跳至主要内容
临床试验/NCT07347639
NCT07347639已完成不适用

SOCAV: a Nurse-led Support Programme for Self-direction in People With Dementia in Dutch Home Care, Involving Informal Caregivers - a Feasibility Study With Process Evaluation

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2020年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Canadian Occupational Performance Measure

研究概览

简要总结

In this study, we tested whether a support program could help people living at home with dementia keep making their own everyday choices for as long as possible, with help from a family caregiver and a home-care nurse. Nurses received training and coaching to better focus on what the person still wants and can do, and to avoid taking over tasks too quickly. The program also included home conversations with the person with dementia and their caregiver to agree on what matters most and how to support that in daily life. In total, 12 people with dementia, 14 caregivers, and 33 nurses took part. Most participants felt the program was helpful and said it increased attention to personal choice and small day-to-day decisions. However, it also took time and was sometimes hard to schedule, and some people dropped out. The questionnaires did not show clear improvements in things like quality of life, but there were signs that some behavior problems (such as restlessness or difficult situations) became less frequent for some participants.

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

盲法说明

Not applicable. This was a single-arm feasibility study and no additional parties were formally masked/blinded; participants (people with dementia and informal caregivers), nurses, peer coaches, and the research team were aware of the intervention. Interviewers were independent/unknown to participants, but they were not blinded to intervention exposure.

入排标准

性别
All
接受健康志愿者

入选标准

  • People with dementia were eligible if they had mild to moderate dementia (diagnosed by a general practitioner or geriatrician), lived at home, and received care from a home-care team.
  • Informal caregivers were eligible if they provided care at least twice per week, either as a co-residing primary caregiver or as a regularly visiting secondary caregiver.
  • Nurses were eligible if they worked in home care, supported people with dementia, and were employed by the regional care organization.

排除标准

  • People with dementia were excluded if they had a Geriatric Depression Scale (GDS) score >6;

结局指标

主要结局

Canadian Occupational Performance Measure

时间窗: The COPM was administered at baseline and 5 months in the development phase, and in the feasibility phase at baseline, 4 months (midpoint), and 9 months (endpoint).

The Canadian Occupational Performance Measure (COPM) (Dutch version) is a tool to assess change in performance of meaningful daily activities and satisfaction with that performance, each rated on a 1-10 scale (1 = not able/not satisfied at all; 10 = fully able/fully satisfied), based on input from the person with dementia, the informal caregiver, and the home-care nurse. Main Manuscript

次要结局

  • The Dementia Quality of Life (DQoL)(The DQoL was collected as a primary outcome at baseline, 4 months (midpoint), and 9 months (endpoint) in the feasibility phase (and at baseline and 5 months in the development phase).)
  • Centre for Epidemiologic Studies Depression Scale (CES-D),(In the feasibility phase, the CES-D was assessed at baseline, 4 months, and 9 months (and at baseline and 5 months in the development phase).)

研究者

发起方
Radboud University Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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