Computer-assisted Cognitive Stimulation Treatment for Delirium (Delitract)
Clinical, Demographic and Genetic Factors Associated With Response to Computer-assisted Cognitive Stimulation Treatment as Part of Non-pharmacological Care in Patients With Delirium. Feasibility Study.
The objectives of our study are to determine whether people with delirium in a subacute care unit improve after one week with non-pharmacological therapies based on improving sleep schedules, mobility, and cognitive stimulation (such as memory, attention, orientation, among others), and to compare two groups of people who will receive slightly different therapies.
We will try to determine whether individual characteristics (such as diagnosed diseases, blood test results or genetics, gender, age, educational level, among others) influence the onset of an episode of delirium, its severity and its response to treatment.
Participants with delirium will be divided into two groups that will receive:
- The non-pharmacological treatment described
- One group will also receive a specific cognitive intervention from an occupational therapist, using a computer programme on a tablet, twice a day for one week.
After one week, the presence and severity of delirium will be reassessed.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Esteban Sepulveda-Ramos, PhD
- 电话号码:+34-977338565
- 邮箱:esteban.sepulveda@urv.cat
学习地点
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Tarragona
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Reus、Tarragona、西班牙、43206
- 招聘中
- Institut Pere Mata
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接触:
- Esteban Sepulveda-Ramos, PhD
- 电话号码:+34-669900887
- 邮箱:esteban.sepulveda@urv.cat
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- All patients aged 60 years or over who are admitted to the subacute care center between 15 February and 15 October 2026 and who sign the informed consent (the patient and their family or legal guardians if the patient's cognitive condition prevents them from giving consent themselves)
Exclusion Criteria:
- Patients who, at the time of admission, meet the criteria for palliative end-of-life care.
- Individuals under 60 years of age, to ensure sample homogeneity and reduce confounding factors.
- Individuals with severe visual or hearing impairment or aphasia, due to the difficulty of carrying out the cognitive intervention.
- Serious communication difficulties due to language.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Computer-based cognitive intervention
Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet.
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Specific cognitive stimulation intervention using a tablet, administered by the occupational therapist, with the aim of carrying out two interventions each day: one in the morning and one in the afternoon.
Each intervention will vary in duration, depending on the person's clinical condition, but will not exceed 20 minutes.
Each person will receive the intervention for a period of one week from the diagnosis of delirium, corresponding to five working days.
The intervention will focus on three cognitive aspects that are part of the core symptoms of delirium: attention, orientation and visuospatial ability.
Participants will undergo a comprehensive geriatric assessment and will be prescribed multidisciplinary treatment according to the clinical criteria of the centre's professionals, in order to address the underlying condition for which the patient has been admitted to the centre and any associated comorbidities. The guidelines for pharmacological and non-pharmacological treatment of delirium included in the centre's clinical guidelines will be followed. With regard to the non-pharmacological treatment of delirium, specific measures will be taken for:
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有源比较器:Usual care intervention
Participants will receive the usual non-pharmacological measures, with emphasis on three groups: guidance, cognitive stimulation and visuospatial measures, early active mobility, and recovery of the sleep-wake cycle.
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Participants will undergo a comprehensive geriatric assessment and will be prescribed multidisciplinary treatment according to the clinical criteria of the centre's professionals, in order to address the underlying condition for which the patient has been admitted to the centre and any associated comorbidities. The guidelines for pharmacological and non-pharmacological treatment of delirium included in the centre's clinical guidelines will be followed. With regard to the non-pharmacological treatment of delirium, specific measures will be taken for:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical changes in delirium
大体时间:Baseline and one week after enrollment
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The overall severity of delirium and of each of its symptoms will be assessed using the Delirium Rating Scale-Revised-98 (DRS-98) by psychiatrists at the time of admission and after one week, in order to determine changes in its clinical manifestations.
The DRS-98 includes phenomenological descriptors to assess the severity levels of each of its 16 items (ranging from 0 to 3, indicating from absence to maximum severity).
Scores on the total scale range from 0 to 46 points (items 1 to 16) and from 0 to 39 points on the severity scale (items 1 to 13), indicating from the absence to the maximum severity of symptoms.
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Baseline and one week after enrollment
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The presence and severity of delirium and its core symptoms
大体时间:Baseline and one week after enrollment
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The presence and severity of global delirium and of three of its symptoms corresponding to its core domains, assessed using the Delirium Diagnostic Tool-Provisional (DTT-Pro) administered by general practitioners at the time of admission and one week later, in order to determine changes in clinical manifestations.
Each item is scored on a Likert scale ranging from zero (maximum severity) to three (no abnormality), with nine being the highest possible score and zero the lowest possible score.
The recommended cut-off score is ≤6 for delirium and ≤7 to also identify patients with subsyndromic delirium.
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Baseline and one week after enrollment
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Presence of delirium according DSM-5 criteria
大体时间:One week after enrollment
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Psychiatrists will assess for the presence of delirium according to the DSM-5 criteria at the time of admission and one week later, in order to determine whether the diagnosis still applies after one week.
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One week after enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Psychopharmacological treatment during the first week
大体时间:From enrollment to the end of the intervention in one week
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We will record whether the individual has been prescribed any of the following types of medication: antipsychotics, benzodiazepines, anticholinergics, opioids and antidepressants.
We will note whether these were prescribed on admission, during the follow-up period or at the end of the follow-up period.
We will record the generic name and daily dose of each medication, in accordance with the internationally accepted units of measurement for each medication.
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From enrollment to the end of the intervention in one week
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Changes in functional independence in activities of daily living
大体时间:Upon enrollment and one week later
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Functional independence in activities of daily living will be assessed on admission and one week later, using the Barthel Index.
The Barthel Index uses a rating scale to score performance across 10 aspects, with total scores ranging from 0 to 100.
A higher score indicates greater independence.
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Upon enrollment and one week later
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Change in fall risk
大体时间:Upon enrollment and one week later
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The fall risk will be assessed on admission and one week later using the Tinetti test, which has a minimum score of 0 and a maximum score of 28 (the lower the score, the higher the fall risk).
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Upon enrollment and one week later
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Change in ability to walk unassisted
大体时间:Upon enrollment and one week later
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The patient's walking ability prior to the acute episode that led to admission will be assessed on admission and again one week later using the Functional Ambulation Category (FAC) scale, where a score of 5 indicates the ability to walk unaided and a score of 0 indicates an inability to walk.
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Upon enrollment and one week later
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Relevant clinical events
大体时间:From admission to the first week
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We will record clinical events such as the need for referral to A&E, death, falls, the use of physical restraints, new diagnoses or other significant occurrences.
These will be recorded in free text format for subsequent classification.
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From admission to the first week
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Adherence to and follow-up of non-pharmacological measures
大体时间:From admission to the first week
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We will assess participants' ability and willingness to adhere to non-pharmacological measures, both specific cognitive ones and general ones.
These will be recorded in an open-ended format for subsequent classification.
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From admission to the first week
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Delitract
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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