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

NCT04394169 | Completed

• 1 other identifier: HCB/2020/0549
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Impact of intervention program on health-related quality of life (VAS)

  Health-related quality of life reported by the patient assessed through the visual analogue scale of the EQoL 5D/5L questionnaire at six months after discharge. \[European quality of life 5 dimensions/5 levels ; from 0 (the worst imaginable health) to 100 (the best imaginable health) \]

  Six months after discharge

Secondary Outcomes (8)

• Impact of intervention program on health-related quality of life (VAS)

  Three months after discharge.

• Impact of intervention program on health-related quality of life (Index)

  Three months after discharge

• Impact of intervention program on health-related quality of life (Index)

  Six months after discharge

• Impact of intervention program on chronic pain (intensity)

  Three and six months after discharge.

• Impact of intervention program on chronic pain (limitation of daily activities)

  Three and six months after discharge.

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Behavioral: Intervention program

Standard care arm

NO INTERVENTION

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

Interventions

Intervention program BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Tomás Cuñat

Barcelona, 08036, Spain

Location

Related Publications (12)

• Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

  PMID: 32105632 BACKGROUND

• Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.

  PMID: 32275288 BACKGROUND

• Boldrini P, Bernetti A, Fiore P; SIMFER Executive Committee, SIMFER Committee for International Affairs. Impact of COVID-19 outbreak on rehabilitation services and Physical and Rehabilitation Medicine physicians' activities in Italy. An official document of the Italian PRM Society (SIMFER). Eur J Phys Rehabil Med. 2020 Jun;56(3):316-318. doi: 10.23736/S1973-9087.20.06256-5. Epub 2020 Mar 16. No abstract available.

  PMID: 32175719 BACKGROUND

• Griffiths J, Hatch RA, Bishop J, Morgan K, Jenkinson C, Cuthbertson BH, Brett SJ. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care. 2013 May 28;17(3):R100. doi: 10.1186/cc12745.

  PMID: 23714692 BACKGROUND

• Torres J, Carvalho D, Molinos E, Vales C, Ferreira A, Dias CC, Araujo R, Gomes E. The impact of the patient post-intensive care syndrome components upon caregiver burden. Med Intensiva. 2017 Nov;41(8):454-460. doi: 10.1016/j.medin.2016.12.005. Epub 2017 Feb 8. English, Spanish.

  PMID: 28188064 BACKGROUND

• Elliott D, Davidson JE, Harvey MA, Bemis-Dougherty A, Hopkins RO, Iwashyna TJ, Wagner J, Weinert C, Wunsch H, Bienvenu OJ, Black G, Brady S, Brodsky MB, Deutschman C, Doepp D, Flatley C, Fosnight S, Gittler M, Gomez BT, Hyzy R, Louis D, Mandel R, Maxwell C, Muldoon SR, Perme CS, Reilly C, Robinson MR, Rubin E, Schmidt DM, Schuller J, Scruth E, Siegal E, Spill GR, Sprenger S, Straumanis JP, Sutton P, Swoboda SM, Twaddle ML, Needham DM. Exploring the scope of post-intensive care syndrome therapy and care: engagement of non-critical care providers and survivors in a second stakeholders meeting. Crit Care Med. 2014 Dec;42(12):2518-26. doi: 10.1097/CCM.0000000000000525.

  PMID: 25083984 BACKGROUND

• Hayhurst CJ, Jackson JC, Archer KR, Thompson JL, Chandrasekhar R, Hughes CG. Pain and Its Long-term Interference of Daily Life After Critical Illness. Anesth Analg. 2018 Sep;127(3):690-697. doi: 10.1213/ANE.0000000000003358.

  PMID: 29649027 BACKGROUND

• Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.

  PMID: 23718685 BACKGROUND

• Ojeda A, Cunat T, Comino-Trinidad O, Aliaga J, Arias M, Calvo A. New-onset chronic and neuropathic pain in survivors of severe COVID-19: A secondary analysis of the PAIN-COVID Trial. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Dec;72(10):501915. doi: 10.1016/j.redare.2025.501915. Epub 2025 Sep 23.

  PMID: 40998165 DERIVED

• Ojeda A, Calvo A, Cunat T, Mellado-Artigas R, Costas-Carrera A, Sanchez-Rodriguez MM, Comino-Trinidad O, Aliaga J, Arias M, Martinez-Palli G, Dursteler C, Ferrando C. Effectiveness of a specific follow up program for the management of the mental components of post-intensive care syndrome and chronic pain after COVID-19: results from the PAIN-COVID randomized clinical trial. Rev Esp Anestesiol Reanim (Engl Ed). 2024 May;71(5):349-359. doi: 10.1016/j.redare.2023.12.009. Epub 2024 Jan 17.

  PMID: 38242358 DERIVED

• Ojeda A, Calvo A, Cunat T, Mellado-Artigas R, Comino-Trinidad O, Aliaga J, Arias M, Ferrando C, Martinez-Palli G, Dursteler C. Characteristics and influence on quality of life of new-onset pain in critical COVID-19 survivors. Eur J Pain. 2022 Mar;26(3):680-694. doi: 10.1002/ejp.1897. Epub 2021 Dec 15.

  PMID: 34866276 DERIVED

• Ojeda A, Calvo A, Cunat T, Artigas RM, Comino-Trinidad O, Aliaga J, Arias M, Ahuir M, Ferrando C, Dursteler C. Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial. Trials. 2021 Jul 24;22(1):486. doi: 10.1186/s13063-021-05463-7.

  PMID: 34303381 DERIVED

MeSH Terms

Conditions

Chronic Pain; COVID-19; Stress Disorders, Post-Traumatic; Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Mood Disorders

Study Officials

• Antonio José Ojeda Niño, MD

  Pain unit physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Visits 1,2, and 3 will be carried out by an investigator with sufficient training in questionnaires. This investigator will not participate on the intervention or the evaluation of the results. The intervention will be performed by two researchers (Pain Physician and psychologist). This researcher will not participate in the questionnaire and basal data collection visits or results analysis. Researchers who analyze the results will not participate in the questionnaire and basal data collection or program intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: May 25, 2020
• Primary Completion: October 15, 2021
• Study Completion: October 22, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)