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临床试验/NCT03342989
NCT03342989终止不适用

Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
2
主要终点
General Cognitive Performance Battery

研究概览

简要总结

In this proposal, we will examine processing speed training (PST) as a potential intervention to reduce the risk of developing long-term cognitive impairment after a delirium episode.

详细描述

The overall goal of this project is to measure longitudinal cognitive function among hospitalized older adults after an episode of delirium, and examine an intervention (processing speed training, or PST) to slow the rate of cognitive decline that occurs after an episode of delirium compared to an Internet-based control condition (INT). We will initially recruit a cohort of 136 subjects who have experienced delirium, provide PST or INT training to them, and assess them on measures of cognition and instrumental activities of daily living (IADLs) after training and every 6 months thereafter for 24 to 36 months. We will perform a preliminary determination of the efficacy of PST after these 136 subjects have completed training, testing whether subjects receiving PST have better cognitive test scores immediately after training compared to subjects receiving INT. Assuming this preliminary test of efficacy shows short-term benefits for PST, we will recruit an additional 280 subjects who have experienced delirium and provide PST training to them. We will follow all 416 subjects for 24 to 36 months after their delirium episode to test whether subjects receiving PST have slower rates of decline over time compared to subjects receiving INT on measures of cognition and IADLs. A more detailed timeline of study procedures follows.

In Hospital (Month 0): We will initially identify subjects with delirium from the inpatient medical units at UAB Hospital. As part of UAB's Virtual ACE quality improvement project, nurses on the medical units administer the Nursing Delirium Screening Scale (NUDESC) to screen for delirium in all patients age ≥ 65 on admission and once per shift thereafter. After obtaining informed consent, we will collect a range of measures from the subject and family to make the diagnosis of delirium and rate its severity, as well as measures examining comorbidities potentially contributing to delirium. These measures for assessing delirium will be

  • the NUDESC ratings from the medical record;
  • the Confusion Assessment Method (CAM), a standard clinician-rated instrument for the diagnosis of delirium;
  • the Delirium Symptom Interview (DSI), an interview administered by a clinician to standardize the assessment of delirium symptoms for rating the CAM;
  • the Cognitive Test for Delirium (CTD), a general measure of cognition used to standardize the assessment of cognitive symptoms for rating the CAM;
  • the Family Confusion Assessment Method (FAMCAM), which assesses the family's observation of symptoms of delirium (although this will not be required for delirium diagnosis);
  • the chart-based review method for delirium (CHART-DEL), which collects information from the medical records about signs and symptoms that can indicate delirium;
  • the Delirium Etiology Rating Checklist (DERC), a clinician-rated instrument that categorizes the different potential causes of delirium for the subject, based on information in the medical record on other medical conditions, current medications, neuroimaging (CT or MRI, if available), abnormal laboratory values (complete blood count, serum electrolytes and chemistries, liver function tests, and urine drug screen, if available);
  • the Anticholinergic Burden Scale (ABS), which rates the contribution of the subject's medications to their episode of delirium.

Additional measures collected on comorbidities and factors affecting delirium will be

  • demographics (age, race, gender);
  • the AD8 and the Modified Blessed Dementia Rating Scale, which assess the family's observations of symptoms of dementia that preceded the episode of delirium;
  • the Charlson Comorbidity Index (CCI), which assesses the presence of other medical conditions beyond delirium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking (English need not be first language);
  • admission to the inpatient medical wards at University of Alabama at Birmingham Hospital;
  • positive screen for delirium, defined as a score ≥ 1 on the Nursing Delirium Screening Scale, during hospitalization;
  • presence of delirium, defined using the Confusion Assessment Method, during hospitalization;
  • informant-rated AD8 score ≤ 6;
  • living within 40 miles of the Birmingham, Alabama metro area.

排除标准

  • active delirium at the time of baseline assessment after hospital discharge, defined using the Confusion Assessment Method;
  • hospitalization in the previous 3 months prior to the index hospitalization;
  • terminal condition with life expectancy < 6 months;
  • inability to perform cognitive tests due to poor vision or hearing at baseline assessment;
  • history of schizophrenia or other psychotic disorder;
  • alcohol withdrawal delirium during hospitalization, history of alcohol abuse, or history of alcohol withdrawal in the previous 6 months;
  • unable to provide informed consent at baseline visit (proxy consent may be used for in-hospital assessments).

结局指标

主要结局

General Cognitive Performance Battery

时间窗: 24 Month Follow-up

Composite Neuropsychological Test Battery

次要结局

  • Timed Instrumental Activities of Daily Living(24 Month Follow-up)
  • Incident Dementia(24 Month Follow-Up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Kennedy

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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