Covid19IMPACCTNCT04979897
Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
An observational study of Covid19 and Critical Care, run by Universidad del Desarrollo at 7 sites in Chile.
Trial summary
Intensive care unit (ICU) survivors and their families frequently present mental, cognitive and physical impairments lasting years. The ongoing pandemic could affect the duration, variety, and severity of these impairments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Critical Care, Postintensive Care Syndrome
- What is being tested?
- Intensive care unit stay during the COVID-19 pandemic
- How many people
- 252 participants
- Where
- 7 sitesChile
- Study dates
- 20 Oct 2020to 2 Sep 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who were mechanically ventilated in the ICU, either with the diagnosis of COVID-19 or other causes
Who may be able to join
- Adult patients (≥18 years old)
- Mechanically ventilated for at least 48 hours
Who cannot join
- Unable to walk independently 2 weeks prior to ICU admission (with or without a gait aid)
- S5q < 5 or CAM-ICU positive within 72 hours after ICU discharge
- Patient who do not understand or speak Spanish
- Patient unable to communicate verbally
- Burn or severe trauma as admission diagnosis
- Any neurological disorder (i.e. spinal cord injury, stroke and brain tumours) as admission diagnosis
- Transferred to a non-participating study centre before ICU discharge assessment
- Recent prolonged hospital stay (extended by more than 3 months)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Chile7 sites
Hospital Regional Dr. Leonardo Guzmán de Antofagasta
Antofagasta
Hospital San Pablo de Coquimbo
Coquimbo
Clínica Alemana de Santiago
Santiago
Clínica BUPA
Santiago
Clínica INDISA
Santiago
Hospital del Salvador
Santiago
Hospital Metropolitano
Santiago
About this study
Official title: Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic (IMPACCT COVID-19): a Prospective, Multicentre, Mixed-methods Cohort Study
Intensive care unit (ICU) survivors and their families frequently present mental, cognitive and physical impairments lasting years. The ongoing pandemic could affect the duration, variety, and severity of these impairments. Our aim is to determine the impact of the COVID-19 pandemic on the physical, mental, and cognitive health of survivors, the experience of their families and their treating healthcare professionals in the long-term.
This is a prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Health care professionals will be invited to discuss the challenges faced during the pandemic using semi-structured interviews.
- Conditions
- Covid19, Critical Care, Postintensive Care Syndrome
- Being tested
- Intensive care unit stay during the COVID-19 pandemic
- Keywords
- Covid19, Critical care, Postintensive Care Syndrome, Rehabilitation, Follow-up
- Medical subject headings
- COVID-19, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive care unit stay during the COVID-19 pandemicOther
Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open [close] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study
| Study group | Role | What they receive |
|---|---|---|
| Intensive care unit stay during high bed occupancy in the COVID-19 pandemic | Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a high bed occupancy in the pandemic Receives: Other: Intensive care unit stay during the COVID-19 pandemic | |
| Intensive care unit stay during low bed occupancy in the COVID-19 pandemic | Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a low bed occupancy in the pandemic Receives: Other: Intensive care unit stay during the COVID-19 pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
The WHODAS 2.0 is a self-reported disability questionnaire based on the International Classification of Functioning, Disability, and Health (ICF). It includes 36 questions, organised under six domains (cognition, mobility, self-care, getting along, life activities and participation). Each question must be answered based on the perceived difficulty for performing activities using a 5-point scale (none, mild, moderate, severe and extreme). The overall score of each domain, it is transformed into a score between 0 and 100, where 0 means no disability and 100 is complete disability
Measured: 6 months after the ICU discharge
Secondary outcomes (9)
Clinical Frailty Scale
The CFS evaluates specific domains including physical functioning, activities of daily living (ADL), instrumental ADL, assistance for personal care, comorbidities, and cognition to generate a frailty score using a 9-point scale ranging from 1 (very fit) to 9 (terminally ill). A score greater than 4 is considered fragile
Measured: Within 72 hours from ICU discharge
Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength
the MRC-SS consists of a standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion). All muscle groups are scored using a 6-point scale between 0 and 5 (0 = no visible /palpable contraction; 1 = visible / palpable contraction or no limb movement; 2 = limb movement, but not against gravity; 3 = movement against the gravity over nearly the entire range of motion; 4 = motion against gravity and resistance, subjectively adjusted for gender and age; 5 = normal force). The score goes from 0 (no strength) to a maximum score of 60 points, indicating normal peripheral strength.
Measured: Within 72 hours from ICU discharge
Functional Status Score for the Intensive Care Unit (FSS-ICU)
The FSS-ICU is a mobility instrument to score the level of physical assistance required when performing five functional activities: rolling, transfer from supine to sit, sitting at the edge of the bed, transfer from sitting to stand, and walking. Each activity is scored using a 7-point scale ranging from 0 (not able to perform) to 7 (complete independence). The resulting overall score ranges from 0 to 35 points, where a higher scores indicates better performance.
Measured: Within 72 hours from ICU discharge
Montreal Cognitive Assessment-Blind (MoCA Blind)
The MoCA blind is a cognitive screening tool designed to detect cognitive dysfunction in five areas: memory, attention, language, abstraction and orientation. Each domain is scored separately for a total score ranging from 0 to 22 points. A score equal to or greater than 18 points is considered normal cognition.
Measured: 6 months after the ICU discharge
Hospital Anxiety and Depression Scale (HADS)
The HADS is an interviewer or self-administered questionnaire designed to identify anxiety and depressive symptoms in a wide variety of in-hospital patients, which requires between 2 and 5 minutes to be completed. The HADS has fourteen questions, seven for anxiety and seven for depressive symptoms. Each question is rated with a 4-point scale ranging from 0 ("absence") to 3 ("extreme presence"), resulting in a sum score of 21 points per subscale. For each subscale, a score >8 indicates suspected anxiety or depression, while a score >11 indicates clinical symptoms of anxiety or depression.
Measured: 6 months after the ICU discharge
Impact of Events Scale-Revised (IES-R)
The IES-R is an interviewer or self-administered questionnaire designed to measure the subjective distress caused by traumatic events that has been validated for critical illness survivors. It comprises 22 questions in three subscales: intrusion, avoidance, and hyperarousal. Questions are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The score goes from 0 to 88 points. Scores above 33 are indicative of post-traumatic stress symptoms.
Measured: 6 months after the ICU discharge
European Quality of Life Health Questionnaire (EQ-5D-3L)
The EQ-5D-3L is an interviewer or self-administered questionnaire of health status or health-related quality of life, including five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and global health state. Each domain is scored based on 3 levels of severity: no problems, some problems, and extreme problems. Each combination of answers can be translated into a utility score, where 0 is similar to being dead and 1 represents the best possible quality of life. The utility scores were obtained using the Chilean Social valuation of EQ-5D health states (DOI: http://dx.doi.org/10.1016/j.jval.2011.09.002)
Measured: 6 months after the ICU discharge
Employment Status
The employment status was evaluated using the following questions: What is your current employment status? What working hours do you have? and has your employment situation changed after your ICU stay?
Measured: 6 months after the ICU discharge
Survival
Number of patients who survived
Measured: 6 months after the ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start20 Oct 2020
- Primary completion2 Nov 2021
- Study completion2 Sep 2022
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Alemana de Santiago, Clinica Indisa, Clinica Bupa Santiago, Hospital del Salvador, Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman, Hospital San Pablo de Coquimbo, Hospital Metropolitano
- Responsible party
- Principal investigator, Ana Cristina Castro, Universidad del Desarrollo
- Investigators
- Ana Castro-Ávila, PhD, Principal investigator, Universidad del Desarrollo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979897
- Sponsor's protocol ID
- 2020-78
- Acronym
- IMPACCT
- Status last verified
- Jun 2024
- First submitted
- 24 Jul 2021
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Castro-Avila A, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Munoz-Munoz F, Leppe J; IMPACCT COVID-19 study group. Six-month post-intensive care outcomes during high and low bed occupancy due to the COVID-19 pandemic: A multicenter prospective cohort study. PLoS One. 2023 Nov 16;18(11):e0294631. doi: 10.1371/journal.pone.0294631. eCollection 2023.
PubMed 37972091Castro-Avila AC, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Leppe J; IMPACCT COVID-19 study group. Impact on Mental, Physical and Cognitive functioning of a Critical care sTay during the COVID-19 pandemic (IMPACCT COVID-19): protocol for a prospective, multicentre, mixed-methods cohort study. BMJ Open. 2021 Sep 8;11(9):e053610. doi: 10.1136/bmjopen-2021-053610.
PubMed 34497087
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic (IMPACCT COVID-19): a Prospective, Multicentre, Mixed-methods Cohort Study
- ClinicalTrials.gov ID
- NCT04979897
- Acronym / sponsor ID
- IMPACCT / 2020-78
- Conditions
- Covid19, Critical Care, Postintensive Care Syndrome
- Keywords
- Covid19, Critical care, Postintensive Care Syndrome, Rehabilitation, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Clinica Alemana de Santiago, Clinica Indisa, Clinica Bupa Santiago, Hospital del Salvador, Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman, Hospital San Pablo de Coquimbo, Hospital Metropolitano
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 12 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intensive care unit (ICU) survivors and their families frequently present mental, cognitive and physical impairments lasting years. The ongoing pandemic could affect the duration, variety, and severity of these impairments. Our aim is to determine the impact of the COVID-19 pandemic on the physical, mental, and cognitive health of survivors, the experience of their families and their treating healthcare professionals in the long-term.
This is a prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Health care professionals will be invited to discuss the challenges faced during the pandemic using semi-structured interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit stay during high bed occupancy in the COVID-19 pandemic | – | Other: Intensive care unit stay during the COVID-19 pandemicAdult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a high bed occupancy in the pandemic |
| Intensive care unit stay during low bed occupancy in the COVID-19 pandemic | – | Other: Intensive care unit stay during the COVID-19 pandemicAdult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a low bed occupancy in the pandemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who were mechanically ventilated in the ICU, either with the diagnosis of COVID-19 or other causes
Key inclusion criteria (2 listed)
- Adult patients (≥18 years old)
- Mechanically ventilated for at least 48 hours
Key exclusion criteria (8 listed)
- Unable to walk independently 2 weeks prior to ICU admission (with or without a gait aid)
- S5q < 5 or CAM-ICU positive within 72 hours after ICU discharge
- Patient who do not understand or speak Spanish
- Patient unable to communicate verbally
- Burn or severe trauma as admission diagnosis
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 |
|---|---|---|
| Intensive care unit stay during the COVID-19 pandemicPatients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open [close] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study | Other | Intensive care unit stay during high bed occupancy in the COVID-19 pandemic, Intensive care unit stay during low bed occupancy in the COVID-19 pandemic |
Primary outcome
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 6 months after the ICU discharge
The WHODAS 2.0 is a self-reported disability questionnaire based on the International Classification of Functioning, Disability, and Health (ICF). It includes 36 questions, organised under six domains (cognition, mobility, self-care, getting along, life activities and participation). Each question must be answered based on the perceived difficulty for performing activities using a 5-point scale (none, mild, moderate, severe and extreme). The overall score of each domain, it is transformed into a score between 0 and 100, where 0 means no disability and 100 is complete disability
9 secondary outcomes
Clinical Frailty Scale
Time frame: Within 72 hours from ICU discharge
Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength
Time frame: Within 72 hours from ICU discharge
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Time frame: Within 72 hours from ICU discharge
Montreal Cognitive Assessment-Blind (MoCA Blind)
Time frame: 6 months after the ICU discharge
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months after the ICU discharge
Impact of Events Scale-Revised (IES-R)
Time frame: 6 months after the ICU discharge
European Quality of Life Health Questionnaire (EQ-5D-3L)
Time frame: 6 months after the ICU discharge
Employment Status
Time frame: 6 months after the ICU discharge
Survival
Time frame: 6 months after the ICU discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37972091Castro-Avila A, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Munoz-Munoz F, Leppe J; IMPACCT COVID-19 study group. Six-month post-intensive care outcomes during high and low bed occupancy due to the COVID-19 pandemic: A multicenter prospective cohort study. PLoS One. 2023 Nov 16;18(11):e0294631. doi: 10.1371/journal.pone.0294631. eCollection 2023.
- Derived from this study: PubMed 34497087Castro-Avila AC, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Leppe J; IMPACCT COVID-19 study group. Impact on Mental, Physical and Cognitive functioning of a Critical care sTay during the COVID-19 pandemic (IMPACCT COVID-19): protocol for a prospective, multicentre, mixed-methods cohort study. BMJ Open. 2021 Sep 8;11(9):e053610. doi: 10.1136/bmjopen-2021-053610.
- Custom-made study web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Ana Castro-Ávila, PhD principal investigator
Universidad del Desarrollo
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Critical Care, run by Universidad del Desarrollo at 7 sites 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 2 inclusion and 8 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 12 Jul 2024). 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?
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) (time frame: 6 months after the ICU discharge). 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 NCT04979897, 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 12 Jul 2024.