Early Care Program for the Management of Post-ICU Syndrome and Chronic Pain After COVID-19 Infection. (PAIN-COVID)
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| ClinicalTrials.gov Identifier: NCT04394169 |
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Recruitment Status :
Completed
First Posted : May 19, 2020
Last Update Posted : December 14, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post ICU Syndrome Chronic Pain Covid-19 | Behavioral: Intervention program | Not Applicable |
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:
- To assess the health-related life quality at three months after hospital discharge.
- To quantify the incidence of chronic pain, its characteristics, and the degree of functional limitation at three and six months after hospital discharge.
- To quantify the incidence of anxiety and depression at three and six months after hospital discharge.
- Quantify the incidence of post-traumatic stress syndrome at 3 and 6 months after hospital discharge.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | Single (Investigator) |
| Masking Description: | 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. |
| Primary Purpose: | Prevention |
| 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. |
| Actual Study Start Date : | May 25, 2020 |
| Actual Primary Completion Date : | October 15, 2021 |
| Actual Study Completion Date : | October 22, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Behavioral: Intervention program
Medical visits: There will be three medical visits stipulated as follows:
Components of visits:
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. |
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No Intervention: 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.
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- Impact of intervention program on health-related quality of life (VAS) [ Time Frame: Six months after discharge ]
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) ]
- Impact of intervention program on health-related quality of life (VAS) [ Time Frame: Three months after discharge. ]
Health-related quality of life reported by the patient assessed through the visual analogue scale of the EQoL 5D / 5L questionnaire at three months after discharge.
[European quality of life 5 dimensions/5 levels ; from 0 (the worst imaginable health) to 100 (the best imaginable health)]
- Impact of intervention program on health-related quality of life (Index) [ Time Frame: Three months after discharge ]
Health-related quality of life reported by the patient assessed through health index of the EQoL 5D/5L questionnaire at three months after discharge.
[European quality of life 5 dimensions/5 levels ; the questionnaire assesses quality of life in study participants according to 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each scored according to a scale of 1 (no problems) to 5 (indicating extreme problems) and generating a 5-digit code corresponding to quality of life]
- Impact of intervention program on health-related quality of life (Index) [ Time Frame: Six months after discharge ]
Health-related quality of life reported by the patient assessed through health index of the EQoL 5D/5L questionnaire at six months after discharge.
[European quality of life 5 dimensions/5 levels ; the questionnaire assesses quality of life in study participants according to 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each scored according to a scale of 1 (no problems) to 5 (indicating extreme problems) and generating a 5-digit code corresponding to quality of life]
- Impact of intervention program on chronic pain (intensity) [ Time Frame: Three and six months after discharge. ]
Chronic pain intensity defined by BPI questionnaire (short version), at three and six months after discharge.
[Brief pain inventory; A multidimensional questionnaire that evaluates pain intensity in the last 24 hours (worst, lowest, average) and current (right now). The questions are rated on a scale of 0 to 10, with 10 being the worst possible value. Subsequently, the average intensity score (BPI intensity score) is calculated.]
- Impact of intervention program on chronic pain (limitation of daily activities) [ Time Frame: Three and six months after discharge. ]
Limitation of daily activities due to chronic pain, defined by BPI (short version), at three and six months after discharge.
[Brief pain inventory; Multidimensional questionnaire that assesses the impact of pain on daily activities (general activity, encouragement, work, relationships with other people, sleep, enjoying life and the ability to walk). The questions are rated on a scale of 0 to 10, with 10 being the worst possible value. Subsequently, the mean score of the responses related to pain interference in activities (BPI interference score) is calculated.]
- Impact of intervention program on chronic pain (Pain catastrophization) [ Time Frame: Three and six months after discharge. ]
Pain catastrophization assessed by Pain Catastrophizing Scale at three and six months after hospital discharge.
[Pain Catastrophizing Scale; Consisting of 13 questions that explore the frequency of thoughts and feelings that the interviewees have in the presence of current or anticipated pain, which are grouped into three scoring subscales (magnification, rumination and defenselessness). Each question is rated on a 5-point scale (0: not at all; 4: all the time). Being the maximum total score of 52 points.]
- Impact of intervention program on anxiety or depression incidence [ Time Frame: Three and six months after discharge. ]
Clinically significant anxiety or depression symptoms prevalence at three and six months, assessed by the HAD test.
[hospital anxiety and depression test; 14 questions, with two subscales, one for anxiety and the other for depression, with seven items each, the maximum score is 21 for each subscale. The cut-off points from zero to seven imply the absence of clinically relevant anxiety and depression, from eight to ten symptoms that require consideration and from 11 to 21 reports the presence of relevant symptoms, with a very probable diagnosis of anxiety or depression.]
- Impact of intervention on probable post-traumatic stress syndrome incidence [ Time Frame: Three and six months after discharge. ]
Probable post-traumatic stress syndrome prevalence at three and six months after discharge assessed by the DSM ( Diagnostic and Statistical Manual of Mental Disorders) V PTSD Checklist questionnaire (PCL-5)
[PTSD Checklist questionnaire; It contains 20 questions that correspond to the DSM V PTSD (Post Traumatic Stress Disorder) criteria. Participants rated their symptoms on a scale of 0 (not at all), 1 (slightly), 2 (moderately), 3 (quite) to 4 (extremely), with a score ranging from 0 to 80. A total of the severity of the symptoms can be made, adding the score of each question (interval 0-80). The severity of each symptom can be evaluated, adding the score of the questions. The cut-off point to use for a provisional diagnosis of PTSD is 31 points.]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394169
| Spain | |
| Tomás Cuñat | |
| Barcelona, Spain, 08036 | |
| Principal Investigator: | Antonio José Ojeda Niño, MD | Pain unit physician |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | TOMAS MIGUEL CUÑAT LOPEZ, Collaborator Investigator, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT04394169 |
| Other Study ID Numbers: |
HCB/2020/0549 |
| First Posted: | May 19, 2020 Key Record Dates |
| Last Update Posted: | December 14, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Covid-19 SARS-COV2 Critical Care Post ICU Syndrome Chronic Pain |
Post-traumatic Stress Disorder Quality of Life Depressive Disorders Anxiety disorders |
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COVID-19 Syndrome Chronic Pain Disease Pathologic Processes Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia |
Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Pain Neurologic Manifestations |