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

NCT03652662 | Completed Results DMC

• 1 other identifier: Pro00071706
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

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).

  through study completion, average of 6 weeks

Secondary Outcomes (3)

• Change in Self-efficacy

  baseline, 6 weeks

• Change in Fatigue

  baseline, 6 weeks

• Dyspnea

  baseline, 6 weeks

Study Arms (2)

RESP-FIT Intervention

EXPERIMENTAL

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

RESP-FIT Comparator

ACTIVE COMPARATOR

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

Behavioral: RESP-FIT Comparator

Interventions

RESP-FIT DEVICE

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

RESP-FIT Intervention

RESP-FIT Comparator BEHAVIORAL

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

Also known as: Activity and Symptom Monitoring Only

RESP-FIT Comparator

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• University of Florida: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Sarah Miller, PhD, RN
• Organization: MUSC

millesar@musc.edu

8427921692

Study Officials

• Sarah Miller, PhD, RN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 29, 2018
• Study Start: January 18, 2018
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2021-03

Locations

US (1)