Older People's Neurocognitive Recovery After Cardiac Surgery
NCT Number: NCT06469515
Acronym: ECPON
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Postoperative Cognitive Dysfunction|Postoperative Recovery|Cardiac Surgery
Interventions: OTHER: Elective or urgent cardiac surgery
Sponsor: Karolinska Institutet
Collaborators: Sahlgrenska University Hospital, Sweden
Sex: ALL
Age: OLDER_ADULT
Enrollment: 220
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-12

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.

Primary Outcome Measures: 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)., 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., 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., 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., 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., Before surgery and 1, 3, and 6 months after surgery
Secondary Outcome Measures: Postoperative delirium, alternative 1, 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., Twice daily up to postoperative day 7|Postoperative delirium, alternative 2, The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is an assessment form consisting of observations, as well as the patient performing a letter test and answering questions. The assessment results in either a positive or negative outcome., 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., 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., 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., 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., 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., 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., 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)., 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)., Before surgery and 1, 3 and 6 months after surgery|Experiences of cognitive recovery, Qualitative semi-structured interviews, At 6 months after surgery|Close relatives experience, Qualitative semi-structured interviews, At 6 months after surgery|Unplanned healthcare visits, Study-specific questionnaire where participants will register any unplanned contacts or visits with healthcare services., At 6 months after surgery
Other Outcome Measures: Demographic and perioperative data, Will be collected from the medical record., At baseline and perioperatively