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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04663945
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
12.6
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Biobehavioral Tele-rehabilitation Sessions
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID Survivors
Actual Study Start Date :
Dec 11, 2020
Actual Primary Completion Date :
Aug 12, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 30 Second Chair Stand Test [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

Secondary Outcome Measures

  1. Adherence [12 weeks]

    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. Secondary adherence will be measured by the number of days the HEP is completed divided by the total number of prescribed sessions. Adherence will be collected in the intervention group only.

  2. System Usability Scale (SUS) [6 weeks (primary end point)]

    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.

  3. Safety Event Count [Week 12]

    The Safety Event Count is the cumulative number of adverse events and severe adverse events counted from baseline to week 12. Events will be categorized by type.

  4. Timed Up-and-Go Test (TUG) [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  5. 4-Stage Balance Test [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  6. MRC Dyspnea [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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

  7. Activities-Specific Balance Confidence (ABC) Scale [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  8. Three-Item Loneliness Scale [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  9. PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  10. PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  11. PROMIS Scale v1.2 Global Health: [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  12. Montreal Cognitive Assessment (MoCA)-BLIND [Change from Baseline to week 12]

    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.

  13. Clinical Frailty Scale [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

  14. Average Daily Step Count [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    Average Daily Step Count per week will be collected via a Fitbit activity monitor. Higher step counts indicate higher level of physical activity.

  15. Patient Health Questionnaire 8 (PHQ8) [Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Colorado HospitalAuroraColoradoUnited States80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Jennifer Stevens-Lapsley, MPT, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT04663945
Other Study ID Numbers:
  • 20-2415
First Posted:
Dec 11, 2020
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021