5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,201
- 试验地点
- 1
- 主要终点
- New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals.
研究概览
简要总结
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. The investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the technical, cultural and logistic barriers of current cognitive screens to improve dementia care in primary care patients with cognitive concerns.
详细描述
Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings, and is a more prevalent problem among older African-Americans and Hispanics than among older whites. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. To overcome the technical, cultural and logistic barriers of current cognitive screens and dementia care in primary care settings the investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to identify persons at high risk of developing dementia in multi-ethnic primary care populations.
The 5-Cog includes the Picture based Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and a brief non-memory picture based test (Symbol Match). The cognitive assessment will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. It is coupled with a decision tree to guide clinicians through the follow up based on results of the 5-Cog.
The primary objective is to test the ability of the 5-Cog and decision tree paradigm to improve dementia care in primary care patients with cognitive concerns.
The investigators propose a single-blind, randomized clinical trial (RCT) in 1,200 older primary care patients with cognitive concerns who will be randomized to receive the 5-Cog (intervention group) or a 5-minute health literacy and grip assessment (active control group). Non-physicians will administer the intervention and control assessments in primary care sites and will provide results for both arms to the treating physician with a decision tree follow up guide based on the results of the assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (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
- 是
入选标准
- •Age 65 and older.
- •Presence of cognitive or memory concerns expressed by patient, caregiver, health care provider or other source who knows the patient.
- •Registered as patient at Montefiore Medical Center and have a primary care doctor appointment that day.
- •Able to hear and see well enough to complete intervention or control assessments.
- •English or Spanish speaking.
排除标准
- •Prior diagnosis of dementia or MCI as ascertained by ICD-10 codes or the documentation of prescription for anti-dementia medications in EMR. Patients with a diagnosis containing any of the following terms will be excluded:
- •"Mild Cognitive Impairment"
- •"Alzheimer's Disease"
- •"Creutzfeldt-Jakob Disease"
- •"Major Neurocognitive Disorder"
- •"Minor Neurocognitive Disorder"
- •Patients with any of the following medications documented in their EMR will be excluded (generic = brand):
- •Donepezil = Aricept
- •Memantine = Namenda
- •Rivastigmine = Exelon
- •Galantamine = Razadyne
- •Donepezil and Memantine = Namzaric
- •Adults who are permanent residents of a nursing facility.
- •Patients who do not speak English or Spanish.
- •Patients who are not seeing a primary care physician at the clinic that day.
- •Patients who are blind or deaf or cannot hear loud voice even with hearing aids.
研究组 & 干预措施
5-Cog
The 5-Cog coupled with a decision tree is a simple, 5-minute procedure that will identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. The 5-Cog includes the Picture Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and the Symbol Match test. The 5-Cog will be given after randomization and before the patients sees the physician. The 5-Cog will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. After completing the 5-Cog, the non-physician tester will send a message through the Electronic medical record (EMR) system to provide the physician with the 5-Cog results and guide the them through the follow-up based on the results.
干预措施: 5-Cog (Other)
Health Literacy & Grip Assessment
The 5 minute assessment includes the Short Assessment of Health Literacy (SAHL) and a grip assessment measured using a handgrip dynamometer. After completing the SAHL and grip assessment, the non-physician tester will send a message through the EMR to provide the physician with the results from the assessments and guide the them through the follow-up based on the results.
干预措施: Health Literacy & Grip Assessment (Other)
结局指标
主要结局
New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals.
时间窗: 90 days after the participant is randomized
Dementia care is defined as the occurrence of any of the following endpoints following the screening visit. The endpoint is the number of participants who received 1 or more of the following orders: 1. Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR. 2. Tests ordered for reversible causes of cognitive impairment as recommended by the published guidelines of professional societies (i.e. thyroid function tests, B-12 level, Syphilis Panel, human immunodeficiency virus (HIV) test, computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans) documented in the EMR. 3. Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR. 4. Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR.
次要结局
- New Occurrence of in Health Care Utilization(6 months after the participant is randomized)