Covid-19AFTERNCT04663945
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
A study testing Biobehavioral Tele-rehabilitation Sessions in people with Covid-19 and Deconditioning, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Covid-19, Deconditioning
- What is being tested?
- Biobehavioral Tele-rehabilitation Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2020to 27 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid-19, Deconditioning
- Being tested
- Biobehavioral Tele-rehabilitation Sessions
- Keywords
- Tele-rehabilitation, High Intensity, Biobehavioral, Activity Self-Monitoring, Physical Functional Performance
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobehavioral Tele-rehabilitation SessionsBehavioural
Biobehavioral tele-rehabilitation sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: Biobehavioral Tele-rehabilitation Sessions |
| Control | No intervention | This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training. Other: basic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start11 Dec 2020
- Primary completion12 Aug 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kristine Erlandson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663945
- Sponsor's protocol ID
- 20-2415
- Acronym
- AFTER
- Status last verified
- Oct 2022
- First submitted
- 8 Dec 2020
- Last updated
- 4 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36939818Capin 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.
PubMed 35882451
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID Survivors
- ClinicalTrials.gov ID
- NCT04663945
- Acronym / sponsor ID
- AFTER / 20-2415
- Conditions
- Covid-19, Deconditioning
- Keywords
- Tele-rehabilitation, High Intensity, Biobehavioral, Activity Self-Monitoring, Physical Functional Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Posted 4 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Biobehavioral Tele-rehabilitation SessionsThis 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 intervention | –This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training. Other: basic education |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobehavioral Tele-rehabilitation SessionsBiobehavioral tele-rehabilitation sessions | Behavioural | Intervention |
Primary outcome
Adherence (Primary Feasibility/Safety Outcome)
Time frame: 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.
Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
Time frame: 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.
14 secondary outcomes
System Usability Scale (SUS)
Time frame: 6 weeks (primary end point)
Safety Event Count
Time frame: Week 12
Timed Up-and-Go Test (TUG)
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
4-Stage Balance Test
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
MRC Dyspnea
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Activities-Specific Balance Confidence (ABC) Scale
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Three-Item Loneliness Scale
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
PROMIS Scale v1.2 Global Health:
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Montreal Cognitive Assessment (MoCA)-BLIND
Time frame: Change from Baseline to week 12
Clinical Frailty Scale
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Average Daily Step Count
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Patient Health Questionnaire 8 (PHQ8)
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36939818Churchill 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.
- Derived from this study: PubMed 35882451Capin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Erlandson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biobehavioral Tele-rehabilitation Sessions in people with Covid-19 and Deconditioning, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (Primary Feasibility/Safety Outcome) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663945, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.