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NCT Number: NCT04979897

Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional Dr. Leonardo Guzmán de Antofagasta, Antofagasta, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years old)
  • Mechanically ventilated for at least 48 hours

Exclusion criteria

  • 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)

Treatment and study plan

Intensive care unit stay during the COVID-19 pandemic

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Clinical Frailty Scale

    Time frame: Within 72 hours from ICU discharge

    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

  2. Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength

    Time frame: Within 72 hours from ICU discharge

    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.

  3. Functional Status Score for the Intensive Care Unit (FSS-ICU)

    Time frame: Within 72 hours from ICU discharge

    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.

  4. Montreal Cognitive Assessment-Blind (MoCA Blind)

    Time frame: 6 months after the ICU discharge

    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.

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6 months after the ICU discharge

    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.

  6. Impact of Events Scale-Revised (IES-R)

    Time frame: 6 months after the ICU discharge

    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.

  7. European Quality of Life Health Questionnaire (EQ-5D-3L)

    Time frame: 6 months after the ICU discharge

    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)

  8. Employment Status

    Time frame: 6 months after the ICU discharge

    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?

  9. Survival

    Time frame: 6 months after the ICU discharge

    Number of patients who survived

Other outcomes

  1. Cohort Retention Rate

    Time frame: Every month during one year

    Number of patients who can be contacted and evaluated

Sponsors and collaborators

Lead sponsor

Universidad del Desarrollo

Other

Collaborators

  • Clinica Alemana de Santiago
  • Clinica Bupa Santiago
  • Clinica Indisa
  • Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman
  • Hospital Metropolitano
  • Hospital San Pablo de Coquimbo
  • Hospital del Salvador

Registry information

Official study 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

Acronym: IMPACCT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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