Study Protocol of the D-SCOPE Project With a Randomized Controlled Trial, Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 869
- 试验地点
- 3
- 主要终点
- Change from baseline Quality of Life at 6 months
研究概览
简要总结
The evaluation of a detection and prevention program which aims to create a continuum of care and support for frail community-dwelling older people (from early detection, over intervention, to follow-up). First, the program aims to develop methods to easily, accurately and timely detect and prevent a negative frailty-balance in older people. Second, the study aims to improve the quality and efficacy of care and support given to frail community-dwelling older people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sample 1: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: at least one selection criterion)
- •Gender: 75 men - 75 women
- •Age: 25 older people aged between 60 and 70 years old - 125 older people older than 70 years
- •Marital status: 50 older people with partner - 100 older people without partner
- •Living situation: 100 older people who have not moved last 10 years - 50 older people who have moved last 10 years
- •Migration background: 100 older people born in Belgium - 50 older people born elsewhere
- •Sample 2: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: all selection criteria at once)
- •75 men, older than 70 years, living together/widowed/divorced/never married, moved last 10 years
- •75 women, older than 70 years, widowed/divorced/never married, moved last 10 years
排除标准
- •Current institutionalization
- •Current hospitalization
研究组 & 干预措施
Risk of being frail experimental group
干预措施: Tailored care and support (Behavioral)
Risk of being frail control group
No/low risk of being frail
Risk of being frail care avoiders
结局指标
主要结局
Change from baseline Quality of Life at 6 months
时间窗: Assessed during baseline testing + 6 months after inclusion
One question from the WHOQOL-BREF will be used to measure the quality of life of participants (1 item). Older participants will also be asked to rate their quality of life on a scale from 0 to 10.
Change from baseline aging well in place at 6 months
时间窗: Assessed during baseline testing + 6 months after inclusion
One self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner
Change from baseline Community Inclusion at 6 months
时间窗: Assessed during baseline testing + 6 months after inclusion
Community inclusion will be measured using 1 item from the Community Integration Measure (CIM). Older participants will also be asked to rate their community inclusion on a scale from 0 to 10.
Change from baseline Satisfaction with Life at 6 months
时间窗: Assessed during baseline testing + 6 months after inclusion
The Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)
Change from baseline sense of mastery at 6 months
时间窗: Assessed during baseline testing + 6 months after inclusion
To assess the sense of mastery of older people, the current mastery questionnaire will be used and one self-constructed item will be added which will assess mastery in relation to others. Older participants will also be asked to rate their mastery on a scale from 0 to 10.
Change from baseline Meaning in Life at 6 months
时间窗: Assessed during baseline testing + 6 months after inclusion
Meaning in life will be evaluated with 5 items from the Meaning in Life Questionnaire (MLQ). Older participants will also be asked to rate their meaning in life on a scale from 0 to 10.
次要结局
- Multidimensional frailty(Assessed during baseline testing + 6 months after inclusion)
- Resilience(Assessed during baseline testing + 6 months after inclusion)
- Coping(Assessed during baseline testing + 6 months after inclusion)
- Physical phenotype of frailty(Assessed during baseline testing + 6 months after inclusion)
- Feeling frail(Assessed during baseline testing + 6 months after inclusion)
- Help needed for activities in daily life(Assessed during baseline testing + 6 months after inclusion)
- Medical care(Assessed during baseline testing + 6 months after inclusion)
- Leisure time(Assessed during baseline testing + 6 months after inclusion)
- Neighborhood(Assessed during baseline testing + 6 months after inclusion)
- Life-events(Assessed during baseline testing + 6 months after inclusion)
- Informal and formal care(Assessed during baseline testing + 6 months after inclusion)
研究者
Liesbeth De Donder
Prof. Dr. Liesbeth De Donder
Vrije Universiteit Brussel