) of 2.0, for an average dyspnea rating. The T-score can range from 29.7-76.7. A higher score represents more dyspnea being measured.

Outcome measures

Outcome measures
Measure	RESP-FIT Intervention n=15 Participants Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator n=15 Participants Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
Dyspnea	58.9 score on a scale Standard Deviation 8.8	55.4 score on a scale Standard Deviation 10.3

Adverse Events

RESP-FIT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RESP-FIT Comparator

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RESP-FIT Intervention n=15 participants at risk Intervention: IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS) RESP-FIT: Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	RESP-FIT Comparator n=15 participants at risk Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS) RESP-FIT Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
Gastrointestinal disorders Gastroparesis	0.00% 0/15 • 1 year	6.7% 1/15 • Number of events 1 • 1 year
Cardiac disorders TIA	0.00% 0/15 • 1 year	6.7% 1/15 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Sarah Miller, PhD, RN

MUSC

Phone: 8427921692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place