Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Cognitive Impairment
研究概览
简要总结
Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. This pilot pragmatic trial will embed CST referral into the standard care protocol of health care settings that serve people living with dementia in the state of Connecticut, and evaluate online delivery of CST known as virtual CST (V-CST), and assess the acceptability of V-CST to people living with dementia.
The study design is a two-armed randomized embedded pragmatic clinical trial (ePCT). The trial aims to determine if cognitive decline is experienced less commonly among V-CST participants than control group members based on three widely used measures of cognition, the Montreal Cognitive Assessment (MoCA), St. Louis University Memory Screen (SLUMS), and Mini Mental State Exam (MMSE).
The study population will be persons with mild to moderate dementia identified by clinicians in standard care. From this population, subject participants will be randomized to intervention and control groups. Patients randomly assigned to the intervention group will be referred by their clinical providers to participate in V-CST, and those who accept the referral will participate in the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Mild Cognitive Impairment or Mild to Moderate Dementia
- •MoCA score of 10 to 26 OR SLUMS score of 10 to 26 OR MMSE score between 13 and 24 recorded as present < 24 months before the record review
- •English-speaking
- •Visit scheduled to include cognitive screening 6 to 12 months after record review.
排除标准
- •Auditory or visual impairment, combative behaviors, or other clinician-assessed condition that would interfere with group treatment
- •No access to online meeting platform
- •Patient has specified to HCS not to engage patient in research or to use patient data in research
- •Patient has previously participated in V-CST
- •Physician determines a caregiver is needed to support V-CST participation, but no caregiver available to assist with technology.
结局指标
主要结局
Cognitive Impairment
时间窗: 12 months
Cognitive Impairment was assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' was used to convert all cognitive assessment measures to a MoCA score. MoCA scores range from 0-30, with 26+ generally considered normal, while scores below that suggest cognitive issues: 18-25 is often mild impairment, 10-17 is moderate, and under 10 is severe impairment. All participants started with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment.
次要结局
- Percentage of Participants Who Accepted the Referral(1 month)
- Percentage of Participants Who Completed Cognitive Stimulation Therapy(7 weeks)
- Percentage of Participants Who Did Not Complete CST(7 weeks)
研究者
Michael Lepore
Professor
University of Massachusetts, Amherst