Early Care Program for the Management of Post-ICU Syndrome and Chronic Pain After COVID-19 Infection.
NCT ID: NCT04394169
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2020-05-25
2021-10-22
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
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.
Study Groups
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Intervention arm
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.
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.
Standard care arm
Standard medical practice: patient follow-up is carried out by their referring physicians (primary care physicians or specialists) who are outside the study.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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TOMAS MIGUEL CUÑAT LOPEZ
Collaborator Investigator
Principal Investigators
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Antonio José Ojeda Niño, MD
Role: PRINCIPAL_INVESTIGATOR
Pain unit physician
Locations
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Tomás Cuñat
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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 Sep 23:501915. doi: 10.1016/j.redare.2025.501915. Online ahead of print.
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.
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.
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.
Other Identifiers
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HCB/2020/0549
Identifier Type: -
Identifier Source: org_study_id