Cognitive Stimulation in Activities of Daily Living for Individuals Living With Mild-to-Moderate Dementia (CS-ADL): a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from baseline in the performance of activities of daily living (ADL) of participants
研究概览
简要总结
The goal of this study is to test the effect of CS-ADL is on people living with early to middle stage dementia. The study also aims to evaluate the feasibility of conducting larger-scale research of CS-ADL.
The main questions it aims to answer are:
- What is the effect of CS-ADL on the ability of people with early to middle stage dementia to carry out their everyday activities?
- What is the effect of CS-ADL on the memory, mood, communication, and quality of life of people living with early to middle stage dementia? What is the feasibility of conducting large-scale research of CS-ADL?
Participants will take part in a group program that lasts 7 weeks, with one session per week, lasting two hours. Participants will take part in rewarding and stimulating activities, for example discussion, reminiscence, music, and practical activities such as baking, cooking, gardening. Participants will be asked to complete a variety of questionnaires before and after taking part in the group.
Researchers will compare a group receiving CS-ADL to a group receiving their usual care, to explore whether CS-ADL works well in comparison to typical treatment provided by the health services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will be blinded to group allocation where possible.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a formal diagnosis of major neurocognitive disorder (dementia) as per the DSM-V criteria.
- •Participants must have a mild-to-moderate cognitive impairment as classified by the Montreal Cognitive Assessment (MoCA).
- •Participants must have some ability to communicate and understand communication, determined by a score of 1 or 0 on questions 12 and 13 of the Clifton Assessment Procedures for the Elderly-Behaviour Rating Scale.
- •Participants must be able to see and hear well enough to participate in the group.
排除标准
- •Individuals with severe dementia, i.e., an MMSE<10, will be excluded as most CS interventions are not applicable for those with severe cognitive impairment.
- •Participants will be excluded if they have significant uncontrolled disruptive behaviours.
- •Premorbid diagnosis of a learning disability.
- •A significant physical illness/disability that may affect participation during intervention sessions or assessments.
结局指标
主要结局
Change from baseline in the performance of activities of daily living (ADL) of participants
时间窗: This will be administered at baseline (week 0), and post-intervention (week 8).
ADL performance will be measured using the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. This scale was designed for the assessment of ADL outcomes for individuals with Alzheimer's disease in clinical trials. The scale consists of 23 items that includes 6 BADL and 17 IADL outcomes, scored on a range from 0 (patient does not perform the activity), to the highest score (patient is independent in the activity). The scale is administered with caregivers who are asked to rate the degree to which their care-recipient performs each item in the last four weeks. The ADCS-ADL has been identified to be a reliable and valid instrument, with high internal consistency and sensitivity to functional changes in individuals with mild-to-moderate dementia.
次要结局
- Change from baseline in quality of life of participants(This will be administered at baseline (week 0), and post-intervention (week 8).)
- Change from baseline in the global cognitive functioning of participants(This will be administered at baseline (week 0), and post-intervention (week 8).)
- Change from baseline in cognition of participants(This will be administered at baseline (week 0), and post-intervention (week 8).)
- Change from baseline in communication ability of participants(This will be administered at baseline (week 0), and post-intervention (week 8).)
- Change from baseline in neuropsychiatric symptoms of participants(This will be administered at baseline (week 0), and post-intervention (week 8).)
研究者
Simone Ryan
Principal Investigator; Occupational Therapist
National University of Ireland, Galway, Ireland