Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: RehaCom.
- Кому может быть актуально
- Состояния в реестре: COVID-19, Cognitive Impairment, Cognition Disorder, Memory Disorders. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effectiveness of Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
Обзор
Many post COVID-19 patients suffer from cognitive deficits, even after 1 year after hospitalization. These complaints have a huge impact on psychological well-being and quality of life. In rehabilitation programs in the Netherlands, most interventions are based on physical therapy or learning how to cope with fatigue and low levels of energy. In former studies computerized training of cognition in other populations has been proven to be effective. Knowledge on the effect of computerized training on attention and working memory in patients suffering from COVID-19 is urgently needed, and may contribute to more evidence-based rehabilitation programs for these patients. Therefore the effectiveness of computerized training of attention and working memory in post COVID-19 patients with cognitive complaints will be studied in this study.
Подробное описание
Since 2019, the world has been overwhelmed by COVID-19, a respiratory infectious disease. Current evidence suggests that approximately 10%-20% of people experience symptoms of post COVID-19 condition. Many post COVID-19 victims suffer from fatigue, cognitive deficits and / or subjective cognitive complaints, even after 1 year after hospitalization. Detailed research shows deficits in attention, both in sustained and executive components. Furthermore, less capacity of working memory, inhibition deficits and lower information processing speed is frequently reported. Fatigue and cognitive impairment have been consistently reported to be some of the most common and debilitating features of post COVID-19 condition. Like fatigue, cognitive complaints are associated with anxiety and depression and have an impact on every day functioning, return to work and account for diminished health-related quality of life (HR-QoL). There are no established and effective treatments yet for these patients. In former studies computerized training in other populations has been proven to be effective. Knowledge on the effect of computerized training on attention and working memory in patients suffering from COVID-19 is urgently needed, and may contribute to more evidence-based rehabilitation programs.
Objective: The primary aim of this study is to evaluate the effect of a computerized cognitive rehabilitation program (RehaCom) in post COVID-19 patients with cognitive complaints. The secondary aim is to evaluate the effect of this computerized cognitive rehabilitation program on subjective cognitive complaints, psychological outcome measures and HR-QoL and to assess the feasibility of the program.
Study design: Randomized wait-list controlled pilot trial.
Study population: Participants of the multicentre prospective cohort study CO-FLOW (NL74252.078.20) suffering from persistent cognitive complaints after 2 years after hospitalization as measured with the Cognitive Failure Questionnaire (CFQ ) will be invited.
Intervention: Computerized cognitive training, 10 weeks, 3 times/week 15 - 30 minutes/session.
Main study parameters/endpoints: Cognitive functioning (attention and working memory) and psychological functioning (coping, anxiety, depression) and HR-QoL, using non-invasive neuropsychological tests and standardized online questionnaires. All outcomes will be assessed pre- and post-intervention and at 3 and 6 months follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The intervention is an online cognitive rehabilitation program, 3 times a week 15 - 30 minutes per session during 10 weeks. Participants can choose what time of the day is most convenient for them to engage in the program in their home environment. They might improve their attention and working memory, and therefore may also improve quality of life.
Personal and disease characteristics are copied from patient records collected in the CO-FLOW study and additional measurements are non-invasive and minimally physically demanding.
Completion of online questionnaires, additional neuropsychological measurements and joining the intervention require a certain time investment from patients and might lead to temporary fatigue. By a maximum duration of 30 minutes per session for online questionnaires and neuropsychological tests we aim to minimize the burden for patients.
Вмешательства
- Устройство RehaCom
computerized cognitive training
Первичные конечные точки
- General cognition [Срок оценки: 3 months]
- Attention [Срок оценки: 6-9 months]
- Working memory [Срок оценки: 6-9 months]
Вторичные конечные точки (6)
- Subjective cognitive complaints [Срок оценки: 6-9 months]
- Anxiety and depression [Срок оценки: 6-9 months]
- Health-related quality of life (HR-QoL) [Срок оценки: 6-9 months]
- Fatigue [Срок оценки: 6-9 months]
- Coping [Срок оценки: 1 month]
- Personality traits neuroticism and extraversion [Срок оценки: 1 month]
Критерии участия
Критерии включения
- aged 18 years and older;
- patient has sufficient knowledge of Dutch language;
- CFQ> 43 at 2 year follow-up of CO-FLOW, indicating persistent cognitive complaints;
- Computer and internet-access.
Критерии исключения
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Incapacitated patients like patients diagnosed with dementia;
- Patients should not be involved in concurrent rehabilitation program, cognitive behavioural therapy or psychotherapy targeting cognition, anxiety and/or depression.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 1 центр
- Rijndam Rehabilitation — Rotterdam
Идентификаторы
NCT: NCT05831839 · NL84105.078.23