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

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT03652662
• Collaborator: University of Florida (Other)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

30 adults, aged 40 and older with mild to moderate COPD, will be recruited for this study. Participants must be willing to continually wear a FitBit activity monitor, have access to a smartphone or Wi-Fi/Data-enabled iPad, and be willing to complete respiratory muscle strength training exercises as well as reports on their smartphone at least 5 times per week for a 6-week period. Participants will be given a bluetooth inhaler device and a training app (RESP-FIT). This application will collect inhaler data and allows patients to self-report their daily symptoms. The goal of this study is to test whether use of the personalized inhaler device with the app strengthens lung function, promotes physical activity, and improves disease symptom self-management in persons with COPD.

Condition or Disease	Intervention/Treatment	Phase
COPD	Device: RESP-FIT; Behavioral: RESP-FIT Comparator	N/A

Detailed Description

RESP-FIT. The RESP-FIT program is a 6-week respiratory muscle strength training intervention adapted from previous respiratory muscle strength training (RMST) training regimens, consisting of 1) five training days/week using combined inspiratory and expiratory muscle training, consisting of breathing in and out against a combine inspiratory and expiratory muscle strength trainer (IMST/EMST), 2) individualized, progress-based text message training reminders and prompts related to timing and intensification calibration, and 3) use of a Fitbit for remote monitoring of physical activity and hours slept at night. Similar to other muscle strength training programs, exercises are done at regular intervals during the week (5 breaths, 5 times a day, 5 days a week; the participant will receive graphical illustration of RESP-FIT training frequency and intensity achieved, and based on their training regimen, will be prompted and/or reinforced via SMS text messaging). As the use of an accelerometer or remote tracking device alone may affect physical activity, a control group will receive only the Fitbit. This study proposes to assess the feasibility and initial efficacy of RMST by obtaining estimates of variability in fatigue secondary to dyspnea, using a technologically-enhanced RESP-FIT intervention. Our overarching hypothesis is that a training regimen consisting of RMST along with technology-enhanced symptom-tracking will decrease dyspnea, dyspnea-related activity avoidance, and fatigue. Additionally, this application proposes to further develop Smartphone Airway Monitoring System (SAMS) which currently integrates EMA probe questions covering COPD symptoms and preventive care use with the new functions, use in an adult population with COPD, video captured training technique and logging of RMST training sessions. Up to thirty adults with COPD (age over 40) will complete the study and use the SAMS app for 6 weeks in the natural environment. We will evaluate the acceptability, feasibility, adherence, and performance of RESP-FIT + SAMS through quantitative methods to further optimize the app and related study procedures for the next phase of testing (i.e., large scale efficacy RCT).

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a randomized longitudinal controlled observational study. The study will recruit 30 participants and utilize a control group experimental design with dependent pretest and posttest to derive data regarding (1) feasibility and (2) within-participant effect size of the RESP-FIT intervention in terms of satisfaction, use and adherence, technical issues and acceptability, and self-reported symptom severity (dyspnea and fatigue). When completed, 30 adults (15 in each group) will have used SAMS for 6 weeks.This is a randomized longitudinal controlled observational study. The study will recruit 30 participants and utilize a control group experimental design with dependent pretest and posttest to derive data regarding (1) feasibility and (2) within-participant effect size of the RESP-FIT intervention in terms of satisfaction, use and adherence, technical issues and acceptability, and self-reported symptom severity (dyspnea and fatigue). When completed, 30 adults (15 in each group) will have used SAMS for 6 weeks.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: RESP-FIT: Technology-Enhanced Self-Management in COPD
• Actual Study Start Date: Jan 18, 2018
• Actual Primary Completion Date: Jan 13, 2020
• Actual Study Completion Date: Jan 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Device: 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); Other Names: Combined IMST/EMST
Active Comparator: RESP-FIT Comparator Active Comparator: Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)	Behavioral: RESP-FIT Comparator; Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS); Other Names: Activity and Symptom Monitoring Only

Outcome Measures

Primary Outcome Measures

1. Intervention Feasibility (Number of Participants Who Adhered to Treatment) [through study completion, average of 6 weeks]

   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).

Secondary Outcome Measures

1. Change in Self-efficacy [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.

2. Change in Fatigue [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.

3. Dyspnea [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 40 years of age or older; and

• Able to read and write English; and

• Diagnosed with mild to moderate COPD (PFT values: FEV1/FVC <0.7 and FEV1% predicted < 50% - within the past 6 months); and

• Dyspnea score of greater than "2" on the Modified Medical Research Council (MMRC) questionnaire.

Exclusion Criteria:

• • Pregnant female or less than 1 year post-partum; or

• Diagnosed cognitive deficit or observed lack of understanding during the informed consent process; or

• Mobility impairment; or

• Lack of 3g WiFi access in place of residence; or

• Unwillingness to wear physical activity tracker daily, follow protocol, and/ or attend study visits.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina
• University of Florida

Investigators

• Principal Investigator: Sarah Miller, PhD, RN, Medical University of South Carolina

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 14, 2019
• Informed Consent Form - May 14, 2019

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03652662
• Other Study ID Numbers: Pro00071706
• First Posted: Aug 29, 2018
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	RESP-FIT Intervention	RESP-FIT Comparator
Arm/Group Description	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)	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)
Period Title: Overall Study
STARTED	18	16
COMPLETED	15	15
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	RESP-FIT Intervention	RESP-FIT Comparator	Total
Arm/Group Description	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)	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 of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 93.3%	11 73.3%	25 83.3%
>=65 years	1 6.7%	4 26.7%	5 16.7%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	62	53	58
Sex: Female, Male (Count of Participants)
Female	10 66.7%	9 60%	19 63.3%
Male	5 33.3%	6 40%	11 36.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	15 100%	15 100%	30 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 26.7%	4 26.7%	8 26.7%
White	11 73.3%	11 73.3%	22 73.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%
Forced Expiratory Volume by spirometry (L/sec) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [L/sec]	55.7 (17)	55.5 (17.4)	55.6 (17.2)

Outcome Measures

1. Primary Outcome

Title	Intervention Feasibility (Number of Participants Who Adhered to Treatment)
Description	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).
Time Frame	through study completion, average of 6 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	RESP-FIT Intervention	RESP-FIT Comparator
Arm/Group Description	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)	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)
Measure Participants	15	15
Count of Participants [Participants]	13 86.7%	14 93.3%

2. Secondary Outcome

Title	Change in Self-efficacy
Description	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.
Time Frame	baseline, 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RESP-FIT Intervention	RESP-FIT Comparator
Arm/Group Description	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)	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)
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	6.0 (1.9)	6.7 (2.3)

3. Secondary Outcome

Title	Change in Fatigue
Description	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.
Time Frame	baseline, 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RESP-FIT Intervention	RESP-FIT Comparator
Arm/Group Description	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)	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)
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	61.8 (8.8)	57.8 (8.7)

4. Secondary Outcome

Title	Dyspnea
Description	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.
Time Frame	baseline, 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RESP-FIT Intervention	RESP-FIT Comparator
Arm/Group Description	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)	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)
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	58.9 (8.8)	55.4 (10.3)

Adverse Events

Time Frame	1 year
Arm/Group Title	RESP-FIT Intervention		RESP-FIT Comparator
Arm/Group Description	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)		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)
All Cause Mortality
	RESP-FIT Intervention		RESP-FIT Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	RESP-FIT Intervention		RESP-FIT Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		2/15 (13.3%)
Cardiac disorders
TIA	0/15 (0%)		1/15 (6.7%)	1
Gastrointestinal disorders
Gastroparesis	0/15 (0%)		1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	RESP-FIT Intervention		RESP-FIT Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.