Evaluation to Assess Cognitive Training for the Prevention of Post-operative Cognitive Decline

Charité University Medicine Berlin

Status: Terminated

Conditions: Cognitive Dysfunction

Treatments: Behavioral: Cognitive training program RehaCom®

Study type: Interventional

Funder types: Other

Identifiers

NCT02747784

REACT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

Study group experimental

Experimental group

Description:

24 female patients aged 18 years or older undergoing urogynecological or breast cancer surgery; the patients are recommended to perform the RehaCom® training modules 'Topological Memory (MEMO)' and 'Divided Attention 2 (GEA2)' daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3.

Treatment:

Behavioral: Cognitive training program RehaCom®

Study group active comparator

Active Comparator group

Description:

24 female patients aged 18 years or older undergoing urogynecological or breast cancer surgery; the patients are recommended to perform the RehaCom® training modules 'Topological Memory (MEMO)' and 'Working memory (WOME)' daily during inpatient hospital stay, and at least three times a week for 30 to 60 minutes until month 3.

Treatment:

Behavioral: Cognitive training program RehaCom®

Control group

No Intervention group

Description:

48 female control subjects aged 18 years or older (24 without surgery, 24 with urogynecological or breast cancer surgery) with a similar health status and age as the study group patients (similar distribution in the American Society of Anaesthesiologists physical status classification and relevant co-morbidities, e.g. diabetes, coronary artery disease, hypertension and hyperlipidemia). The patients are analyzed to correct for learning effects of the cognitive assessment testings in the study groups.