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

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• Pulmonary Disease, Chronic Obstructive 4,131

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 34 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Study arms

• 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

• 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

Interventions

• DeviceRESP-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)

  Also known as: Combined IMST/EMST

• BehavioralRESP-FIT Comparator

  Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)

  Also known as: Activity and Symptom Monitoring Only

Primary outcomes

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

   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

Secondary outcomes

1. Change in Self-efficacy

   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

2. Change in Fatigue

   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

3. Dyspnea

   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

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · May 14, 2019
• Informed consent form · May 14, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — As a condition of this National Institutes of Nursing Research (NINR) award, de-identified patient data will be shared by the researchers with the NINR and stored electronically on an NIH password protected secure server (https://cdrns.nih.gov/). The purpose of sharing this information is to build a NINR repository of data using Common Data Elements (CDE) for future research purposes among the general scientific community and for public health benefit.