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

Hospital Clinic of Barcelona

Status: Completed

Conditions: Chronic Pain; Post ICU Syndrome; Covid-19

Treatments: Behavioral: Intervention program

Study type: Interventional

Funder types: Other

Identifiers

NCT04394169

HCB/2020/0549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Intervention arm

Experimental group

Description:

The intervention is a program that includes early patient care, therapeutic education, and psychological intervention. It will be performed through three medical visits and a psychological intervention that requires seven face-to-face sessions.

Treatment:

Behavioral: Intervention program

Standard care arm

No Intervention group

Description:

Standard medical practice: patient follow-up is carried out by their referring physicians (primary care physicians or specialists) who are outside the study.