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Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth

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ClinicalTrials.gov Identifier: NCT04385901
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer Y Stone, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE May 6, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date June 5, 2020
Actual Study Start Date  ICMJE May 19, 2020
Estimated Primary Completion Date April 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Change in 6 Minute Walk Test [ Time Frame: From 6 to 24 months post diagnosis ]
    Validated test demonstrating functional gait capacity and endurance; measuring change in capacity over time in 6 month increments.
  • Change in Short Form 35 (SF-36) Questionnaire [ Time Frame: From 6 to 24 months post diagnosis ]
    Validated questionnaire assessing function and quality of life for patients with pulmonary function issues
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Change in 6 Minute Walk Test [ Time Frame: From 6 to 24 months post diagnosis ]
    Validated test demonstrating functional gait capacity and endurance; measuring change in capacity over time in 6 month increments.
  • Change in SF-36 Questionnaire [ Time Frame: From 6 to 24 months post diagnosis ]
    Validated questionnaire assessing function and quality of life for patients with pulmonary function issues
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Change in Strength testing [ Time Frame: From 6 to 24 months post diagnosis ]
    Use of grip dynamometer and isokinematic lower extremity testing to determine muscle capacity
  • Change in Peak Flow Meter Test [ Time Frame: From 6 to 24 months post diagnosis ]
    Measures lung output capacity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth
Official Title  ICMJE Long Term Functional Outcomes of COVID-19 Patients Treated by Rehabilitation Services viaTelehealth
Brief Summary This study seeks to assess the impact of physical and pulmonary rehabilitation on patients who have been diagnosed with COVID-19 in the short and long term in hopes of establishing a best practices protocol for treatment of future patients with this disease.
Detailed Description The novel coronavirus that began in Wuhan, China in late 2019 made an appearance in the United States in January 2020. It is a respiratory disease spreading rapidly from person to person. Recent data shows that fibrosis is seen on the lungs, and possible myocardial damage. Data shows that physical therapy was not highly utilized in recovery for these patients due to high PPE demands, and increased risk of exposure. This study will be using telehealth services to assess and treat these patients so Physical Therapy guidance is provided for movement and returning to prior level of function. Currently there is no data showing the long term effects of the those who were able to utilize Physical Therapy in recovering from COVID-19 This study will be looking at the differences in outcomes of COVID-19 positive subjects who able to complete Physical Therapy Telehealth visits versus those who did not. All groups will be tested at multiple data points for lung capacity, upper and lower extremity strength, and overall endurance to determine the long term functional effects. The control group were diagnosed with COVID-19 and recovered before the Physical and Pulmonary protocol was implemented.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients receiving care through the program developed by the University of Missouri Healthcare system will, if willing, return for follow up testing and be compared against a matched group that did not receive the rehabilitative treatment to see if there are short or long term differences.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Participants and care providers will know which group they are in, but data will be deidentified and blinded prior to analysis or viewing by the primary investigator
Primary Purpose: Treatment
Condition  ICMJE
  • SARS-CoV 2
  • SARS Pneumonia
Intervention  ICMJE Behavioral: Therapy Intervention
Patients receive 2-4 visits (based on patient presentation and need) of physical therapy, up to 4 visits of occupational therapy, up to 4 visits of speech therapy based on need. Treatment focuses on physical strengthening, pulmonary strengthening/breathing exercises, and cognitive rehabilitation.
Study Arms  ICMJE
  • No Intervention: Standard of Care
    These are patients who were diagnosed with COVID19 and recovered with usual care prior to implementation of the rehabilitation program developed by MUHC therapists. These patients will be selected in such a way as to match the approximate demographics that exist within the treatment group. These patients received education and supportive care only.
  • Experimental: Rehabilitation Group
    These are patients who were diagnosed with COVID19 and participated in the physical and pulmonary rehabilitation program developed at MU Healthcare as described in the study design.
    Intervention: Behavioral: Therapy Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2020)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 19, 2022
Estimated Primary Completion Date April 19, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >Age of 18
  • Positive COVID-19 diagnosis in the last 6 months

Exclusion Criteria:

  • Age of <18
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04385901
Other Study ID Numbers  ICMJE COVID19Recovery
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer Y Stone, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Missouri-Columbia
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP