Enhanced Continuity of Postoperative Care for Older People in Their Neurocognitive Recovery After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Changes in postoperative cognitive function, part 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Physical, mental, and cognitive difficulties that prevent the individual from completing the cognitive tests
- •Undergone surgery within the last 6 months
结局指标
主要结局
Changes in postoperative cognitive function, part 3
时间窗: 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 2
时间窗: 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.
Postoperative cognitive complaints
时间窗: 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
时间窗: 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 4
时间窗: 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.
次要结局
- Postoperative delirium(Twice daily up to postoperative day 7)
- Perceived self-efficacy(Before surgery and 1, 3, and 6 months after surgery)
- Depressive symtoms(Before surgery and 1, 3, and 6 months after surgery)
- Functional activity(Before surgery and 1, 3, and 6 months after surgery)
- Frailty(Before surgery and at 6 months after surgery)
- Fatigue(Before surgery and at 6 months after surgery)
- Health-related quality of life as assessed by RAND-36(Before surgery and at 6 months after surgery)
- Close relatives' assessment of cognition(Before surgery and 1, 3, and 6 months after surgery)
- Caregiver burden(Before surgery and 1, 3 and 6 months after surgery)
- Experiences of cognitive recovery(At 6 months after surgery)
- Close relatives experience(At 6 months after surgery)
- Unplanned healthcare visits(At 6 months after surgery)
研究者
Lina Bergman
Principal Investigator
Karolinska Institutet