Postoperative DeliriumDELtrainNCT06601673
Postoperative Cognitive Training to Prevent Delirium
A study testing Cognitive training and Listen to audio book in people with Postoperative Delirium, run by Universitätsklinikum Hamburg-Eppendorf.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Cognitive training and Listen to audio book
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 70 years or older,
- planned surgery (abdominal surgery: general surgery, urology or gynaecology; spinal surgery, vascular medicine, cardiothoracic surgery, major trauma surgery),
- increased perioperative risk (frailty, cognitive impairment, multimorbidity).
Who cannot join
- Unable to give consent,
- severe cognitive disorder or mental retardation (if training cannot be carried out)
- Insufficient knowledge of German
About this study
Official title: Postoperative Cognitive Training for the Prevention of Delirium in Older Patients
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).
Read the 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.
- Conditions
- Postoperative Delirium
- Being tested
- Cognitive training, Listen to audio book
- Keywords
- older patients, frailty, neurocognitive disorder, cognitive stimulation, anaesthesia
- Medical subject headings
- Emergence Delirium, Frailty, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Also called cognitive stimulation
The intervention consists of computer-based cognitive training in the areas of attention, processing speed, memory, emotional intelligence, reasoning and orientation. The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day.
Listen to audio bookBehavioural
Here, an audio book is listened to for 2h daily for the first five postoperative days (or until discharge from hospital if earlier). The audio book is brought and set up by study staff.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Tablet-based bed-side cognitive training for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier). Receives: Behavioral: Cognitive training |
| Audio book | Sham comparator | Listening to an audio book for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier). Receives: Behavioral: Listen to audio book |
| Standard care | No intervention | Standard care without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium within the first five days after surgery
Delirium screened twice daily using the 3D-Confusion Assessment Method (3D-CAM) for the first five days after surgery (0-4 hallmarks; hallmark 1+2 and 3+4 = delirium)
Measured: delirium screening twice daily from postoperative day 1-5
Secondary outcomes (11)
postoperative neurocognitive disorder
delayed neurocognitive recovery (compared to baseline), measured by telephone-Montreal Cognitive Assessment (MOCA) (0-15 points; 10 points or less = cognitive impairment)
Measured: postoperative day 7 (1 week after surgery)
postoperative neurocognitive disorder
compared to baseline, measured by telephone-MOCA (0-15 points; 10 points or less = cognitive impairment)
Measured: 6 weeks after surgery
postoperative neurocognitive disorder
compared to baseline, measured by telephone-MOCA (0-15 points; 10 points or less = cognitive impairment)
Measured: 6 months after surgery
Functional state (patient-reported)
compared to baseline, assessed by World Health Organization Disability Assessment (WHODAS) 2.0 questionnaire (36-item, likert scale)
Measured: 6 weeks after surgery
Functional state (measured)
compared to baseline, assessed by functional independence measure (FIM) (18 items with 0-7 points each, less points = less functionality)
Measured: 6 weeks after surgery
Functional state (patient-reported)
compared to baseline, assessed by WHODAS 2.0 questionnaire (36-item, likert scale)
Measured: 6 months after surgery
Functional state (measured)
compared to baseline, assessed by functional independence measure (FIM) (18 items with 0-7 points each, less points = less functionality)
Measured: 6 months after surgery
Quality of Life (by questionnaire)
compared to baseline, assessed by World Health Organization Quality of Life -older adults module (WHOQOL-OLD)-questionnaire (24 item, likert scale)
Measured: 6 weeks after surgery
Quality of Life (by questionnaire)
compared to baseline, assessed by World Health Organization Quality of Life -older adults module (WHOQOL-OLD)-questionnaire (24 item, likert scale)
Measured: 6 months after surgery
Quality of Life (by visual analogue scale)
compared to baseline, assessed by EQ-5D-5L- questionnaire (0-100 points, 100 points = best quality of life)
Measured: 6 weeks after surgery
Quality of Life (by visual analogue scale)
compared to baseline, assessed by EQ-5D-5L- questionnaire (0-100 points, 100 points = best quality of life)
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startMay 2014
- Primary completionMar 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized-controlled trial
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601673
- Sponsor's protocol ID
- S6-2024
- Other IDs
- 2024-101267-BO-ff
- Acronym
- DELtrain
- Status last verified
- Feb 2025
- First submitted
- 30 Jul 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Training for the Prevention of Delirium in Older Patients
- ClinicalTrials.gov ID
- NCT06601673
- Acronym / sponsor ID
- DELtrain / S6-2024
- Conditions
- Postoperative Delirium
- Keywords
- older patients, frailty, neurocognitive disorder, cognitive stimulation, anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective, randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive trainingTablet-based bed-side cognitive training for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier). |
| Audio book | Sham comparator | Behavioral: Listen to audio bookListening to an audio book for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier). |
| Standard care | No intervention | –Standard care without any intervention. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients aged 70 years or older,
- planned surgery (abdominal surgery: general surgery, urology or gynaecology; spinal surgery, vascular medicine, cardiothoracic surgery, major trauma surgery),
- increased perioperative risk (frailty, cognitive impairment, multimorbidity).
Key exclusion criteria (3 listed)
- Unable to give consent,
- severe cognitive disorder or mental retardation (if training cannot be carried out)
- Insufficient knowledge of German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingAlso: cognitive stimulationThe intervention consists of computer-based cognitive training in the areas of attention, processing speed, memory, emotional intelligence, reasoning and orientation. The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day. | Behavioural | Intervention |
| Listen to audio bookHere, an audio book is listened to for 2h daily for the first five postoperative days (or until discharge from hospital if earlier). The audio book is brought and set up by study staff. | Behavioural | Audio book |
Primary outcome
Postoperative delirium within the first five days after surgery
Time frame: delirium screening twice daily from postoperative day 1-5
Delirium screened twice daily using the 3D-Confusion Assessment Method (3D-CAM) for the first five days after surgery (0-4 hallmarks; hallmark 1+2 and 3+4 = delirium)
11 secondary outcomes
postoperative neurocognitive disorder
Time frame: postoperative day 7 (1 week after surgery)
postoperative neurocognitive disorder
Time frame: 6 weeks after surgery
postoperative neurocognitive disorder
Time frame: 6 months after surgery
Functional state (patient-reported)
Time frame: 6 weeks after surgery
Functional state (measured)
Time frame: 6 weeks after surgery
Functional state (patient-reported)
Time frame: 6 months after surgery
Functional state (measured)
Time frame: 6 months after surgery
Quality of Life (by questionnaire)
Time frame: 6 weeks after surgery
Quality of Life (by questionnaire)
Time frame: 6 months after surgery
Quality of Life (by visual analogue scale)
Time frame: 6 weeks after surgery
Quality of Life (by visual analogue scale)
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Listen to audio book in people with Postoperative Delirium, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium within the first five days after surgery (time frame: delirium screening twice daily from postoperative day 1-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.