N/A
N=34
RESP-FIT: Technology-Enhanced Self-Management in COPD
COPD
Bottom Line
View on ClinicalTrials.gov: NCT03652662 ↗Enrolled (actual)
34
Serious AEs
6.7%
Results posted
Mar 2021
Primary outcome: Primary: Intervention Feasibility (Number of Participants Who Adhered to Treatment) — 13; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RESP-FIT (Device); RESP-FIT Comparator (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility (Number of Participants Who Adhered to Treatment) |
13; 14 | — |
| SECONDARY Change in Self-efficacy |
6.0; 6.7 | — |
| SECONDARY Change in Fatigue |
61.8; 57.8 | — |
| SECONDARY Dyspnea |
58.9; 55.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03652662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.