Clinical trial NCT04394169: Early Care Program for the Management of Post-ICU Syndrome and Chronic Pain After COVID-19 Infection.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post ICU Syndrome
Chronic Pain
Covid-19
Keywords: Covid-19
SARS-COV2
Critical Care
Post ICU Syndrome
Chronic Pain
Post-traumatic Stress Disorder
Quality of Life
Depressive Disorders
Anxiety disorders
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, single-blind, and single-center clinical trial that will include patients who have been admitted to intensive care of our hospital due to COVID-19 disease.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of intervention program on health-related quality of life (VAS)
timeFrame: Six months after discharge
Secondary outcomes:
measure: Impact of intervention program on health-related quality of life (VAS)
timeFrame: Three months after discharge.
measure: Impact of intervention program on health-related quality of life (Index)
timeFrame: Three months after discharge
measure: Impact of intervention program on health-related quality of life (Index)
timeFrame: Six months after discharge
measure: Impact of intervention program on chronic pain (intensity)
timeFrame: Three and six months after discharge.
measure: Impact of intervention program on chronic pain (limitation of daily activities)
timeFrame: Three and six months after discharge.
measure: Impact of intervention program on chronic pain (Pain catastrophization)
timeFrame: Three and six months after discharge.
measure: Impact of intervention program on anxiety or depression incidence
timeFrame: Three and six months after discharge.
measure: Impact of intervention on probable post-traumatic stress syndrome incidence
timeFrame: Three and six months after discharge.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Tomás Cuñat
Study officials:
affiliation: Pain unit physician
name: Antonio José Ojeda Niño, MD
role: PRINCIPAL_INVESTIGATOR
References:
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