Implementation of a Cognitive Training Program to Reduce the Risk of Postoperative Cognitive Dysfunction
Primary Purpose
Postoperative Cognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cognitive training
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Cognitive Dysfunction focused on measuring Postoperative cognitive dysfunction, Cognitive training, Anaesthesia in Non-cardiac surgery, Elderly adult, Perioperative management.
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
Sites / Locations
- Centro Medico Teknon, Servei d'anestesiologia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Control, no intervention
Intervention before surgery (cognitive training)
Intervention Before and after surgery (cognitive training)
Outcomes
Primary Outcome Measures
Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction
Impact of a training program on the cognitive dysfunction measured with: Mini-cog test for. Scale: 0-5, normal values > 3; measurements at 3 days, 1 month and 3 month after surgery
Secondary Outcome Measures
Impact of a training program on the memory alterations
Impact of a training program on the memory alterations measured with T@M test. Scale: 0-50. normal values > 35 and < 5 minutes execution test time.; measurements at 3 days, 1 month and 3 month after surgery
Impact of a training program on the alteration of the daily memory
Impact of a training program on the alteration of the daily memory measured with test: MFE Test for evaluation of the daily memory. Scale 0-84. normal values: Variations < 20%; measurements at 3 days, 1 month and 3 month after surgery
Impact of a training program on the alterations of anxiety and depression
Impact of a training program on the alterations of anxiety and depression measured with Goldberg Test. Anxiety scale: 0-9, normal values < 5, Depression scale: 0-9, normal values <3; measurements at 3 days, 1 month and 3 month after surgery
Measure the development of PCD in the different patient groups in relation of age
Measure the development of the PCD in the different patient groups in relation of the age of the patient. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression.
Measure the development of PCD in relation of sex in the different patient groups
Measure the development of the PCD in the different patient groups in relation of sex of the patient. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Measure the development of PCD in relation of duration of surgery in the different patient groups
Measure the development of the PCD in the different patient groups in relation of the duration of the surgery. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Measure the development of PCD in relation of anesthesia technique in the diferent patient group
Measure the development of the PCD in the different patient groups in relation of the type of anesthesia. General intravenous anesthesia, general inhalatory anesthesia, regional anesthesia. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Measure the development of PCD in relation of type of post operative complications, in the different patient gruops
Measure the development of the PCD in the different patient groups in relation of the post-operative complications. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Adherence to the cognitive training program
Assessment of the adherence to the proposed cognitive training, determining the rate of drop-outs in the PCD
Full Information
NCT ID
NCT03620968
First Posted
December 26, 2017
Last Updated
March 8, 2022
Sponsor
Centro Medico Teknon
Collaborators
University of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03620968
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Medico Teknon
Collaborators
University of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Measure the incidence of PCD in different study groups at 3 days, 1 month and 3 months of the surgical procedure.
Compare the evolution of PCD in the intervention group and the control group.
Measure the duration and intensity of the PCD in the different study groups.
Identify the development of PCD in relation to: age, sex, the type of surgical intervention, duration of surgery, types of anesthesia, postoperative complication.
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:
Control group: no cognitive training
Experimental Group 1: Cognitive Training program 10 days prior to surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Postoperative cognitive dysfunction, Cognitive training, Anaesthesia in Non-cardiac surgery, Elderly adult, Perioperative management.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Control, no intervention
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Intervention before surgery (cognitive training)
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Intervention Before and after surgery (cognitive training)
Intervention Type
Other
Intervention Name(s)
cognitive training
Intervention Description
15 minutes day of brain training by an APP
Primary Outcome Measure Information:
Title
Measure the effectiveness of a cognitive training program on the post op cognitive dysfunction
Description
Impact of a training program on the cognitive dysfunction measured with: Mini-cog test for. Scale: 0-5, normal values > 3; measurements at 3 days, 1 month and 3 month after surgery
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Impact of a training program on the memory alterations
Description
Impact of a training program on the memory alterations measured with T@M test. Scale: 0-50. normal values > 35 and < 5 minutes execution test time.; measurements at 3 days, 1 month and 3 month after surgery
Time Frame
3month
Title
Impact of a training program on the alteration of the daily memory
Description
Impact of a training program on the alteration of the daily memory measured with test: MFE Test for evaluation of the daily memory. Scale 0-84. normal values: Variations < 20%; measurements at 3 days, 1 month and 3 month after surgery
Time Frame
3 month
Title
Impact of a training program on the alterations of anxiety and depression
Description
Impact of a training program on the alterations of anxiety and depression measured with Goldberg Test. Anxiety scale: 0-9, normal values < 5, Depression scale: 0-9, normal values <3; measurements at 3 days, 1 month and 3 month after surgery
Time Frame
3 month
Title
Measure the development of PCD in the different patient groups in relation of age
Description
Measure the development of the PCD in the different patient groups in relation of the age of the patient. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression.
Time Frame
3 month
Title
Measure the development of PCD in relation of sex in the different patient groups
Description
Measure the development of the PCD in the different patient groups in relation of sex of the patient. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Time Frame
3 month
Title
Measure the development of PCD in relation of duration of surgery in the different patient groups
Description
Measure the development of the PCD in the different patient groups in relation of the duration of the surgery. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Time Frame
3 month
Title
Measure the development of PCD in relation of anesthesia technique in the diferent patient group
Description
Measure the development of the PCD in the different patient groups in relation of the type of anesthesia. General intravenous anesthesia, general inhalatory anesthesia, regional anesthesia. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Time Frame
3 month
Title
Measure the development of PCD in relation of type of post operative complications, in the different patient gruops
Description
Measure the development of the PCD in the different patient groups in relation of the post-operative complications. Measured in the different study areas: cognitive, memory, daily memory, anxiety and depression
Time Frame
3 month
Title
Adherence to the cognitive training program
Description
Assessment of the adherence to the proposed cognitive training, determining the rate of drop-outs in the PCD
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Rodiera Olivé, MD.Ph.
Organizational Affiliation
Centro Medico Teknon
Official's Role
Study Director
Facility Information:
Facility Name
Centro Medico Teknon, Servei d'anestesiologia
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26620148
Citation
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23890520
Citation
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Results Reference
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PubMed Identifier
25944109
Citation
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Results Reference
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PubMed Identifier
18156878
Citation
Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.
Results Reference
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Citation
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Citation
Shu AH, Wang Q, Chen XB. Effect of different depths of anesthesia on postoperative cognitive function in laparoscopic patients: a randomized clinical trial. Curr Med Res Opin. 2015;31(10):1883-7. doi: 10.1185/03007995.2015.1075968. Epub 2015 Sep 4.
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Citation
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Citation
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Results Reference
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Implementation of a Cognitive Training Program to Reduce the Risk of Postoperative Cognitive Dysfunction
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