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

NCT02747784 | Terminated

• 1 other identifier: REACT
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Keywords

cognitive dysfunction; cognitive training

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cognitive dysfunction (POCD)

  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 \[CANTAB®\]

  Up to 3 months

Secondary Outcomes (38)

• Divided attention

  Up to 3 months

• Incidence of postoperative delirium

  Up to 7 days

• Intraoperative depth of sedation

  At time of surgery

• 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

• Intraoperative cerebral oximetry

  At time of surgery

Other Outcomes (5)

• Medication history

  From date of inclusion until the date of the beginning of surgery, assessed up to 1 week

• Diabetic "yes"/"no"

  From date of inclusion until the date of the beginning of surgery, assessed up to 1 week day

• Mehrfachwahl-Wortschatztest Form A

  From date of inclusion until the date of the beginning of surgery, assessed up to 1 week

Study Arms (3)

Study group experimental

EXPERIMENTAL

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.

Behavioral: Cognitive training program RehaCom®

Study group active comparator

ACTIVE COMPARATOR

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.

Behavioral: Cognitive training program RehaCom®

Control group

NO INTERVENTION

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.

Interventions

Cognitive training program RehaCom® BEHAVIORAL

Cognitive training program RehaCom®

Study group active comparator; Study group experimental

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 11207462 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine, Campus Virchow - Klinikum (CVK)/Campus Charité Mitte (CCM), Charité - University Medicine Berlin

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 22, 2016
• Study Start: July 25, 2017
• Primary Completion: September 7, 2018
• Study Completion: September 28, 2018
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)