Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
研究概览
简要总结
This project aims to examine the feasibility of implementing Cognitive Stimulation Therapy (CST) under real world circumstances in a more heterogenous population, with the ultimate goal of making the treatment broadly accessible. The effects of CST on the behavioral and psychological symptoms of dementia (BPSD) as a non-pharmacologic intervention will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •established diagnosis of dementia or meets the criteria for dementia based on a positive screening test with clinical evidence of cognitive impairment affecting one or more ADL
- •has a SLUMS score greater than 10.
排除标准
- •unable to hold a meaningful conversation,
- •unable to hear well enough to participate in a small group discussion
- •severe visual impairment that precludes ability to see most pictures
- •unable to remain in a group setting for 45 minutes
结局指标
主要结局
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation
时间窗: 2 years
Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)
时间窗: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A 5-point scale measuring general well-being/quality of life for older adults
Maintenance as measured by percentage of long-term attrition
时间窗: 2 years
Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia
时间窗: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory
时间窗: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Assess the barriers and facilitators to implementation of CST in community settings
时间窗: 1 year
Focus groups will be held to better understand the barriers and facilitators to adoption at both the setting level and individual level. These focus groups will also be used to assess implementation by gathering data on adherence to the prescribed CST protocol and any adaptations made to the CST intervention. Implementation fidelity will be assessed by direct observation of the CST groups by members of the research team using a checklist to describe adherence to key components of the protocol. Implementation barriers will be assessed through the use of focus groups and questionnaires. Based on collected data on implementation barriers and process measures, we will develop strategies to improve fidelity of the intervention and to enhance reach.
Adoption as measured by the percentage of non-participating centers to the total number approached.
时间窗: 2 years
Change in cognitive status as measured by Saint Louis University Mental Status Examination
时间窗: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
A validated 30 point office-based cognitive screen
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.
时间窗: 1 year
次要结局
未报告次要终点