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Early Care Program for the Management of Post-ICU Syndrome and Chronic Pain After COVID-19 Infection.

CompletedNot applicableNCT04394169
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

COVID-19 (coronavirus 2019) disease has led to a large number of hospital admissions, many of which require admission to intensive care (ICU). Post-intensive care syndrome (PICS) is defined as deterioration or worsening of previous deterioration in the mental, physical or cognitive status that appears as a consequence of a critical illness and which persists after acute hospital care. Also, there is evidence that patients who survive a critical illness have a high prevalence of moderate to extreme chronic pain. Patients with COVID-19 disease are an especially susceptible population to develop PICS due to acute respiratory distress syndrome (ARDS) survivors have significant long-term deterioration in mental, cognitive, and functional health. This study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease.

Study details

Official title
Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 Infection. Simple-blind, Controlled, Randomized Trial.
Conditions
Interventions
  • Behavioral: Intervention program
Sponsor
Hospital Clinic of Barcelona
Start date
2020-05-25
Primary completion
2021-10-15
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Spain
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Admitted to the ICU due to COVID infection19. * APACHE II score\> 14 or ICU stay\> 10 days or Duration of mechanical ventilation\> 7 days or Acquired weakness in ICU or Delirium during ICU admission. * Accept to participate in the study and sign informed consent. Exclusion Criteria: * Central Nervous System degenerative diseases. Examples: Alzheimer's disease, Amyotrophic lateral sclerosis, Lewy body dementia, Parkinson's disease, among others. * Terminal illness: Definition according to the palliative care guide, Spanish Society for Palliative Care. "Advanced, progressive, and incurable disease with a lack of reasonable possibilities of specific treatment, with a life prognosis of less than 6 months. * Insufficient understanding of the Spanish language. * Patients in whom it would be difficult to complete follow-up. * Not having informed consent.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04394169