跳至主要内容
临床试验/NCT07011498
NCT07011498进行中(未招募)不适用

Connecting Through Choir Singing: Dementia Choirs to Reduce Loneliness in Home-dwelling Persons Living With Dementia and Their Caregivers - a Crossover Study

Norwegian Academy of Music1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Change from baseline in degree of loneliness in participants with dementia at 12 weeks (primary), 22 weeks and 36 weeks follow up

研究概览

简要总结

Loneliness is common in both persons living with dementia and their informal caregivers, and a factor negatively affecting disease progression, health and wellbeing. However, intervention studies to address loneliness show inconsistent effects. This study aims to evaluate effect of a community-based group intervention - music therapy informed dementia choirs - on loneliness for home-dwelling people with dementia and their informal caregivers. We will recruit participants to five dementia choirs with 15-20 people in each and implement a crossover study with measures collected at four timepoints: baseline, 12-week follow up, 22-week follow-up after an extended summer holiday, and 12-week follow-up after the summer holiday. The primary outcome, loneliness in participants living with dementia, will be measured using the De Jong Gierveld loneliness scale. Secondary outcomes will be depression, experience of meaning in life, apathy and mood for the participants living with dementia, and loneliness and caregiver burden for the informal caregivers. Cognition in the participants living with dementia, measured with the RUDAS assessment tool, will be included as a control variable. Further, measurements to evaluate the cost effectiveness of the choir intervention will be included, and qualitative data collected through semi-structured interviews to explore the experiences and possible impacts of the choir intervention in the participants' lives.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dementia diagnosis (Alzheimers, Lewy-body, fronto-temporal, vascular, mixed, Parkinson's dementia) or cognitive impairment as reported by the person themselves/their caregiver
  • Informal caregiver of participant with dementia: A person who has a close relationship with a recruited choir participant living with dementia. A close relationship may for instance be a spouse/partner, sibling, adult child, friend, niece or nephew
  • Living at home in the community

排除标准

  • Significant hearing impairment that is not resolved through the use of a hearing aid device and limit their capacity to enjoy musical experiences.
  • Formal (paid) caregiver of participant with dementia

研究组 & 干预措施

Dementia choir

Experimental

干预措施: Dementia choir (Other)

结局指标

主要结局

Change from baseline in degree of loneliness in participants with dementia at 12 weeks (primary), 22 weeks and 36 weeks follow up

时间窗: From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.

Measured by the standardised questionnaire the De Jong Gierveld 6-item Loneliness Scale

次要结局

  • Change of mood in participant with dementia from before to after choir rehearsals(From before to after rehearsals for rehearsals 2, 6 and 11 (per choir).)
  • Change from baseline in degree of depression in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up(From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.)
  • Change from baseline in degree of self-reported meaning in life in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up(From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.)
  • Change from baseline in degree of caregiver burden to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.(From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.)
  • Change from baseline in degree of apathy in participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up(From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.)
  • Change from baseline in degree of loneliness in informal caregivers of participants with dementia to 12-week (primary timepoint), 22-week and 26-week follow up(From baseline to 12-week follow up (primary timepoint), 22-week follow up and 36-week follow up.)

研究者

发起方
Norwegian Academy of Music
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验