Cognitive Rehabilitation for People With Cognitive Covid19

Study Overview
=================
Brief Summary
-----------------
Cognitive impairment is increasingly recognised as a major component of long Covid, and is estimated to be present in 25-75% of affected individuals. This impairment impacts quality of life and the loss of functional ability has major consequences for affected people, their families and the wider economy given people's difficulty in returning to work. This study will focus on helping people recover from cognitive Covid. This will involve use of rehabilitation strategies aimed at improving function in those cognitive functions identified in Stage 1 as being most affected, and assessing the benefit of rehabilitation on quality of life and people's ability to return to everyday function. These strategies will be co-produced in collaboration with a group of people living with cognitive Covid. At the end of Stage 2 we will produce a freely available Covid-19 Cognitive Recovery Guide for affected people, their close contacts and clinicians. In conclusion, cognitive impairment is frequently observed in long Covid but at present little is understood about its nature, or how it can be treated. The sheer scale of the CV19 pandemic makes this a top priority unmet need for healthcare worldwide. The aim of this study is to meet this need and to deliver a treatment plan for affected people which will help them return to normal life and working ability.

Official Title
-----------------
Cognitive Impairment in Long Covid: PhEnotyping and RehabilitatiOn (CICERO)

Conditions
-----------------
Long Covid19

Intervention / Treatment
-----------------
* Behavioral: Cognitive rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 30 and 60 years Evidence of prior CV19 infection: either positive CV19 PCR or positive CV19 antibody test or acute symptoms consistent with the recognised core features of acute CV19 infection and post-acute symptoms consistent with the recognised core features of long Covid Cognitive impairment persisting more than three months after the acute CV19 infection, defined in terms of subjective reports of cognitive decline post-infection Exclusion Criteria: Cognitive impairment prior to CV19 infection Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition High alcohol intake Recreational drug use Loss of mental capacity such that the affected individual is unable to give informed consent Participants will not be eligible for Workstream 2 if they do not exhibit significant impairment on baseline cognitive assessments, as they will not gain from cognitive rehabilitation. Participants with pacemakers or other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have had certain types of surgery will be excluded from the MRI substudy. Although MRI is not known to affect the unborn child, we will also exclude subjects who may be pregnant just to be on the safe side.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>cognitive rehabilitation programme. 1h session per week x 10 weeks | Behavioral: Cognitive rehabilitation<br>* Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.<br>|
| No Intervention: Control<br>The control group receives treatment as usual, this is, participants will carry on with the care they were receiving prior to entry in the study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Goal-attainment | performance on goals selected by participants | measured at baseline, 3 and 6 months post-randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | set of tests to measure objective improvements in cognitive function | measured at baseline, 3 and 6 months post-randomisation | 
| Change in quality of life (EQ-5D-5L) | Measure of quality of life | measured at baseline, 3 and 6 months post-randomisation | 
| Change in Life Space Questionnaire | Measures the extent of mobility | measured at baseline, 3 and 6 months post-randomisation | 
| Social Functioning (SF-DEM) | patient reported outcome measure to assess social functioning | measured at baseline, 3 and 6 months post-randomisation | 
| Change in Instrumental Activities of Daily Living (IADL) Scale | assessment of independent living skills | measured at baseline, 3 and 6 months post-randomisation | 
| Generalised Anxiety Disorder Assessment (GAD-7) | measures levels of anxiety | measured at baseline, 3 and 6 months post-randomisation | 
| Change in Patient Health Questionnaire (PHQ-8) | measures depressive disorders | measured at baseline, 3 and 6 months post-randomisation | 
| Change in Chalder Fatigue Scale | measures the severity of tiredness in fatiguing illnesses | measured at baseline, 3 and 6 months post-randomisation | 
| Change in Pittsburgh Sleep Quality (PSQI) | slef reported questionnaire that assesses sleep quality | measured at baseline, 3 and 6 months post-randomisation | 
| Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM). | measures presence and severity of post-exertional malaise | measured at baseline, 3 and 6 months post-randomisation | 
| Change in Client Service Receipt Inventory (CSRI) | tool used to collect information on the whole range of services and supports study participants may use | measured at baseline, 3 and 6 months post-randomisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive rehabilitation, brain fog, Covid19