Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
AFTER
1 other identifier
interventional
49
1 country
1
Brief Summary
The aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized due to COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Dec 2020
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedStudy Start
First participant enrolled
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2021
CompletedResults Posted
Study results publicly available
November 4, 2022
CompletedNovember 4, 2022
October 1, 2022
8 months
December 8, 2020
August 12, 2022
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adherence (Primary Feasibility/Safety Outcome)
Feasibility will be measured by program adherence, defined as the number of sessions attended divided by the total number of prescribed sessions (n=12). Individuals will be considered adherent if they attend at least 75% (n=9) of the total sessions. Adherence will be collected in the intervention group only.
12 weeks
Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. To facilitate accuracy of the test over video, the participant will be instructed to count out loud each time he/she stands. Further, the test will also be facilitated by the Platform.
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary Outcomes (14)
System Usability Scale (SUS)
6 weeks (primary end point)
Safety Event Count
Week 12
Timed Up-and-Go Test (TUG)
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
4-Stage Balance Test
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
MRC Dyspnea
Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
- +9 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALThis group will receive 12 biobehaviorally informed tele-rehabilitation sessions including high-intensity strengthening; sessions will be delivered by a licensed physical therapist. An application ('Platform') will facilitate home exercise program completion outside of the supervised sessions. Other: remote controlled exercise plus home exercise Treatments: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
Control
NO INTERVENTIONThis group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training. Other: basic education
Interventions
Biobehavioral tele-rehabilitation sessions
Eligibility Criteria
You may qualify if:
- Confirmed COVID-19, per diagnostic criteria (PCR testing)
- Hospitalized for at least 24 hours
- Able to provide informed consent
- Internet capability to access the platform
- Community-dwelling prior to hospitalization
You may not qualify if:
- Unstable medical comorbidities that would preclude participation in exercise
- Receipt of \>1 session of outpatient physical therapy
- Known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of COVID-19
- Anticipating concurrent additional physical therapy services during study intervention period (12 weeks)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Related Publications (2)
Churchill L, Morrow M, Capin JJ, Jolley SE, Hare K, MaWhinney S, Stevens-Lapsley JE, Erlandson KM. Using Wearable Technology to Quantify Physical Activity Recovery: Secondary Report From the AFTER (App-Facilitated Tele-Rehabilitation) Program for COVID-19 Survivors Randomized Study. JMIR Rehabil Assist Technol. 2023 Mar 20;10:e43436. doi: 10.2196/43436.
PMID: 36939818DERIVEDCapin JJ, Jolley SE, Morrow M, Connors M, Hare K, MaWhinney S, Nordon-Craft A, Rauzi M, Flynn S, Stevens-Lapsley JE, Erlandson KM. Safety, feasibility and initial efficacy of an app-facilitated telerehabilitation (AFTER) programme for COVID-19 survivors: a pilot randomised study. BMJ Open. 2022 Jul 26;12(7):e061285. doi: 10.1136/bmjopen-2022-061285.
PMID: 35882451DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jennifer Stevens-Lapsley
- Organization
- University of Colorado Denver
Study Officials
- PRINCIPAL INVESTIGATOR
Kristine Erlandson, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2020
First Posted
December 11, 2020
Study Start
December 11, 2020
Primary Completion
August 12, 2021
Study Completion
December 27, 2021
Last Updated
November 4, 2022
Results First Posted
November 4, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The main study results will be posted in ClinicalTrials.gov and will remain there indefinitely. All other study documents and data will be made available within a reasonable time frame following a valid written request.
- Access Criteria
- Other related study documents will be made available upon reasonable written request
Upon written request of the study team and an established data use agreement (DUA) between the University of Colorado Anschutz Medical Campus (UCD-AMC) and the requestor's institution, we will provide a deidentified dataset including a data dictionary. Deidentification of the datasets will be conducted with respect to HIPAA definitions, with add back of variables that express all dates as number of days since a milestone event, enrollment, and a variable storing just the year. For example, the milestone event would be "Day 0" in this case.