Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors (AFTER)

Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID Survivors

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.

Study Overview

• Status: Completed
• Conditions: Covid-19; Deconditioning
• Intervention / Treatment: Behavioral: Biobehavioral Tele-rehabilitation Sessions

Detailed Description

The aim of this study is to investigate the feasibility and initial efficacy of a multicomponent tele-rehabilitation program during COVID-19 recovery. The tele-rehabilitation program will include biobehavioral training and high intensity exercise facilitated through an online application ('Platform'). Initial efficacy will be assessed primarily by performance on the 30" Chair Stand Test and secondarily through other physical function tests and patient reported outcome measures.

This study will advance the feasibility of tele-rehabilitation as a more generally useful intervention in patients lacking access (distance, availability, mobility) to standard rehabilitative services and could transform the way in which acute rehabilitation and post-hospital care is delivered for all patients.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Confirmed COVID-19, per diagnostic criteria (PCR testing)
2. Hospitalized for at least 24 hours
3. Able to provide informed consent
4. Internet capability to access the platform
5. Community-dwelling prior to hospitalization

Exclusion Criteria:

1. Unstable medical comorbidities that would preclude participation in exercise
2. Receipt of >1 session of outpatient physical therapy
3. Known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of COVID-19
4. Anticipating concurrent additional physical therapy services during study intervention period (12 weeks)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This 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	Behavioral: Biobehavioral Tele-rehabilitation Sessions; Biobehavioral tele-rehabilitation sessions
No Intervention: Control; This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training. Other: basic education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS)	The SUS is a 10-item survey that uses a 5-point Likert scale (Strongly disagree (1) to Strongly agree (5)). Scores range from 0 to 100 and higher scores indicate better usability. The SUS will be collected in the intervention group only.	6 weeks (primary end point)
Safety Event Count	The Safety Event Count is the cumulative number of participants who experienced adverse events and severe adverse events counted from baseline to week 12. Events will be categorized by type.	Week 12
Timed Up-and-Go Test (TUG)	The TUG test measures the time it takes for a person to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Participants will complete the TUG test twice and the best time will be used. Faster times indicate better physical function and lower risk of falls.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
4-Stage Balance Test	The 4-stage balance test measures static balance in 4 different positions (narrow base of support, semi-tandem, tandem, and single-leg). The test is facilitated by the Platform; it requires participants to hold each position for up to 10 seconds. If a participant is unable to hold a position for 10 seconds, the next hardest position is not performed. Completing higher levels indicate lesser fall risk and better balance. Total scores range from 0 to 40, with higher scores indicating better outcomes.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
MRC Dyspnea	The MRC dyspnea scale is an interviewer-administered or self-report assessment of the perception of difficulty breathing during five different tasks. Participants respond either yes or no to each task. Score is the sum of the number of Yes answers, 0-5. Higher numbers indicate more difficulty breathing	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Activities-Specific Balance Confidence (ABC) Scale	The ABC Scale is a 16-item self-report measure of balance confidence in performing activities without losing balance or experiencing a sense of unsteadiness. Score range: 0-100. Higher scores indicate higher confidence in performing activities without losing balance.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Three-Item Loneliness Scale	This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a	The PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a consists of 4 items rated on a 5-point Likert scale (not at all confident (1) to very confident (5)); values range from 4-20. Higher scores indicate higher levels of general self-efficacy.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions	The PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions is an 8-item scale rated on a 5-point Likert scale;values range from 8-32. Higher scores indicate higher levels of self confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
PROMIS Scale v1.2 Global Health:	The PROMIS Scale v1.2 Global Health measures quality of life on two domains: physical and mental health. Raw values for each domain range from 4 - 20; scores are converted to a t-score with a mean of 50 and SD of 10. Higher scores indicate better health.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Montreal Cognitive Assessment (MoCA)-BLIND	The MoCA-BLIND assesses different cognitive domains: attention, concentration, memory, language, conceptual thinking, calculations, and orientation. The MoCA-BLIND has removed assessments requiring vision, thus can be completed using telehealth or telephone assessments. Score range: 0-22, with 18-22 normal range.	Change from Baseline to week 12
Clinical Frailty Scale	The Clinical Frailty scale is a self-report scale to estimate function. The participant selects perceived level of function prior to and following admission ranging from very active to bedridden/terminal. Score range: 1 (very fit) - 9 (terminally ill), with higher scores indicating higher levels of frailty.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Average Daily Step Count	Average Daily Step Count per week will be collected via a Fitbit activity monitor. Higher step counts indicate higher level of physical activity.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Patient Health Questionnaire 8 (PHQ8)	The Patient Health Questionnaire 8 measures severity of depressive symptoms over the past 2 weeks. The 8 item scale is rated on a 4 point scale (not at all to nearly every day). Score range: 0-24. Higher scores indicate more severe depressive symptoms.	Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kristine Erlandson, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Capin 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): August 12, 2021
• Study Completion (Actual): December 27, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Tele-rehabilitation; High Intensity; Biobehavioral; Activity Self-Monitoring; Physical Functional Performance
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20-2415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Other related study documents will be made available upon reasonable written request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No