BE-EMPOWERed Study: Belgian Study Enhancing the Uptake and the Effectiveness of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Fidelity of the group program
研究概览
简要总结
Approximately 24 to 40% community-dwelling older persons fall annually, of which 21 to 45% fall recurrently. Many factors contribute to the risk of falling, such as mobility impairment, medication use, environmental issues and risk behavior. Falls are associated with an increased risk of morbidity and mortality and often lead to physical and psychosocial consequences. Falls and related injuries have a huge economic impact on society. Given its proven efficacy as shown by controlled trials, multifactorial falls prevention interventions are recommended as primary strategy. However, poor implementation in daily clinical practice leads to inconclusive results on clinical outcomes. Several studies show that implementation, effectiveness and context are linked. Context is a critical concept to understand variation in implementation and clinical outcomes. Therefore, it is necessary to comprehensively understand the context prior to implementation.To date, the context and tailored implementation are neglected in the majority of falls prevention research. Given this, this Belgian study aims to Enhance the uptake and the Effectiveness of a Multifactorial falls Prevention intervention in Older community-dWElling peRsons (BE-EMPOWERed).
详细描述
The overall objective is to comprehensively evaluate the BE-EMPOWERed program on clinical and implementation outcomes and assess the implementation processes.The BE-EMPOWERed program consists of a multifactorial falls prevention intervention in older persons and strategies to implement the intervention, both tailored to the community setting in Belgium (Flanders).
Aim: To implement the BE-EMPOWERed program in 4 primary care areas in Belgium (Flanders) and to explore the effectiveness on clinical outcomes and to assess the implementation process and outcomes in a mixed methods study with a convergent parallel design.
i. To explore the effectiveness of the BE-EMPOWERed program on fear of falling.
ii. To assess the implementation outcomes for the BE-EMPOWERed program such as: reach, fidelity, feasibility, acceptability, sustainability and implementation costs.
iii. To understand the implementation process of the BE-EMPOWERed program from the perspective of the older persons, healthcare professionals, local service centers and local policy makers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •group program:
- •Community-dwelling
- •65 years and over
- •Independent with or without walking aid
- •Understanding and speaking of the Dutch language
- •Experienced one or more of the following events in the past year? (1) one or more falls; or (2) mobility or balance problems; or (3) concerns about falling
排除标准
- •group program:
- •- Neurological and cognitive problems (Parkinson, CVA, dementia, delirium)
- •Inclusion Criteria workshops:
- •Healthcare professionals
- •Working in the primary care area
- •Understanding and speaking of the Dutch language
研究组 & 干预措施
BE-EMPOWERed program
The BE-EMPOWERed program entails a group program for older people, workshops for healthcare professionals and a 6-steps implementation plan for primary care areas. The group program for older people is based on the main principles of the Australian multifactorial falls prevention program 'Stepping On'. The workshops for healthcare professionals focus on the multifactorial falls prevention approach, reimbursement of healthcare costs, referrals to other healthcare professionals and motivational interviewing. The Implementation plan consists of 6-steps: 1. enable support, 2. map baseline situation, 3. define objectives and priorities, 4. plan implementation, 5. implementation and 6. evaluation, adjust and work towards sustainability. Last, to support the primary care areas, implementation facilitators were trained.
干预措施: BE-EMPOWERed program (Other)
结局指标
主要结局
Fidelity of the group program
时间窗: Immediately after every session and follow-up session (up to 8 months).
Fidelity is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. Based on the key elements of the group program a questionnaire was developed (fidelity checklist). After every group program the group leader will fill in this questionnaire. The researcher will also observe one out of seven sessions and give feedback to the group leader based on the key elements of this questionnaire (fidelity checklist). The percentage of key elements that were complied or not complied to by the group leader will be measured.
Fidelity of the workshops
时间窗: Immediately after every workshop (up to 1 month).
Fidelity is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. Fidelity checklist by the trainer. Based on the key elements of the workshops a questionnaire was developed (fidelity checklist). After every workshop the trainer will fill in this questionnaire (self reporting) The percentage of key elements that were complied or not complied to by the trainer will be measured.
次要结局
- Implementation cost(2 years)
- Reach older people(Immediately after every session and follow-up session (up to 8 months).)
- Falls Behaviour of the older person(Baseline and after 6 months)
- Concerns about falling(Baseline and after 6 months)
- Reach of healthcare professionals(Immediately after every workshop (up to 1 month).)
- Experiences with the BE-EMPOWERed program(The last 6 months of the study.)
- Feasibility of the BE-EMPOWERed program by experiences of the participants(The last 6 months of the study.)
- Acceptability of the BE-EMPOWERed program by experiences of the participants(The last 6 months of the study.)
- Physical activity(Baseline and after 6 months)