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

NCT04394169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-12-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Intervention program

Medical visits: There will be three medical visits stipulated as follows: * Visit 1 Intervention Group, four weeks after hospital discharge. * Visit 2 Intervention Group, eight weeks after hospital discharge. * Visit 3 Intervention Group, 18 weeks after hospital discharge. Components of visits: * Interview and physical examination. * Therapeutic education about the intensive care syndrome orally and with a specific document that will be delivered at the end of the visit. * Therapeutic education around pain. If the patient reports pain, a specific document will be prepared that will be delivered at the end of the visit. Psychological intervention: Inclusion criteria for psychological intervention: Patients with a score higher than 8 on the HAD (hospital anxiety and depression) test depression subscale. Description : The intervention protocol consists of 7 weekly sessions lasting one hour and a half. The intervention in depression is based on Rehm's model of self-control.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Antonio José Ojeda Niño, MD · Pain unit physician

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2021-10-15
Completion
2021-10-22

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394169 on ClinicalTrials.gov