Clinical trial NCT03620968: Implementation of a Cognitive Training Program to Reduce the Risk of Postoperative Cognitive Dysfunction
Official title: "Implementation of a Cognitive Training Program in the Elderly to Reduce the Risk of Postoperative Cognitive Dysfunction in Elective Non-cardiac Surgery "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Keywords: Postoperative cognitive dysfunction
Cognitive training
Anaesthesia in Non-cardiac surgery
Elderly adult
Perioperative management.
Lead sponsor: Centro Medico Teknon
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2018-08-08
Enrollment: 225
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* \>55y \<70y
* Patients ASA I, II, II
* Medium or high surgical complexity

Exclusion Criteria:

* \<55y
* previous surgery less than 6 month ago
* psychiatric disease
* Neurological disease
* Brain tumors
* expected survival less than 3 month
* emergencies

Primary outcomes:
measure: Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction
timeFrame: 3 months
Secondary outcomes:
measure: Impact of a training program on the memory alterations
timeFrame: 3month
measure: Impact of a training program on the alteration of the daily memory
timeFrame: 3 month
measure: Impact of a training program on the alterations of anxiety and depression
timeFrame: 3 month
measure: Measure the development of PCD in the different patient groups in relation of age
timeFrame: 3 month
measure: Measure the development of PCD in relation of sex in the different patient groups
timeFrame: 3 month
measure: Measure the development of PCD in relation of duration of surgery in the different patient groups
timeFrame: 3 month
measure: Measure the development of PCD in relation of anesthesia technique in the diferent patient group
timeFrame: 3 month
measure: Measure the development of PCD in relation of type of post operative complications, in the different patient gruops
timeFrame: 3 month
measure: Adherence to the cognitive training program
timeFrame: 3 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Medico Teknon, Servei d'anestesiologia
Study officials:
affiliation: Centro Medico Teknon
name: Josep Rodiera Olivé, MD.Ph.
role: STUDY_DIRECTOR
References:
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