Implementation of a Cognitive Training Program to Reduce the Risk of Postoperative Cognitive Dysfunction
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Background: The postoperative cognitive dysfunction (POCD) is a frequent complication, often
      underestimated and leads to a negative impact on the quality of life for patients and their
      families.

      Objective: Measure the effectiveness of the cognitive training in reducing POCD in patients
      55 and 70 years old undergoing elective non cardiac surgery with a degree II-III
      (medium-high) in "Centro Médico Teknon" Barcelona, during 2017-2018.

      Methodology: Randomized control clinical trial. The anticipate sample size is approximately
      225, 75 in each group. Cognitive training performed at different stages of the perioperative
      period. Measure the cognitive function through a battery of neuropsychological tests during
      the preoperative (10 days pre-surgery) and postoperative (at 3 - 30 and 90 days
      post-surgery). Data analysis: SPSS 22, descriptive and inferential analysis: Chi-square,
      Student's t-test, ANOVA and Pearson correlation (p<0,05).

      Limitations: Loss for non-intervention and loss of follow-up. Applicability: Strategy to
      improve the quality of life patients and reduce socioeconomic costs associated.
    

Detailed description: 
      Postoperative Cognitive Dysfunction (PCD) is a frequent and serious complication associated
      with the surgical / anesthetic act. It is an under-recognized and underestimated entity, as
      it can often go unnoticed even though its effects can be devastating. The cognitive domains
      affected are diverse and can include memory, perception, verbal abilities and executive
      functions.

      It is not the only postoperative cognitive disorder and for this reason it is important not
      to confuse it with delirium and dementia. Cognitive dysfunction still does not have a
      diagnostic code formally defined by ICD-10 (International Classification of Disease) or by
      the DSM-V, although the medical field has begun to use this term for the general description
      of those patients who complain about memory alterations and the thought process in the
      postoperative period. Its detection and evaluation depend on the comparative analysis of the
      cognitive function (analyzed by means of neuropsychological tests) betinestigatorsen the pre
      and postoperative period. It is considered, in most of the cases, a mild or moderate
      cognitive impairment of a transient and reversible nature. Its etiology is unknown, and it is
      related to a complex and multifactorial pathophysiology. The most accepted physiopathological
      hypothesis is the inflammatory alteration of the Central nervous system (neuroinflammation)
      due to surgical trauma, with the consequent deterioration of the cognitive reserve
      contributing to a cognitive deficit. At the present moment there is no effective strategy
      tested to prevent PCD.

      Some of the most relevant studies on this disorder inestigatorsre published in The Lancet in
      1998 (Moller et al.) and Anesthesiology in 2008 (Monk et al.). These studies determined that
      surgery and anesthesia caused PCD in the long term. They also concluded that the PCD appears
      in all ages but that old age exponentially increases the risk of suffering it. In addition, a
      low educational level increases the risk of PCD and people who maintain a PCD after 3 months,
      are more likely to experience dementia and a higher mortality risk in the first year after
      surgery.

      The relevant impact of this disorder is dependent on an increase in mortality, a workforce
      loss due to incapacity and early retirement, and social cost due to sick leave, medical and
      nursing homes for the, now dependent, patient.

      At present, it is important to identify, create and evaluate procedures aimed at helping
      patients at risk from this disorder from anesthesia consultations, as a way to help improve
      the outcomes. In this sense, this project proposes the validation of cognitive training as a
      non-pharmacological intervention to reduce incidence and intensity of Postoperative Cognitive
      Dysfunction.

      This intervention is based on the fact that an increase in the neurological functional
      reserve could serve as a protective factor against cognitive dysfunction, improving
      plasticity and brain reserve and subsequently improving the performance of mental capacities,
      through organized techniques and exercises before surgery. It is proposed as the first
      non-pharmacological intervention in cases of normal aging, mild cognitive impairment and
      slight dementia. In addition, it´s low cost and has no significant negative effects.

      Therefore, inestigators propose a cognitive training APP, developed by Spanish
      Neuropsychologists aimed at improving cognitive functions, that can be accessed from an
      online platform meant for practitioners to oversee patient development.

      Main objective: Measure the effectiveness and impact of the cognitive training program
      "Sincrolab" on Postoperative Cognitive Dysfunction in patients aged 55-70 years, after
      elective, non-cardiac, degree-II-III complexity (mid-high), surgery, in Centro Médico Teknon,
      Barcelona, betinestigatorsen 2019-2020

      Specific objectives:

        1. Measure the incidence of PCD in different study groups at 3 days, 1 month and 3 months
           of the surgical procedure.

        2. Compare the evolution of PCD in the intervention group and the control group.

        3. Measure the duration and intensity of the PCD in the different study groups.

        4. Identify the development of PCD in relation to: age, sex, the type of surgical
           intervention, duration of surgery, types of anesthesia, postoperative complication.

        5. Measure the adherence to the proposed cognitive training pattern, determining the rate
           of drop-outs.

      Study Hypothesis The implementation of a cognitive training program during the perioperative
      period decreases the incidence, intensity and duration of Postoperative Cognitive
      Dysfunction.

      Design of the study:

      It is an epidemiological study, located in the empirical-analytic paradigm, that intends to
      obtain knowledge objectively identifying, the cause-effect relationships betinestigatorsen
      cognitive training during the perioperative and the development of PCD, by studying memory
      alterations and executive functions. It's a pre-test/post-test experimental study design,
      with random allocation, and the creation of 3 study groups:

        1. Control group: no cognitive training

        2. Experimental Group 1: Cognitive Training program 10 days prior to surgery.

        3. Experimental Group 2: Cognitive Training program 10 days prior to surgery continuing for
           over a inestigatorsek after surgery.

      The evaluation of the cognitive function will be carried out following the same protocol for
      all the three groups and will take place at different times of the perioperative period,
      initially on the preanesthesia visit to set a baseline, and later on the postoperative period
      at 3 days, 1 month and 3 month post-surgery.

      Study population:

      Men and women, ASA I-III, betinestigatorsen 55-70 years of age who are visited in the
      pre-anesthesia clinic, and scheduled for elective, noncardiac surgery, understand the purpose
      of the study, sign informed consent and meet the selection criteria.

      Variables:

      Independent: Cognitive training, through the computer application "Sincrolab". Dependent:
      Development of PCD, measured through the application of a neuropsychological test battery
      that test the cognitive domain of memory and executive functions.

      The implementation of an effective program for screening, prevention and treatment of the
      PCD, can have a direct impact on patient safety, improve outcomes of surgical interventions
      and help in maintaining quality of life and active role in society of our older patients.

      With the aging of the population, PCD is a problem that will become increasingly important to
      measure, and inestigators can imagine a multidisciplinary approach to be necessary since a
      patient disabled by PCD is a health problem with important economic and social connotations.
      Therefore, the preservation of the brain's functional and cognitive capacities deserves all
      of our attention and interest.
    

Intervention name(s): cognitive training
Intervention type(s): Other
Intervention description(s): 15 minutes day of brain training by an APP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Postoperative cognitive dysfunction; Cognitive training; Anaesthesia in Non-cardiac surgery; Elderly adult; Perioperative management.