Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601673
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Postoperative Cognitive Training to Prevent Delirium
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Cognitive Training for the Prevention of Delirium in Older Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELtrain
Brief Summary:
The aim of this clinical trial is to test whether daily postoperative cognitive training can prevent delirium in older patients after major surgery
The main questions to be answered is
Can daily cognitive training reduce the rate of postoperative delirium in older patients after surgery
Participants will be visited daily for the first 5 days after surgery and asked to take part in a tablet-based cognitive training programme for 2 hours a day in 2 sessions
The researchers will compare patients who receive the training with a control group of patients who listen to audio books for the same amount of time and a control group who receive standard care no intervention
The main questions to be answered is
Can daily cognitive training reduce the rate of postoperative delirium in older patients after surgery
Participants will be visited daily for the first 5 days after surgery and asked to take part in a tablet-based cognitive training programme for 2 hours a day in 2 sessions
The researchers will compare patients who receive the training with a control group of patients who listen to audio books for the same amount of time and a control group who receive standard care no intervention
Detailed Description:
The most common postoperative complication in aged patients is postoperative delirium POD which often progresses to permanent postoperative neurocognitive disorder pNCD POD and pNCD are associated with significantly increased postoperative morbidity and mortality Prevention of POD is therefore a primary therapeutic goal in the care of elderly patients The aim of this project is to investigate the effect of cognitive stimulation on the occurrence of POD in older patients at risk after surgery
Patients undergoing surgery who are at least 70 years old and have an increased risk of postoperative delirium will be included The increased risk will be assessed in a preoperative assessment as part of the anaesthetic premedication consultation It is defined as the presence of frailty Clinical Frailty Scale CFS and Longitudinal Urban Cohort Study Age Function Index LUCAS-FI cognitive impairment Montreal Cognition Assessment Test MoCA or increased morbidity Hall Risk Analysis Index The intervention takes the form of computer-based cognitive training in the areas of attention processing speed memory emotional intelligence reasoning and orientation Positive effects of this training have already been shown in the treatment of mild cognitive impairment MCI dementia and tumour-related cognitive impairment
The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day It is hypothesised that postoperative cognitive training can reduce the incidence of delirium in the first five days after surgery Secondary endpoints are the reduction of neurocognitive dysfunction at one week six weeks and six months after surgery maintenance of function and quality of life at six months
In order to adjust for the stimulating effects of interacting with study staff during the study visits a control group listening to an audio book also brought and set up by study staff is included in the trial
Patients undergoing surgery who are at least 70 years old and have an increased risk of postoperative delirium will be included The increased risk will be assessed in a preoperative assessment as part of the anaesthetic premedication consultation It is defined as the presence of frailty Clinical Frailty Scale CFS and Longitudinal Urban Cohort Study Age Function Index LUCAS-FI cognitive impairment Montreal Cognition Assessment Test MoCA or increased morbidity Hall Risk Analysis Index The intervention takes the form of computer-based cognitive training in the areas of attention processing speed memory emotional intelligence reasoning and orientation Positive effects of this training have already been shown in the treatment of mild cognitive impairment MCI dementia and tumour-related cognitive impairment
The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day It is hypothesised that postoperative cognitive training can reduce the incidence of delirium in the first five days after surgery Secondary endpoints are the reduction of neurocognitive dysfunction at one week six weeks and six months after surgery maintenance of function and quality of life at six months
In order to adjust for the stimulating effects of interacting with study staff during the study visits a control group listening to an audio book also brought and set up by study staff is included in the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None