Family FINGER: a Pilot Randomised Controlled Trial of Healthy Lifestyle Intervention Versus Standard Care Among Older Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The Family FINGER study enrolls caregivers aged 65 or older who live with and care for a spouse with cognitive impairment in North Savo, Finland (estimated n=100). This intervention builds on the FINGER study, which showed improved cognitive performance and health benefits, including better health-related quality of life. The intervention will be tailored to meet caregivers' specific needs.
The overall aim of the Family FINGER trial is to assess the efficacy of this intervention on the positive mental health of spousal caregivers.
Specific research questions are as follows:
- What is the efficacy of the Family FINGER intervention on mental health?
- What is the efficacy of the Family FINGER intervention on secondary outcome measures: dementia risk, cognition, and lifestyles?
详细描述
Background:
This study applies the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) intervention model among family caregivers.
Study design:
Randomised, controlled, parallel-group, single-centre pilot trial testing the efficacy of the multidomain Family FINGER lifestyle intervention on positive mental health versus standard care.
Recruitment:
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 (Participant, Outcomes Assessor)
盲法说明
Participants will not be actively told to what group they have been assigned (intervention or control). Primary outcome assessors will be blinded to the group allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 65 and older.
- •Caregiver for a spouse with cognitive impairment.
- •Live in the same household with the care recipient.
- •The presence of modifiable risk factors for health: at least one self-reported lifestyle-related risk factor, or self-reported CAIDE dementia risk scores of 6 or higher, or a self-reported burdensome caregiving situation.
排除标准
- •A medication for Alzheimer's disease or diagnosis of dementia or suspected dementia (such as referral to or ongoing assessment process at memory clinic, or MoCa < 18 points).
- •Any health condition affecting safe engagement in the intervention, or the caregiving situation is such that specialised social or health care services are needed before safe engagement in the intervention can be ensured, according to clinical judgement.
研究组 & 干预措施
Healthy Lifestyle Intervention
干预措施: a multidomain lifestyle intervention (Behavioral)
Standard Care
研究者
Tarja Välimäki
Professor
University of Eastern Finland