NCT04663945: AFTER

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

Completed NA Results posted Last updated 4 November 2022

What this trial tests

NA trial testing Biobehavioral Tele-rehabilitation Sessions in Covid-19 in 49 participants. Completed in 27 December 2021.

Timeline

11 December 2020

Primary endpoint
12 August 2021

27 December 2021

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	49
Start date	11 December 2020
Primary completion	12 August 2021
Estimated completion	27 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Biobehavioral Tele-rehabilitation Sessions

Conditions studied

• Covid-19 — all drugs for Covid-19 →
• Deconditioning — all drugs for Deconditioning →

Sponsor

University of Colorado, Denver

Who can join

Adults 35 to 100, any sex, with Covid-19 or Deconditioning. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adherence (Primary Feasibility/Safety Outcome) Primary · 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. Adherence will be collected in the intervention group only.

Group	Value	95% CI
Intervention	93	77 – 99

Change in 30 Second Chair Stand Test (Primary Efficacy Outcome) Primary · 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.

Change at Week 6

Group	Value	95% CI
Intervention	3.1	1.7 – 4.5
Control	5.0	3.1 – 6.9

Change at Week 12

Group	Value	95% CI
Intervention	3.2	1.8 – 4.6
Control	5.1	3.2 – 7.0

System Usability Scale (SUS) Secondary · 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.

Group	Value	95% CI
Intervention	72	61 – 75

Safety Event Count Secondary · Week 12

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.

Serious Adverse Events

Group	Value	95% CI
Intervention	0
Control	1

Non-Serious Adverse Events

Group	Value	95% CI
Intervention	11
Control	9

Timed Up-and-Go Test (TUG) Secondary · 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.

Change at Week 6

Group	Value	95% CI
Intervention	-1.7	-2.9 – -0.5
Control	-0.6	-2.3 – 1.0

Change at Week 12

Group	Value	95% CI
Intervention	-1.9	-3.1 – -0.7
Control	-0.6	-2.3 – 1.0

4-Stage Balance Test Secondary · 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. Total scores range from 0 to 40, with higher scores indicating better outcomes.

Change at Week 6

Group	Value	95% CI
Intervention	1.8	-.01 – 3.6
Control	1.6	-0.9 – 4.1

Change at Week 12

Group	Value	95% CI
Intervention	2.9	1.1 – 4.7
Control	2.7	0.3 – 5.2

MRC Dyspnea Secondary · 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

Change at Week 6

Group	Value	95% CI
Intervention	-1.3	-2.0 – -0.7
Control	-1.2	-2.1 – -0.3

Change at Week 12

Group	Value	95% CI
Intervention	-1.5	-2.1 – -0.8
Control	-1.4	-2.2 – -0.5

Activities-Specific Balance Confidence (ABC) Scale Secondary · 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.

Change at Week 6

Group	Value	95% CI
Intervention	7.1	-0.2 – 14.3
Control	11.3	1.6 – 21.1

Change at Week 12

Group	Value	95% CI
Intervention	10.0	2.7 – 17.3
Control	14.2	4.5 – 24.0

Three-Item Loneliness Scale Secondary · 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.

Change at Week 6

Group	Value	95% CI
Intervention	-0.4	-1.1 – 0.3
Control	0.3	-0.6 – 1.2

Change at Week 12

Group	Value	95% CI
Intervention	-0.8	-1.5 – -0.1
Control	-0.1	-1.1 – 0.8

PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a Secondary · 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.

Change at Week 6

Group	Value	95% CI
Intervention	-0.3	-1.9 – 1.3
Control	-0.2	-2.3 – 1.9

Change at Week 12

Group	Value	95% CI
Intervention	0.1	-1.5 – 1.7
Control	0.2	-1.9 – 2.3

PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions Secondary · 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.

Change at Week 6

Group	Value	95% CI
Intervention	2.2	-1.4 – 5.8
Control	2.7	-2.0 – 7.5

Change at Week 12

Group	Value	95% CI
Intervention	3.9	0.2 – 7.5
Control	4.4	-0.4 – 9.2

PROMIS Scale v1.2 Global Health: Secondary · 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.

Change at Week 6

Group	Value	95% CI
Intervention	0.5	-2.8 – 3.8
Control	2.1	-2.3 – 6.5

Change at Week 12

Group	Value	95% CI
Intervention	3.0	-0.3 – 6.3
Control	4.6	0.1 – 9.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 2/29 (7%)

Deaths: 0/29

Control

Serious: 1/15 (7%)

Deaths: 0/15

Serious adverse events (1 terms)

Reaction	System	Intervention	Control
Hospitalization	General disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention	Control
Falls	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Hospitalization.

Data from ClinicalTrials.gov NCT04663945 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety, feasibility and initial efficacy of an app-facilitated telerehabilitation (AFTER) programme for COVID-19 survivors: a pilot randomised study.
   Capin JJ, Jolley SE, Morrow M, Connors M, et al · · 2022 · cited 42× · PMID 35882451 · DOI 10.1136/bmjopen-2022-061285
2. Using Wearable Technology to Quantify Physical Activity Recovery: Secondary Report From the AFTER (App-Facilitated Tele-Rehabilitation) Program for COVID-19 Survivors Randomized Study.
   Churchill L, Morrow M, Capin JJ, Jolley SE, et al · · 2023 · cited 2× · PMID 36939818 · DOI 10.2196/43436