Clinical trial NCT06469515: Older People's Neurocognitive Recovery After Cardiac Surgery
Official title: Enhanced Continuity of Postoperative Care for Older People in Their Neurocognitive Recovery After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Cognitive Dysfunction
Postoperative Recovery
Cardiac Surgery
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2024-06-21
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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. 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:

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Physical, mental, and cognitive difficulties that prevent the individual from completing the cognitive tests
* Undergone surgery within the last 6 months

Primary outcomes:
measure: Postoperative cognitive complaints
timeFrame: Before surgery and weekly up to three months after surgery
measure: Changes in postoperative cognitive function, part 1
timeFrame: Before surgery and 1, 3, and 6 months after surgery
measure: Changes in postoperative cognitive function, part 2
timeFrame: Before surgery and 1, 3, and 6 months after surgery
measure: Changes in postoperative cognitive function, part 3
timeFrame: Before surgery and 1, 3, and 6 months after surgery
measure: Changes in postoperative cognitive function, part 4
timeFrame: Before surgery and 1, 3, and 6 months after surgery
Secondary outcomes:
measure: Postoperative delirium
timeFrame: Twice daily up to postoperative day 7
measure: Perceived self-efficacy
timeFrame: Before surgery and 1, 3, and 6 months after surgery
measure: Depressive symtoms
timeFrame: Before surgery and 1, 3, and 6 months after surgery
measure: Functional activity
timeFrame: Before surgery and 1, 3, and 6 months after surgery
measure: Frailty
timeFrame: Before surgery and at 6 months after surgery
measure: Fatigue
timeFrame: Before surgery and at 6 months after surgery
measure: Health-related quality of life as assessed by RAND-36
timeFrame: Before surgery and at 6 months after surgery
measure: Close relatives' assessment of cognition
timeFrame: Before surgery and 1, 3, and 6 months after surgery
measure: Caregiver burden
timeFrame: Before surgery and 1, 3 and 6 months after surgery
measure: Experiences of cognitive recovery
timeFrame: At 6 months after surgery
measure: Close relatives experience
timeFrame: At 6 months after surgery
measure: Unplanned healthcare visits
timeFrame: At 6 months after surgery
Other outcomes:
measure: Demographic and perioperative data
timeFrame: At baseline and perioperatively
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References: