Randomized Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline (REACT) - a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognitive Dysfunction
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Incidence of postoperative cognitive dysfunction (POCD)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this open, monocentric randomized, parallel-group, controlled trial is to compare two different computer-based cognitive training programs regarding the efficacy to prevent the 3-months incidence of postoperative cognitive dysfunction in female patients after elective urogynecological or breast cancer surgery.
Detailed Description
The REACT trial has been designed as a feasibility study to investigate the impact of pre-, peri-, and postoperative computerized cognitive trainings on the incidence of postoperative cognitive dysfunction. Two different study groups (training programs) will be compared. Each group consists of two training modules of the validated computer based training program of cognitive functioning called RehaCom®. The experimental group consists of the modules 'Topological Memory (MEMO)' and 'Divided Attention 2 (GEA2)'. The active comparator group consists of the modules 'Topological Memory (MEMO)' and 'Working memory (WOME)'. 48 surgical patients undergoing elective urogynecological or breast cancer surgery will preoperatively be randomly assigned to one of two study groups. Before starting the training, patients will complete a neuropsychological test battery comprising the cognitive tests to measure POCD. The tests will be assessed at preoperative baseline visit and at 3-months follow-up. In order to correct change in cognitive performance for practice effects, a group of 24 female surgical control subjects will also prospectively be tested with the cognitive test battery at baseline and 3-months follow-up. The control subjects will be matched to the 2 study groups regarding health status, surgery and age, but will neither undergo the computerized cognitive training program RehaCom®. Further, 24 female control subjects are included from the POCD-Register (EA1/104/16) and will be matched to the 2 study groups as well. After baseline assessment, the study group patients will be taught to use the training program RehaCom®, and training should start preoperatively as early as possible. The patients are recommended to perform the training daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3. The neuropsychological assessment will be performed at preoperative baseline and at three-months follow-up. Postoperative cognitive dysfunction (POCD) will be classified using the dichotomous approach established by Rasmussen et al in the International Study on postoperative cognitive deficits (ISPOCD) (Rasmussen et al. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89.) This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters). Secondary outcome measures of this trial comprise structural and functional MRI measures, Electroencephalogram simultaneous with fMRI, intraoperative cerebral oximetry and neuromonitoring, delirium, pain, sleep quality, postoperative complications, frailty, psychological distress, quality of life, training performance and evaluation of the training.
Investigators
Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow - Klinikum (CVK)/Campus Charité Mitte (CCM), Charité - University Medicine Berlin
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •Pilot study: Female patients undergoing urogynecological or breast cancer surgery, screened at the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
- •Age 18 years or older
- •Montreal Cognitive Assessment Score (MOCA) \> 25
- •Patient has access to Personal computer or Laptop with system software Windows XP Service Pack 3 (or newer); tablets or smart phones cannot by used.
- •Written informed consent to participate after having been properly instructed
- •Written informed consent that accidental clinically relevant diagnostic findings of MRI assessment are reported to the general practitioner of the patient
- •Sufficient health insurance to cover additional diagnostic assessments in case of an accidental clinically relevant diagnostic finding of MRI assessment
Exclusion Criteria
- •Apparent dementia
- •Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
- •Lacking willingness to be contacted by telephone or mail.
- •Accommodation in an institution due to an official or judicial order
- •Insufficient knowledge of German language
- •Members of the hospital staff
- •Admitted in police custody
- •Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone
- •Illiteracy
- •Severe hearing impairment that affects the neuropsychological testing.
Outcomes
Primary Outcomes
Incidence of postoperative cognitive dysfunction (POCD)
Time Frame: Up to 3 months
Cognitive functioning will be measured with a battery of computerized neuropsychological tests, non-computerized and computer-based tests from the Cambridge Neuropsychological Test Automated Battery \[CANTAB®\]
Secondary Outcomes
- Depth of sedation on the Intensive Care Unit(Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days)
- Quality of sleep(Up to 3 months)
- Divided attention(Up to 3 months)
- Intraoperative depth of sedation(At time of surgery)
- Incidence of postoperative delirium(Up to 7 days)
- Intraoperative cerebral oximetry(At time of surgery)
- Duration of the cognitive training of the program RehaCom®(Up to 3 months)
- Mild cognitive impairment(Up to 3 months)
- Self report on cognitive deficits(Up to 3 months)
- Assessment on cognitive deficits by Proxy (IQCODE)(Up to 3 months)
- Hospital length of stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Evaluation of the cognitive training program RehaCom® by patient(Up to 3 months)
- Instrumented Activities of Daily Living (IADL)(Up to 3 months)
- Frailty(Up to 3 months)
- Quality of life(Up to 3 months)
- Anxiety(Up to hospital discharge, an expected average of 7 days)
- Intensive care unit length of stay(Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days)
- Performance of cognitive training units of the program RehaCom®(Up to 3 months)
- Frequency of the cognitive training of the program RehaCom®(Up to 3 months)
- MRI assessment(Up to 3 months)
- Barthel Activities of Daily Living (ADL) Index(Up to 3 months)
- Generalized anxiety(Up to 3 months)
- Depression(Up to 3 months)
- Organ dysfunctions(Up to hospital discharge, an expected average of 7 days)
- Timed up and go test(Up to 3 months)
- Metamemory(Up to 3 months)
- Risk factors of dementia(Up to 3 months)
- Routine laboratory(Up to hospital discharge, an expected average of 7 days)
- Mortality(Up to three months)
- Pro- und anti-inflammatory cytokines(Up to 3 months)
- Postoperative pain(Up to 3 months)
- Continence(Up to 3 months)
- Fatigue(Up to 3 months)
- BIA (Bio-Impedanz-Analysis)(Up to 3 months)
- micro-RNA(Up to 3 months)
- MNA Mini nutritional assessment-MNA short form)(Up to 3 months)