Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04394169
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2020-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Care Program for the Management of Post-ICU Syndrome and Chronic Pain After COVID-19 Infection.
Sponsor:
Hospital Clinic of Barcelona
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAIN-COVID
Brief 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.
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.
Detailed Description:
A randomized, controlled, and single-blind trial will be performed. Patients over 18 years who have been admitted to intensive care units with the diagnosis of COVID-19 disease at risk of presenting PICS will be recruited.
The study subjects will be divided into two arms, and the intervention program will be compared to the standard care clinical practice.
The program will consist of early care (first visit at one month of hospital discharge), therapeutic education on prevention and management of PICS and chronic pain during three medical visits in six months, and psychological treatment in patients at risk for emotional distress.
The main objective is to evaluate the impact of the program on health-related life quality at six months after hospital discharge.
The secondary objectives are:
1. To assess the health-related life quality at three months after hospital discharge.
2. To quantify the incidence of chronic pain, its characteristics, and the degree of functional limitation at three and six months after hospital discharge.
3. To quantify the incidence of anxiety and depression at three and six months after hospital discharge.
4. Quantify the incidence of post-traumatic stress syndrome at 3 and 6 months after hospital discharge.
The study subjects will be divided into two arms, and the intervention program will be compared to the standard care clinical practice.
The program will consist of early care (first visit at one month of hospital discharge), therapeutic education on prevention and management of PICS and chronic pain during three medical visits in six months, and psychological treatment in patients at risk for emotional distress.
The main objective is to evaluate the impact of the program on health-related life quality at six months after hospital discharge.
The secondary objectives are:
1. To assess the health-related life quality at three months after hospital discharge.
2. To quantify the incidence of chronic pain, its characteristics, and the degree of functional limitation at three and six months after hospital discharge.
3. To quantify the incidence of anxiety and depression at three and six months after hospital discharge.
4. Quantify the incidence of post-traumatic stress syndrome at 3 and 6 months after hospital discharge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: