Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE 2024)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Recruitment rate of participants
研究概览
简要总结
Background and study aims Dementia affects about 800,000 people in the UK, with the number expected to rise. As well as searching for medical treatments for dementia, there is a need for helpful social activities to support people with dementia to live well with the condition. People with dementia are at risk of social isolation and mental health problems, and family carers can feel unsupported and over-burdened by their role. Studies have suggested that group singing can improve mood, memory and relationships for people with dementia, and establish support networks which help carers. The shared activity of singing together may have benefits for the relationship between person with dementia and carer too. However, to date no large scale studies about community singing and dementia have been conducted. This study is a feasibility study, meaning that it aims to try out a study design to see if it would work on a larger scale. In particular, we want to see if we can recruit enough people to take part in the study, and whether they will remain in the study for long enough to collect all the data we need.
Who can participate? Patients who have received a diagnosis of dementia, who are willing to join a singing group, and who have a carer who is willing to join the study with them.
What does the study involve? Participants will be randomly assigned to either attend group singing straight away, or to wait for 10 weeks before attending group singing. We will collect data about their quality of life, mood, and cognitive function at several time points, so we can compare the differences between people who attend singing straight away and those who wait. The data we collect from this feasibility study will allow us to plan a larger trial of singing for people with dementia.
What are the possible benefits and risks of participating? Participants in the study will have the opportunity to attend singing groups. Many attendees at these groups report finding them stimulating and enjoyable. However, not everyone will necessarily enjoy the singing groups even if others do (for example, if they do not like the songs chosen for a certain week). Participants will also be asked to complete questionnaires and tests three times during the study. Every effort will be made to ensure this experience is not too tiring or difficult, but some participants may find it burdensome.
详细描述
PURPOSE The purpose of PRESIDE is to test the feasibility of conducting a randomised trial of community singing in dementia that investigates the effects of singing on quality of life and explores the impact singing groups have on the relationship between the person with dementia (PwD) and carer.
PRIMARY OBJECTIVE The primary objective of the PRESIDE study is to test the protocol for a two-arm, parallel group superiority randomised trial of community singing in dementia with a waiting-list control design. The relevant indicators are recruitment, retention, and the acceptability of the trial design.
SECONDARY OBJECTIVES The secondary objective of the study is to explore the impact of group singing on PwD and their carers. This would improve understanding of the mechanisms of action in group singing for PwD and potentially indicate suitable outcome measures for full-scale trial.
DATA COLLECTION A mixed-method design will be applied to collect data using questionnaires, semi-structured interviews and observations.
PRIMARY END POINT The attainment of the feasibility criteria at 6 months is the primary end point for PRESIDE. Proposed criteria for proceeding to a full trial: 70% recruitment; 70% retention of participants over 3 months; and acceptability of waiting-list controls shown by 70% singing group take-up post waiting-list period.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
In pragmatic terms, masking or trial 'blinding' is not possible nor desirable for this study; instead we will aim to keep assessors and trial statistician in ignorance of participants' allocations, and to monitor success by asking assessors to judge those allocations & their confidence therein.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant with dementia:
- •To be diagnosed with dementia which is at a mild or moderate level
- •Aged ≥18 years
- •To have a carer who spends at least 2 h per week with them and who is willing to attend the group
- •Willing to join a singing group and attend weekly
- •Able to give informed consent
- •Able to speak and understand English.
- •Able to speak and understand English.
- •Willing in principle to attend the group regularly
- •Able to give informed consent
排除标准
- •Participants with dementia:
- •Lacking capacity to give informed consent
- •Has engaged regularly in a singing group (other than religious services) in the past 6 weeks
- •Significant hearing impairment
- •Simultaneous participation in any other interventional study.
- •History of severe mental illness, or alcohol/drug addiction
- •Lacking capacity to give informed consent
- •Significant hearing impairment
- •Simultaneous participation in any other interventional study.
- •History of severe mental illness, or alcohol/drug addiction
结局指标
主要结局
Recruitment rate of participants
时间窗: 2 years
Recruitment rate is the number of participants recruited throughout the study compared to the set number of participants required to reach statistical power. To assess the feasibility of gaining recruitment into community singing groups with the potential of having a waiting-list control group is investigated. Recruitment of all participants into the study against target figures will be reported as a recruitment rate (as a percentage or ratio) and form an independent unit of measure to provide an indication whether or not recruitment targets are likely to be achieved should a randomised control trial be pursued.
Retention rate of participants
时间窗: 2 years
Retention rate is calculated by measuring the number of participants who were recruited into the study against the number of participants that completed the duration of the study (either by percentage or ratio). Retention rate of all participants as a unit of measure throughout the two-year period will be analysed. Waiting list control group participant retention data will be compared against intervention group participant retention data which will provide an understanding as to whether participants would be willing to wait to participate in the group singing activities. This provides a unit of measure to calculate the feasibility of the waiting list control study design. Participant retention rates (using the unit of measure outlined above) will be analysed throughout the two-year period to further investigate if and when participants may be at risk of study withdrawal (reported as either a percentage or a ratio).
次要结局
- Three-item Loneliness Scale(6 months)
- DEMQOL/DEMQOL-Proxy(6 months)
- Music Engagement Questionnaire(1 month)
- Short Warwick-Edinburgh Mental Wellbeing Scale(6 months)
- Engagement and Independence in Dementia Questionnaire(6 months)
- EuroQoL-5D-5L(6 months)
- Mini Mental State Examination(6 months)
- Scales measuring the impact of Dementia on Carers(6 months)
- The Geriatric Depression Scale(6 months)
- The Client Service Receipt Inventory(6 months)