Cognitive Stimulation Therapy for Residents With Dementia in Long-Term Facilities: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
The goal of this experimental study was to evaluate whether cognitive stimulation therapy (CST) improved cognitive functioning and engagement levels in individuals with mild-to-moderate dementia residing in long-term care facilities. The study aimed to: 1) investigate the preliminary effect of CST on cognition and engagement in individuals with mild-to-moderate dementia, and 2) assess the feasibility of implementing CST in LTC facilities in the Cincinnati metropolitan area.
The main question the study answered was: Does CST improve cognitive functioning and increase engagement levels in individuals with mild-to-moderate dementia living in long-term care facilities?
Researchers conducted CST (structured, themed, grouped sessions with activites related to their childhood, sounds, word and number games, current affairs, being creative, word association, physical games, quizzes, and orientation) sessions to see if there was a significant increase in cognition and engagement after the 7 weeks of activites.
Participants received CST for 45 to 60 minutes twice weekly for 7 weeks, led by two doctor of occupational therapy students under the supervision of a licensed occupational therapist in the state of Indiana. Participants completed assessments before and after the 7-weeks to measure changes in cognitive function and engagement, along with participating in a screening assessment before the start of the study.
详细描述
This study was a quasi-experimental one group pretest-posttest designed to evaluate the significance of a 7-week CST program among residents of a long-term care facility with mild to moderate dementia. The primary aim was to investigate the preliminary effect of CST on cognition and engagement in individuals with mild-to-moderate dementia.
The study was conducted at Ridgewood Health Campus and aimed to enroll approximately 10 participants over an estimated period of 1 to 2 months. Recruitment was completed with one research team member meeting site staff, where she presented the study and prepared them to identify eligible individuals based on the inclusion criteria. Site staff then provided a list of potential participants and gave access to relevant medical records, which the research team reviewed before reaching out to potential participants and/or their legal representatives via email, phone, or in person.
Interested participants and their Powers of Attorney (POAs) received an informational handout explaining study expectations. If the POA expressed interest in participation, an electronic version of the informed consent form was provided and reviewed. Research team members were available to address questions via phone, email, Zoom, or in person. The signed consent forms were returned electronically or physically, and a copy was retained by the participant and/or their POA.
As 10 participants enrolled, they first completed a one-week screening period, followed by one week of pre-testing. The CST intervention was administered twice weekly for 45 minutes over 7 weeks, followed by a one-week post-intervention assessment period.
To ensure fidelity of the CST intervention, the Principal Investigator (PI) and Co-Investigators (Co-PIs) completed formal training through the North American Cognitive Stimulation Therapy Training Institute through Saint Louis University, School of Medicine. The CST practice manual was also followed strictly. The research team then collaborated closely with on-site staff to address concerns related to participant safety, treatment environment, or study procedures. In the event of an adverse event, the research team planned to follow all HIPAA and facility protocols and planned to report the incident to the PI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None (Participant, Outcomes Assessor)
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
- •Provide informed consent
- •Adults aged 18 years or older who reside in a long-term care facility
- •Adequate English proficiency, vision, hearing, and speech to participate in groups
- •English proficiency
- •participation in recreational or social activities for at least 45 minutes per week
- •diagnosis of mild-to-moderate dementia based on Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria, confirmed by medical records, or a mid-range score (18-55) on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
排除标准
- •Prior CST treatment
- •non-English speaking
- •Communication barriers (aphasia)
- •Diagnosis of severe dementia
- •History of a learning disability or traumatic brain injury
- •Participation in a concurrent clinical trial
- •Receiving hospice care
- •ADAS-Cog score in the no-impairment range (0-17) or high range (56-70).
研究组 & 干预措施
Cognitive stimulation therapy group
The CST group will participate in a screening measure where they will perform the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) to assess for cognitive impairment. The participants will then participate in the Montreal Cognitive Assessment (MoCA) and the Observational Measurement of Engagement (OME) prior to and after the 7-week CST program. The group will receive CST, which is an evidence-based, cognitively stimulating therapeutic group intervention, two times per week for 7 weeks for 45 minutes. The general structure of each session will follow the CST Manual called "Making a Difference 1" and each participant will participate in an introduction, theme song, current affairs activity, the main activity (theme-based activities), and closure each session.
干预措施: Cognitive Stimulation Therapy (Other)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions (week of August 18th).
The MoCA assesses multiple areas of cognition such as attention, orientation, delayed recall, working memory, executive functioning, visuospatial, and language. The MoCA will take approximately 10 minutes to administer. MoCA scores range from 0 to 30, with higher scores indicating better cognitive functioning. Scores between 10 and 25 typically reflect mild to moderate cognitive impairment, and a score within this range is required for study inclusion. Therefore, only participants scoring between 10 and 25 at baseline will be enrolled, and we will assess whether their cognitive functioning improves from this initial range over the seven weeks.
The Observational Measurement of Engagement - OME Modified
时间窗: From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions (week of August 18th).
The OME is a measurement tool used for individuals with dementia to document direct observations regarding their level of engagement during an activity. The OME assesses an individual's response to the stimuli during an activity by taking note of their attention and attitude using a rating scale. The OME also assesses the individual's cognitive and fine motor difficulty during the task, as well as, the duration and frequency of interactions in the task to determine overall engagement. The OME will take between 3 and 15 minutes to administer. Three minutes if the participant is disengaged with the stimulus and 15 minutes if the participant is engaged the entire time. The OME Modified scoring system includes variable ranges depending on the domain assessed. For attitude and attention, scores range from 1 to 7, with higher scores indicating better outcomes. For activity, scores range from 0 to 3, where a score of 3 represents a greater time the participant was manifesting the activites.
Montreal Cognitive Assessment (MoCA)
时间窗: From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions (week of August 18th).
The MoCA assesses multiple areas of cognition such as attention, orientation, delayed recall, working memory, executive functioning, visuospatial, and language. The MoCA will take approximately 10 minutes to administer. MoCA scores range from 0 to 30, with higher scores indicating better cognitive functioning. Scores between 10 and 25 typically reflect mild to moderate cognitive impairment, and a score within this range is required for study inclusion. Therefore, only participants scoring between 10 and 25 at baseline will be enrolled, and we will assess whether their cognitive functioning improves from this initial range over the seven weeks.
The Observational Measurement of Engagement - OME Modified
时间窗: From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions (week of August 18th).
The OME is a measurement tool used for individuals with dementia to document direct observations regarding their level of engagement during an activity. The OME assesses an individual's response to the stimuli during an activity by taking note of their attention and attitude using a rating scale. The OME also assesses the individual's cognitive and fine motor difficulty during the task, as well as, the duration and frequency of interactions in the task to determine overall engagement. The OME will take between 3 and 15 minutes to administer. Three minutes if the participant is disengaged with the stimulus and 15 minutes if the participant is engaged the entire time. The OME Modified scoring system includes variable ranges depending on the domain assessed. For attitude and attention, scores range from 1 to 7, with higher scores indicating better outcomes. For activity, scores range from 0 to 3, where a score of 3 represents a greater time the participant was manifesting the activites.
次要结局
未报告次要终点
研究者
Abigail Genevieve Halsey
Doctor of Occupational Therapy Student
Northern Kentucky University