Postoperative Cognitive DysfunctionECPONNCT06469515
Older People's Neurocognitive Recovery After Cardiac Surgery
An observational study of Postoperative Cognitive Dysfunction and Postoperative Recovery, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Recovery, Cardiac Surgery
- What is being tested?
- Elective or urgent cardiac surgery
- How many people
- 220 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consists of patients (65 years or older) who have undergone cardiac surgery and their relatives. The study participant is qualified for inclusion if he or she meets all the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Scheduled for elective or urgent open-heart surgery or minimally invasive cardiac surgery
- Resident in the area/region for the current thoracic clinic
- Able to read and understand Swedish
Who cannot join
- Physical, mental, and cognitive difficulties that prevent the individual from completing the cognitive tests
- Undergone surgery within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ulrica Nilsson, Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Tor Damén, MD, PhD
About this study
Official title: Enhanced Continuity of Postoperative Care for Older People in Their Neurocognitive Recovery After Cardiac Surgery
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. Risk/affected factors such as delirium, functional status, recovery, depression, and healthcare-related quality of life, as well as close relative's 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.
Read the 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:
- 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?
- 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?
- Is there any correlation between postoperative delirium and postoperative cognitive decline, and if so, which cognitive function is most affected?
- Which factors (such as age, operation time, perceived self-efficacy, frailty, and depression) affect the risk of suffering from postoperative cognitive decline?
- 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?
- How do older individuals experiencing cognitive symptoms and complaints perceive their postoperative recovery and return to daily life?
- How do close relatives perceive the patient's postoperative cognitive function, recovery, and return to everyday life, and how does this affect the relative's 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.
Descriptive data are presented with mean, median, frequency/proportion, 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.
- Being tested
- Elective or urgent cardiac surgery
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective or urgent cardiac surgeryOther
This is a longitudinal observational study to explore postoperative cognitive recovery among older persons (aged 65 or older) undergoing elective or urgent cardiac surgery via sternotomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive complaints
The Swedish Quality of Recovery cognitive version (SwQoR-Cog) is a self-assessment questionnaire that measures postoperative symptoms. The form consists of 14 statements regarding symptoms and discomforts, of which 11 address cognitive symptoms and 3 are related to pain and nausea. Symptoms and discomforts are rated on an 11-point scale (0=not at all to 10=all the time).
Measured: Before surgery and weekly up to three months after surgery
Changes in postoperative cognitive function, part 1
Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) A 10-word verbal learning test with 3 learning trials, a recall trial after ~7 min.
Measured: Before surgery and 1, 3, and 6 months after surgery
Changes in postoperative cognitive function, part 2
Trail Making Test (TMT- A \& B) consists of 25 circles with letters or numbers on the screen.
Measured: Before surgery and 1, 3, and 6 months after surgery
Changes in postoperative cognitive function, part 3
Stroop Colour-Word Test (SCW). 24 words spelling out the name of a colour which is printed in contrasting ink colours (e.g., the word "green" printed with red ink), and the participant is asked to tell the printed colour of the word rather than the word rather than the actual meaning of the word.
Measured: Before surgery and 1, 3, and 6 months after surgery
Changes in postoperative cognitive function, part 4
Symbol Digits Processing Test (SDPT). The test consists of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom.
Measured: Before surgery and 1, 3, and 6 months after surgery
Secondary outcomes (12)
Postoperative delirium
The Nursing Delirium Scale (Nu-DESC) is an assessment scale where five symptoms are identified and evaluated. A total score of ≥ 2 points indicates the presence of delirium.
Measured: Twice daily up to postoperative day 7
Perceived self-efficacy
The Swedish General Self-Efficacy Scale (S-GSE) is an instrument that measures perceived self-efficacy in problem-solving and goal achievement. The tool consists of 10 statements that are answered on a 4-point scale, ranging from 1 (not at all true) to 4 (exactly true). This scale is designed to assess an individual's belief in their ability to cope with a variety of difficult demands in life.
Measured: Before surgery and 1, 3, and 6 months after surgery
Depressive symtoms
The Patient Health Questionnaire (PHQ-9) is a questionnaire that measures depressive symptoms. The form consists of 9 statements that are answered on a 4-point scale (0=not at all to 3=nearly every day). A total score of ≥ 10 indicates depressive symptoms.
Measured: Before surgery and 1, 3, and 6 months after surgery
Functional activity
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a tool that measures the level of functioning. The instrument consists of 12 questions that address difficulties related to health conditions, which are rated on a 5-point scale (1=no difficulty to 5=extreme difficulty/cannot do). A change of ≥5% compared to the baseline measurement indicates a clinically significant difference in the level of functioning.
Measured: Before surgery and 1, 3, and 6 months after surgery
Frailty
The Clinical Frailty Scale (CFS) is an assessment scale of frailty consisting of nine levels (1=very fit to 9=terminally ill). The assessment is conducted by trained healthcare professionals by having the patient (or a relative) answer questions about their level of capacity two weeks prior.
Measured: Before surgery and at 6 months after surgery
Fatigue
The Fatigue Scale for Motor and Cognitive Functions (FSMC) is a questionnaire that measures extreme forms of fatigue. The form consists of 20 statements concerning extreme fatigue and how it affects the participant's daily life and is answered on a 5-point scale (1= not true at all to 5= completely true). The FSMC measures both cognitive and physical fatigue. A total score of ≥ 43 indicates mild fatigue, ≥ 53 indicates moderate fatigue, and ≥ 63 indicates severe fatigue.
Measured: Before surgery and at 6 months after surgery
Health-related quality of life as assessed by RAND-36
RAND-36 is a questionnaire that measures health-related quality of life. The survey consists of 36 questions that assess 8 different domains of health: physical functioning, role limitations due to physical health, role limitations due to emotional problems, social functioning, emotional well-being, vitality, pain, and general health. Two different composite scores can be calculated for physical and mental health status, where a score of 50 or above indicates poor physical/mental health status.
Measured: Before surgery and at 6 months after surgery
Close relatives' assessment of cognition
The Cognitive Failures Questionnaire for Others (f-CFQ) will be used to measure relatives' assessment of the patient's cognition. The instrument consists of 8 questions that assess the frequency of cognitive problems in daily life related to memory, attention, motor skills, and perception. The questions are answered on a 4-point scale ranging from (0=never to 4=very often).
Measured: Before surgery and 1, 3, and 6 months after surgery
Caregiver burden
The Short Form Zarit Burden Interview (ZBI-12) will be used to measure caregiver burden. ZBI-12 consists of 12 questions that are answered on a 5-point scale (0=never to 4=almost always).
Measured: Before surgery and 1, 3 and 6 months after surgery
Experiences of cognitive recovery
Qualitative semi-structured interviews
Measured: At 6 months after surgery
Close relatives experience
Qualitative semi-structured interviews
Measured: At 6 months after surgery
Unplanned healthcare visits
Study-specific questionnaire where participants will register any unplanned contacts or visits with healthcare services.
Measured: At 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 posted21 Jun 2024
- Study start1 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Lina Bergman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469515
- Sponsor's protocol ID
- 2023-02089
- Other IDs
- 2023
- Acronym
- ECPON
- Status last verified
- Nov 2024
- First submitted
- 11 Jun 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bergman L, Zecevic E, Damen T, Markovic G, Martinik A, Saarijarvi M, Eckerblad J, Nilsson U. Exploring cognitive function and postoperative neurocognitive recovery after cardiac surgery in older adults (ECPON): a protocol for an observational study. BMJ Open. 2025 Jun 22;15(6):e098208. doi: 10.1136/bmjopen-2024-098208.
PubMed 40545303
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Continuity of Postoperative Care for Older People in Their Neurocognitive Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06469515
- Acronym / sponsor ID
- ECPON / 2023-02089
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jun 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.
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. Risk/affected factors such as delirium, functional status, recovery, depression, and healthcare-related quality of life, as well as close relative's 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:
- 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?
- 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?
- Is there any correlation between postoperative delirium and postoperative cognitive decline, and if so, which cognitive function is most affected?
- Which factors (such as age, operation time, perceived self-efficacy, frailty, and depression) affect the risk of suffering from postoperative cognitive decline?
- 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?
- How do older individuals experiencing cognitive symptoms and complaints perceive their postoperative recovery and return to daily life?
- How do close relatives perceive the patient's postoperative cognitive function, recovery, and return to everyday life, and how does this affect the relative's 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.
Descriptive data are presented with mean, median, frequency/proportion, 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of patients (65 years or older) who have undergone cardiac surgery and their relatives. The study participant is qualified for inclusion if he or she meets all the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (3 listed)
- Scheduled for elective or urgent open-heart surgery or minimally invasive cardiac surgery
- Resident in the area/region for the current thoracic clinic
- Able to read and understand Swedish
Key exclusion criteria (2 listed)
- Physical, mental, and cognitive difficulties that prevent the individual from completing the cognitive tests
- Undergone surgery within the last 6 months
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 |
|---|---|---|
| Elective or urgent cardiac surgeryThis is a longitudinal observational study to explore postoperative cognitive recovery among older persons (aged 65 or older) undergoing elective or urgent cardiac surgery via sternotomy. | Other | – |
Primary outcome
Postoperative cognitive complaints
Time frame: Before surgery and weekly up to three months after surgery
The Swedish Quality of Recovery cognitive version (SwQoR-Cog) is a self-assessment questionnaire that measures postoperative symptoms. The form consists of 14 statements regarding symptoms and discomforts, of which 11 address cognitive symptoms and 3 are related to pain and nausea. Symptoms and discomforts are rated on an 11-point scale (0=not at all to 10=all the time).
Changes in postoperative cognitive function, part 1
Time frame: Before surgery and 1, 3, and 6 months after surgery
Consortium to Establish a Registry for Alzheimer´s Disease (CERAD) A 10-word verbal learning test with 3 learning trials, a recall trial after ~7 min.
Changes in postoperative cognitive function, part 2
Time frame: Before surgery and 1, 3, and 6 months after surgery
Trail Making Test (TMT- A \& B) consists of 25 circles with letters or numbers on the screen.
Changes in postoperative cognitive function, part 3
Time frame: Before surgery and 1, 3, and 6 months after surgery
Stroop Colour-Word Test (SCW). 24 words spelling out the name of a colour which is printed in contrasting ink colours (e.g., the word "green" printed with red ink), and the participant is asked to tell the printed colour of the word rather than the word rather than the actual meaning of the word.
Changes in postoperative cognitive function, part 4
Time frame: Before surgery and 1, 3, and 6 months after surgery
Symbol Digits Processing Test (SDPT). The test consists of nine symbol-digit pairings at the top of the screen, one symbol in the middle of the screen, and a number grid at the bottom.
12 secondary outcomes
Postoperative delirium
Time frame: Twice daily up to postoperative day 7
Perceived self-efficacy
Time frame: Before surgery and 1, 3, and 6 months after surgery
Depressive symtoms
Time frame: Before surgery and 1, 3, and 6 months after surgery
Functional activity
Time frame: Before surgery and 1, 3, and 6 months after surgery
Frailty
Time frame: Before surgery and at 6 months after surgery
Fatigue
Time frame: Before surgery and at 6 months after surgery
Health-related quality of life as assessed by RAND-36
Time frame: Before surgery and at 6 months after surgery
Close relatives' assessment of cognition
Time frame: Before surgery and 1, 3, and 6 months after surgery
Caregiver burden
Time frame: Before surgery and 1, 3 and 6 months after surgery
Experiences of cognitive recovery
Time frame: At 6 months after surgery
Close relatives experience
Time frame: At 6 months after surgery
Unplanned healthcare visits
Time frame: At 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Derived from this study: PubMed 40545303Bergman L, Zecevic E, Damen T, Markovic G, Martinik A, Saarijarvi M, Eckerblad J, Nilsson U. Exploring cognitive function and postoperative neurocognitive recovery after cardiac surgery in older adults (ECPON): a protocol for an observational study. BMJ Open. 2025 Jun 22;15(6):e098208. doi: 10.1136/bmjopen-2024-098208.
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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.
Ulrica Nilsson, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Postoperative Recovery, run by Karolinska Institutet at 1 site in Sweden.
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 2 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: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Bergman, PhD (0046 8 524 836 66, lina.bergman@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive complaints (time frame: Before surgery and weekly up to three months after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06469515, which also lists 1 linked publication.
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 7 Nov 2024.