Feasibility Randomised Controlled Trial (RCT) of Advanced Cognitive Stimulation Therapy (ACST) for People With Moderate to Severe Dementia
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Recruitment (feasibility of ACST)
研究概览
简要总结
This study is a feasibility randomised controlled trial (RCT) for an evidence-based intervention for people with moderate to severe dementia. The psychosocial intervention is adapted from Cognitive Stimulation Therapy (CST) and developed within the Medical Research Council (MRC) framework.
详细描述
The World Health Organization calls for an increase of psychosocial interventions for dementia-a global epidemic. Cognitive Stimulation Therapy (CST) is the only non-pharmacological therapy recommended by the National Institute for Health and Care Excellence for improving cognition for mild to moderate dementia. However, there is little guidance on how to maximise cognition for severe dementia. Advanced Cognitive Stimulation Therapy (ACST) will be the first evidence-based complex intervention for moderate to severe dementia developed within the Medical Research Council (MRC) framework and building upon CST's key principles. This feasibility randomised controlled trial (RCT) aims to 1) evaluate the feasibility of ACST 2) explore if ACST can improve the cognitive function, and QoL, as well as other outcomes including behaviour, engagement, and communication, for people with moderate to severe dementia. A sample of 32 participants will be recruited, where 16 will be randomly allocated to ACST, and 16 to treatment as usual (TAU). Data will be collected pre and post the 7-week intervention period. Improving cognition and QoL for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-blind. Assessor will be blinded to the study. Due to the nature of the intervention, the facilitator and participants cannot be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dementia, according to the DSM-IV
- •Ability to communicate in English
- •Ability to complete outcome measures
- •Not having major physical illness or disability that affects participation
- •Consultee is willing and able to provide written informed consent if the participant is not able to provide consent.
- •Ability to remain in a group for around an hour (e.g. no challenging behaviour)
排除标准
- •Illness and disability that affects participation (as deemed by the researcher or attending care home staff)
- •Participation in other psychosocial intervention studies
结局指标
主要结局
Recruitment (feasibility of ACST)
时间窗: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Feasibility of recruitment by successful recruitment of the target sample of 32 in a 24-month period.
Negative or adverse events (acceptability of ACST)
时间窗: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Any negative or adverse events related to the intervention
Retention rate (feasibility of ACST)
时间窗: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Retention rate of at least 75% of participants at 8-week follow-up.
Intervention fidelity (acceptability of ACST)
时间窗: Descriptive data will be collected during the study and analysed post-intervention; through study completion, 2 years
Facilitator's completion of the fidelity checklist following each session
次要结局
- Change in overall well-being(Evaluated by assessor through video recordings for every session; through study completion, 2 years)
- Change in quality of life(Pre test (baseline: week 0) and post test (week 8))
- Change in engagement(Evaluated by facilitator after every other session, and independent researcher through recordings; through study completion, up to 24-months)
- Change in cognitive function(Pre test (baseline: week 0) and post test (week 8))
- Change in behaviour(Pre test (baseline: week 0) and post test (week 8))
- Change in communication abilities(Pre test (baseline: week 0) and post test (week 8))