NCT03652662: RESP-FIT

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

Completed NA Results posted Last updated 30 March 2021

What this trial tests

NA trial testing RESP-FIT in COPD in 34 participants. Completed in 13 January 2020.

Timeline

18 January 2018

Primary endpoint
13 January 2020

13 January 2020

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	34
Start date	18 January 2018
Primary completion	13 January 2020
Estimated completion	13 January 2020
Sites	1 location across United States

Drugs / interventions tested

• RESP-FIT
• RESP-FIT Comparator

Conditions studied

• COPD — all drugs for COPD →

Sponsor

Medical University of South Carolina

Who can join

40 and older, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention Feasibility (Number of Participants Who Adhered to Treatment) Primary · 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).

Group	Value	95% CI
RESP-FIT Intervention	13
RESP-FIT Comparator	14

Change in Self-efficacy Secondary · 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.

Group	Value	95% CI
RESP-FIT Intervention	6.0	± 1.9
RESP-FIT Comparator	6.7	± 2.3

Change in Fatigue Secondary · 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 negativ

Group	Value	95% CI
RESP-FIT Intervention	61.8	± 8.8
RESP-FIT Comparator	57.8	± 8.7

Dyspnea Secondary · 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 calib

Group	Value	95% CI
RESP-FIT Intervention	58.9	± 8.8
RESP-FIT Comparator	55.4	± 10.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RESP-FIT Intervention

Serious: 0/15 (0%)

Deaths: 0/15

RESP-FIT Comparator

Serious: 2/15 (13%)

Deaths: 0/15

Serious adverse events (2 terms)

Reaction	System	RESP-FIT Intervention	RESP-FIT Comparator
Gastroparesis	Gastrointestinal disorders	—	—
TIA	Cardiac disorders	—	—

Most-reported serious reactions: Gastroparesis, TIA.

Data from ClinicalTrials.gov NCT03652662 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility of RESP-FIT: Technology-Enhanced Self-Management Intervention for Adults with COPD.
   Miller S, Teufel R, Nichols M, Davenport P, et al · · 2021 · cited 10× · PMID 34887656 · DOI 10.2147/copd.s326675
2. RESP-FIT: A Technology-Enhanced Combined Inspiratory and Expiratory Muscle Strength Training Intervention for Adults With COPD.
   Miller SN, Mueller M, Nichols M, Teufel RJ, et al · · 2024 · PMID 39357505 · DOI 10.15326/jcopdf.2024.0523