Covid19NCT04904497
Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19
A study testing Early Occupational Therapy in people with Covid19 and Critical Illness, run by University of Chile at 1 site in Chile.
Trial summary
This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Critical Illness, Impairment, Cognitive
- What is being tested?
- Early Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years.
- Need for hospitalization in ICU.
- At least 12 h of invasive mechanical ventilation
- Informed consent signed by legal representative and / or patient.
- Positive covid-19 diagnosis
Who cannot join
- Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores> 3.3 were excluded.
- Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as > 6 points.
- Severe communication disorder and cultural limitation of language (language different from Spanish)
- Patient with limited therapeutic proportionality.
- Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
- Spinal injury or unstable fractures that limit mobilization
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
University of Chile
Santiago, Santiago Metropolitan
Eduardo Tobar, MD, +56229786009, etobar@hcuch.cl
Eduardo Tobar, MD
About this study
Official title: Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19: Multicentre Pilot Randomized Clinical Trial
This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19.
Read the detailed description
A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.
A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early OT plus ASDM.
The intervention group will receive 20 OT sessions, which considers a predefined protocol of actions according to the patient's condition
- Being tested
- Early Occupational Therapy
- Medical subject headings
- COVID-19, Critical Illness, Cognitive Dysfunction, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Occupational TherapyBehavioural
Occupational therapists will implement the following activities:
- Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 2 one session each 24 h.
- Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS <2, 6> environmental orientation will be considered
- Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5
- Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas
- Education: trained family members and health staff about the intervention process
| Study group | Role | What they receive |
|---|---|---|
| Early Occupational Therapy | Experimental | These sessions will be implemented by occupational therapists trained in ICU, who will conduct 20 sessions of 30 min, distributed depending on the level of sedation, i) SAS (Sedation-Agitation Scale) 1 patients have one session each 48 h, evaluating the change of sedation level each 24 h; ii) SAS 2 patients have one session each 24 h, iii) SAS 3-5 have two sessions every day. The sessions will begin once the patient needs mechanical ventilation for at least 12 h Receives: Behavioral: Early Occupational Therapy |
| Standard | No intervention | The ASDM protocol will be implemented to mechanically ventilated patients in the ICU, following the aspects recommended by experts and the current evidence. For this, the team of medical, nurses, and physiotherapist will be trained to understand and facilitate the ASDM actions that each one must implement. Occupational Therapy interventions for control group will be allowed for this group only before 1 week after the first day on light sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence at hospital discharge
The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Secondary outcomes (8)
Delirium-free days
CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluatorhigher score is better, which will be compared between control and experimental group
Measured: Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
Coma-free days
SAS (Sedation-Agitation Scale) instrument will be applied once a day by evaluator. If SAS 1-2: coma day
Measured: Defined as the number of days in the first 14 days with the SAS.
Delirium-coma free days
SAS and CAM-ICU instruments will be applied once a day by evaluator. Every day without coma or delirium its an delirium-coma free day
Measured: Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Functional independence at hospital discharge
The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Cognitive status of patients
MoCA (Montreal Cognitive Assessment) instrument (cognitive status).This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Motor status of patients
Grip strength (motor status) with dynamometer will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Quality of life of patients
EQ-5D-5L (Euro Qol 5 dimensions 5 level) will be applied by evaluator. It will be considered a cut-off point in the Chilean population
Measured: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Characterization of occupational therapy interventions
Number of sessions implemented, number of sessions suspended
Measured: Days of patient hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Apr 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Model description
- A control group (standard ASDM measures) or an intervention group (early and intensive occupational therapy + ASDM) will be randomized. The intervention group will receive 20 occupational therapy sessions. The interventions will be organized on the basis of i) level of sedation, ii) presence or absence of delirium (according to CAM ICU +/- (Confusion Assessment Method Intensive Care Unit)), iii) movement with or without gravity (cut-off point 3 points in elbow flexion movement in Medical Research Council(MRC)). The areas of intervention implemented by occupational therapist will be: i) Polysensory stimulation, ii) Cognitive stimulation, iii) Basic activities of daily living, iv) Motor function stimulation, v) Education
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse
- Responsible party
- Principal investigator, Eduardo Tobar, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904497
- Sponsor's protocol ID
- Reh-Covid-19
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Occupational Therapy in Mechanical Ventilated Patients With Covid-19: Multicentre Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04904497
- Acronym / sponsor ID
- Reh-Covid-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the feasibility of an early occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation with Covid-19.
Detailed description
A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.
A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early OT plus ASDM.
The intervention group will receive 20 OT sessions, which considers a predefined protocol of actions according to the patient's condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A control group (standard ASDM measures) or an intervention group (early and intensive occupational therapy + ASDM) will be randomized. The intervention group will receive 20 occupational therapy sessions. The interventions will be organized on the basis of i) level of sedation, ii) presence or absence of delirium (according to CAM ICU +/- (Confusion Assessment Method Intensive Care Unit)), iii) movement with or without gravity (cut-off point 3 points in elbow flexion movement in Medical Research Council(MRC)). The areas of intervention implemented by occupational therapist will be: i) Polysensory stimulation, ii) Cognitive stimulation, iii) Basic activities of daily living, iv) Motor function stimulation, v) Education
| Arm | Type | Receives |
|---|---|---|
| Early Occupational Therapy | Experimental | Behavioral: Early Occupational TherapyThese sessions will be implemented by occupational therapists trained in ICU, who will conduct 20 sessions of 30 min, distributed depending on the level of sedation, i) SAS (Sedation-Agitation Scale) 1 patients have one session each 48 h, evaluating the change of sedation level each 24 h; ii) SAS 2 patients have one session each 24 h, iii) SAS 3-5 have two sessions every day. The sessions will begin once the patient needs mechanical ventilation for at least 12 h |
| Standard | No intervention | –The ASDM protocol will be implemented to mechanically ventilated patients in the ICU, following the aspects recommended by experts and the current evidence. For this, the team of medical, nurses, and physiotherapist will be trained to understand and facilitate the ASDM actions that each one must implement. Occupational Therapy interventions for control group will be allowed for this group only before 1 week after the first day on light sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or greater than 18 years.
- Need for hospitalization in ICU.
- At least 12 h of invasive mechanical ventilation
- Informed consent signed by legal representative and / or patient.
- Positive covid-19 diagnosis
Key exclusion criteria (6 listed)
- Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores> 3.3 were excluded.
- Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as > 6 points.
- Severe communication disorder and cultural limitation of language (language different from Spanish)
- Patient with limited therapeutic proportionality.
- Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
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 |
|---|---|---|
| Early Occupational TherapyOccupational therapists will implement the following activities: * Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 2 one session each 24 h. * Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS <2, 6> environmental orientation will be considered * Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5 * Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas * Education: trained family members and health staff about the intervention process | Behavioural | Early Occupational Therapy |
Primary outcome
Functional independence at hospital discharge
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group
8 secondary outcomes
Delirium-free days
Time frame: Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
Coma-free days
Time frame: Defined as the number of days in the first 14 days with the SAS.
Delirium-coma free days
Time frame: Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Functional independence at hospital discharge
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Cognitive status of patients
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Motor status of patients
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Quality of life of patients
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Characterization of occupational therapy interventions
Time frame: Days of patient hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Occupational Therapy in people with Covid19 and Critical Illness, run by University of Chile at 1 site in Chile.
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 6 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: status not confirmed, as of the sponsor's last update on 27 May 2021. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Tobar, MD (+56229786009, etobar@hcuch.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at hospital discharge (time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2021.