COVID-19 Follow up Intensive Care Studies

NCT04460170 | Unknown

• 1 other identifier: COFICS201800422
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Since the SARS-CoV-2 infection is relatively new, the long term attributable burden related to COVID19 has not been investigated yet. To date, in patients with COVID-19 and their family members, there is little information on the functional status, cognitive ability, pattern of return to work, and health related quality of life after the ICU admission. This study aims to describe the psychological wellbeing, physical - and social functioning of COVID-19 ICU survivors and their family members up to 12 months following ICU discharge.

Conditions

Quality of Life; COVID-19

Keywords

Critical Care; Family Members; Patients; Follow-Up Studies; Quality of Life; COVID-19

Outcome Measures

Primary Outcomes (16)

• General Health

  MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain. The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.

  3 months post ICU discharge

• General Health

  MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain. The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.

  6 months post ICU discharge

• General Health

  MOS Short-Form General Health Survey (SF-20). The SF-20 contains 20 items and has six dimensions; physical functioning (min. score 6, max. score 12) rolefunctioning (min. score 2, max. score 4) social functioning (min. score 1, max. score 6) mental health (min. score 5, max. score 30) general health (min. score 5, max. score 25) pain (min. score 1, max score 5) All endscores will be transformed to a 100 points scale where a higher score means better functioning. Except for pain where a higher score means more pain. The five mental health questions will be excluded from our questionnaire because the questions are comparable with the HADS.

  12 months post ICU discharge

• Anxiety and Depression

  Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.

  3 months post ICU discharge

• Anxiety and Depression

  Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.

  6 months post ICU discharge

• Anxiety and Depression

  Hospital Anxiety and Depression Scale (HADS). The HADS contains two subscale of 7 items each. Minimal score is 0, maximal score 21 for each subscale where a higher score means a higher burden.

  12 months post ICU discharge

• Long function

  Spirometry test

  6 months post ICU discharge (only in patients)

• Long function

  Spirometry test

  12 months post ICU discharge (only in patients)

• Frailty

  Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.

  3 months post ICU discharge (only in patients)

• Frailty

  Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.

  6 months post ICU discharge (only in patients)

• Frailty

  Clinical Frailty Scale with a single outcome measure summarizing the overall level of fitness.

  12 months post ICU discharge (only in patients)

• Family functioning

  McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.

  6 months post ICU discharge

• Family functioning

  McMaster Family Assessment Device (FAD-GF6+). The FAD-GF6+ contains 6 items (min. score 6, max. score 24) where a higher scores indicate a lower caregiver burden.

  12 months post ICU discharge

• Effect of an ICU admission on return to work

  Return to work knowing; possible job loss, change of work activities and worsening employment status

  3 months post ICU discharge (only in family members)

• Effect of an ICU admission on return to work

  Return to work knowing; possible job loss, change of work activities and worsening employment status

  6 months post ICU discharge

• Effect of an ICU admission on return to work

  Return to work knowing; possible job loss, change of work activities and worsening employment status

  12 months post ICU discharge

Secondary Outcomes (32)

• age

  24 hours (patient) / 3 months post ICU discharge (family member)

• Gender

  24 hours (patient) / 3 months post ICU discharge (family member)

• Social status

  3 months post ICU discharge

• APACHE IV

  24 hours (only in patients)

• Comorbidity

  3 months post ICU discharge (only in patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of all admitted critically ill COVID-19 patients with a \> 48 hours ICU admission at the ICU of a University Medical Center and a family member of the patient. Family members in this study can be partners, other family members, or friends who are identified by the patient as important.

You may qualify if:

• ≥ 18 years old
• Ability to speak and write Dutch
• Ability to conduct a telephone call
• Diagnosed with COVID-19 infection (only in patients)
• hours ICU admission (only in patients)

You may not qualify if:

• Refuse to participate
• Serious language barrier
• Cognitive impairment
• Severe psychiatric disorder
• Chronic ventilator dependency (only in patients)

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Hanze University of Applied Sciences Groningen: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

I van der Meulen, PhD

CONTACT

+31503615617; i.c.van.der.meulen@pl.hanze.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

NL (1)