Cognitive Rehabilitation for People With Cognitive Covid19

NCT05731570 | Active Not Recruiting

• 1 other identifier: CICERO clinical trial
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Long Covid19

Keywords

cognitive rehabilitation; brain fog; Covid19

Outcome Measures

Primary Outcomes (1)

• Change in Goal-attainment

  performance on goals selected by participants

  measured at baseline, 3 and 6 months post-randomisation

Secondary Outcomes (11)

• Change in cognitive function

  measured at baseline, 3 and 6 months post-randomisation

• Change in quality of life (EQ-5D-5L)

  measured at baseline, 3 and 6 months post-randomisation

• Change in Life Space Questionnaire

  measured at baseline, 3 and 6 months post-randomisation

• Social Functioning (SF-DEM)

  measured at baseline, 3 and 6 months post-randomisation

• Change in Instrumental Activities of Daily Living (IADL) Scale

  measured at baseline, 3 and 6 months post-randomisation

Study Arms (2)

Intervention

EXPERIMENTAL

cognitive rehabilitation programme. 1h session per week x 10 weeks

Behavioral: Cognitive rehabilitation

Control

NO INTERVENTION

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.

Interventions

Cognitive rehabilitation BEHAVIORAL

Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.

Intervention

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• Bangor University: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• University of Brighton: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Greater Manchester Mental Health NHS Foundation Trust: collaborator

Study Sites (1)

University College London

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

• Vanova M, Patel AMR, Scott I, Gilpin G, Manning EN, Ash C, Wittenberg P, Lim J, Hoare Z, Evans R, Bray N, Kipps CM, Devine C, Ahmed S, Dunne R, Koniotes A, Warren C, Chan D, Suarez-Gonzalez A. Telehealth-delivered cognitive rehabilitation for people with cognitive impairment as part of the post-COVID syndrome: protocol for a randomised controlled trial as part of the CICERO (Cognitive Impairment in Long COVID: Phenotyping and Rehabilitation) study. Trials. 2024 Oct 22;25(1):704. doi: 10.1186/s13063-024-08554-3.

  PMID: 39434179 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mental Fatigue; COVID-19

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dennis Chan, Dr

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 16, 2023
• Study Start: February 14, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)