Clinical trial NCT02747784: Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline
Official title: Randomized Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline (REACT) - a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive Dysfunction
Keywords: cognitive dysfunction
cognitive training
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Study groups

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.
* Severe visual impairment that affects the neuropsychological testing.
* Participation in other prospective clinical interventional trials
* Daltonism
* Contra-indications against MRI assessment (claustrophobia, metallic implants, cardiac pacemaker, tatoos)
* Motor impairment that affects the use of a computer
* Regular use of psychotropic drugs (including sleep-inducing drugs and benzodiazepines) and substances which affect cognitive performance Control group

Inclusion Criteria:

24 female surgical control subjects from the POCD Register (EA1/104/169) and 24 female non-surgical control subjects

Primary outcomes:
measure: Incidence of postoperative cognitive dysfunction (POCD)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Divided attention
timeFrame: Up to 3 months
measure: Incidence of postoperative delirium
timeFrame: Up to 7 days
measure: Intraoperative depth of sedation
timeFrame: At time of surgery
measure: Depth of sedation on the Intensive Care Unit
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
measure: Intraoperative cerebral oximetry
timeFrame: At time of surgery
measure: Quality of sleep
timeFrame: Up to 3 months
measure: Anxiety
timeFrame: Up to hospital discharge, an expected average of 7 days
measure: Intensive care unit length of stay
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
measure: Hospital length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Evaluation of the cognitive training program RehaCom® by patient
timeFrame: Up to 3 months
measure: Performance of cognitive training units of the program RehaCom®
timeFrame: Up to 3 months
measure: Duration of the cognitive training of the program RehaCom®
timeFrame: Up to 3 months
measure: Frequency of the cognitive training of the program RehaCom®
timeFrame: Up to 3 months
measure: MRI assessment
timeFrame: Up to 3 months
measure: MRI assessment
timeFrame: Up to 3 months
measure: MRI assessment
timeFrame: Up to 3 months
measure: Barthel Activities of Daily Living (ADL) Index
timeFrame: Up to 3 months
measure: Instrumented Activities of Daily Living (IADL)
timeFrame: Up to 3 months
measure: Frailty
timeFrame: Up to 3 months
measure: Generalized anxiety
timeFrame: Up to 3 months
measure: Depression
timeFrame: Up to 3 months
measure: Quality of life
timeFrame: Up to 3 months
measure: Routine laboratory
timeFrame: Up to hospital discharge, an expected average of 7 days
measure: Organ dysfunctions
timeFrame: Up to hospital discharge, an expected average of 7 days
measure: Mortality
timeFrame: Up to three months
measure: Postoperative pain
timeFrame: Up to 3 months
measure: Mild cognitive impairment
timeFrame: Up to 3 months
measure: Timed up and go test
timeFrame: Up to 3 months
measure: Continence
timeFrame: Up to 3 months
measure: Self report on cognitive deficits
timeFrame: Up to 3 months
measure: Metamemory
timeFrame: Up to 3 months
measure: Fatigue
timeFrame: Up to 3 months
measure: Assessment on cognitive deficits by Proxy (IQCODE)
timeFrame: Up to 3 months
measure: BIA (Bio-Impedanz-Analysis)
timeFrame: Up to 3 months
measure: MNA Mini nutritional assessment-MNA short form)
timeFrame: Up to 3 months
measure: Risk factors of dementia
timeFrame: Up to 3 months
measure: Pro- und anti-inflammatory cytokines
timeFrame: Up to 3 months
measure: micro-RNA
timeFrame: Up to 3 months
Other outcomes:
measure: Medication history
timeFrame: From date of inclusion until the date of the beginning of surgery, assessed up to 1 week
measure: Diabetic "yes"/"no"
timeFrame: From date of inclusion until the date of the beginning of surgery, assessed up to 1 week day
measure: Mehrfachwahl-Wortschatztest Form A
timeFrame: From date of inclusion until the date of the beginning of surgery, assessed up to 1 week
measure: Falls within last year
timeFrame: From date of inclusion until the date of the beginning of surgery, assessed up to 1 week day
measure: Charlson Comorbidity index
timeFrame: From date of inclusion until the date of the beginning of surgery, assessed up to 1 week
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.