Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469515
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-11
Brief Title:
Older Peoples Neurocognitive Recovery After Cardiac Surgery
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Enhanced Continuity of Postoperative Care for Older People in Their Neurocognitive Recovery After Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECPON
Brief Summary:
Society is aging and advantages in anesthesia and surgery allow more complex interventions in older persons Old age is a significant risk factor for the development of postoperative neurocognitive decline characterized by a gradual decrease in performance in several cognitive domains such as memory attention information processing and executive functions leading to problems with performing daily activities and maintaining independence and postoperative complications The purpose of this study is to measure older persons postoperative neurocognitive function to detect neurocognitive decline and to identify risk factors and difficulties in daily living as well as explore close relatives experiences of it We will include 220 participants 65 years of age undergoing planned cardiac surgery Cognitive symptoms and signs and neurocognitive function will be assessed up to 6 months after surgery Riskaffected factors such as delirium functional status recovery depression and healthcare-related quality of life as well as close relatives experiences and burden will be measured The results will have immediate relevance for a substantial number of older persons undergoing surgery and their close relatives by enhancing knowledge about postoperative cognitive decline and recovery and subsequently identifying what support needs to be implemented
Detailed Description:
The overarching purpose of the study is to investigate cognitive function symptoms and complaints after cardiac surgery among individuals aged 65 and older as well as to describe the experiences and perspectives of close relatives regarding the same phenomena The study is expected to answer the following scientific research questions
1 What is the incidence of postoperative cognitive decline and the occurrence of cognitive symptoms and complaints in older individuals up to 6 months after cardiac surgery
2 Is there a correlation between preoperative cognitive status and postoperative cognitive decline and if so which cognitive function executive function attention memory is most affected
3 Is there any correlation between postoperative delirium and postoperative cognitive decline and if so which cognitive function is most affected
4 Which factors such as age operation time perceived self-efficacy frailty and depression affect the risk of suffering from postoperative cognitive decline
5 Is postoperative cognitive decline associated with increased symptom burden impaired functional level fatigue frailty deteriorated quality of life and an increased number of unplanned contacts with healthcare services
6 How do older individuals experiencing cognitive symptoms and complaints perceive their postoperative recovery and return to daily life
7 How do close relatives perceive the patients postoperative cognitive function recovery and return to everyday life and how does this affect the relatives own life
The study is a longitudinal observational study with a mixed-method approach planned to be conducted at two thoracic surgical units in Sweden In total 220 patients and one of their relatives are planned to be included and followed up for 6 months after undergoing cardiac surgery The study will be reported following the STrengthening the Reporting of OBservational studies in Epidemiology STROBE guidelines
In connection with the decision on surgery it is assessed whether the patient is suitable for inclusion Potential study participants will receive written and verbal information about the study and will then be asked to participate After the participant has given informed written consent baseline data will be collected This can be done digitally through home visits or at the hospital Included patients will be asked if they have any relatives who can be approached for participation Potential study participants relatives will then be informed about the study and subsequently asked for participation Baseline data from relatives is collected before the time of surgery
Enrolled participants patients will undergo neurocognitive testing before and at 1 3 and 6 months after surgery Mindmore-P is a digitized test battery designed to measure cognitive function The battery consists of four tests that assess various cognitive functions including verbal episodic memory executive function attention and processing speed Mindmore-P is tailored for independent administration via a computer The tests are conducted through a digital platform CE-certified that also contains normative data All other questionnaires can be answered either electronically or in paper format During their hospital stay included participants will be assessed for postoperative delirium twice daily
Descriptive data are presented with mean median frequencyproportion and appropriate measures of dispersion Postoperative cognitive dysfunction is defined as the patient deviating one standard deviation from the baseline measurement on at least two of the cognitive tests included in the cognitive test battery Individual data are adjusted against a norm database to control for variation and learning effects Comparisons between groups will be made using parametric and non-parametric tests based on data level and normal distribution Associations and relationships will be examined with logical multivariate regression models Qualitative data will be analyzed with content analysis Mixed-method analysis may be appropriate to triangulate and compare qualitative and quantitative data to best answer certain scientific questions
1 What is the incidence of postoperative cognitive decline and the occurrence of cognitive symptoms and complaints in older individuals up to 6 months after cardiac surgery
2 Is there a correlation between preoperative cognitive status and postoperative cognitive decline and if so which cognitive function executive function attention memory is most affected
3 Is there any correlation between postoperative delirium and postoperative cognitive decline and if so which cognitive function is most affected
4 Which factors such as age operation time perceived self-efficacy frailty and depression affect the risk of suffering from postoperative cognitive decline
5 Is postoperative cognitive decline associated with increased symptom burden impaired functional level fatigue frailty deteriorated quality of life and an increased number of unplanned contacts with healthcare services
6 How do older individuals experiencing cognitive symptoms and complaints perceive their postoperative recovery and return to daily life
7 How do close relatives perceive the patients postoperative cognitive function recovery and return to everyday life and how does this affect the relatives own life
The study is a longitudinal observational study with a mixed-method approach planned to be conducted at two thoracic surgical units in Sweden In total 220 patients and one of their relatives are planned to be included and followed up for 6 months after undergoing cardiac surgery The study will be reported following the STrengthening the Reporting of OBservational studies in Epidemiology STROBE guidelines
In connection with the decision on surgery it is assessed whether the patient is suitable for inclusion Potential study participants will receive written and verbal information about the study and will then be asked to participate After the participant has given informed written consent baseline data will be collected This can be done digitally through home visits or at the hospital Included patients will be asked if they have any relatives who can be approached for participation Potential study participants relatives will then be informed about the study and subsequently asked for participation Baseline data from relatives is collected before the time of surgery
Enrolled participants patients will undergo neurocognitive testing before and at 1 3 and 6 months after surgery Mindmore-P is a digitized test battery designed to measure cognitive function The battery consists of four tests that assess various cognitive functions including verbal episodic memory executive function attention and processing speed Mindmore-P is tailored for independent administration via a computer The tests are conducted through a digital platform CE-certified that also contains normative data All other questionnaires can be answered either electronically or in paper format During their hospital stay included participants will be assessed for postoperative delirium twice daily
Descriptive data are presented with mean median frequencyproportion and appropriate measures of dispersion Postoperative cognitive dysfunction is defined as the patient deviating one standard deviation from the baseline measurement on at least two of the cognitive tests included in the cognitive test battery Individual data are adjusted against a norm database to control for variation and learning effects Comparisons between groups will be made using parametric and non-parametric tests based on data level and normal distribution Associations and relationships will be examined with logical multivariate regression models Qualitative data will be analyzed with content analysis Mixed-method analysis may be appropriate to triangulate and compare qualitative and quantitative data to best answer certain scientific questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None