Clinical trial NCT03652662: RESP-FIT: Technology-Enhanced Self-Management in COPD
Official title: RESP-FIT: Technology-Enhanced Self-Management in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2018-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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).

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.

Primary outcomes:
measure: Intervention Feasibility (Number of Participants Who Adhered to Treatment)
timeFrame: through study completion, average of 6 weeks
Secondary outcomes:
measure: Change in Self-efficacy
timeFrame: baseline, 6 weeks
measure: Change in Fatigue
timeFrame: baseline, 6 weeks
measure: Dyspnea
timeFrame: baseline, 6 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sarah Miller, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: