跳至主要内容
临床试验/NCT05192408
NCT05192408进行中(未招募)不适用

Multi-component Intervention for Reducing Fear of Falling in Community-dwelling Older Adults

National Healthcare Group Polyclinics1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2022年1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)
入组人数
420
试验地点
1
主要终点
Fear of Falling (FoF)

研究概览

简要总结

In the short term, the study will provide insight into the effectiveness of multi-component intervention for reducing Fear of falling (FoF) in community-dwelling older adults. Effective interventions will be incorporated into existing programs for frailty and falls prevention in primary care. Reducing FoF will break the cycle of physical activity restriction, functional decline and further falls in older adults. Long term potential benefits include improving the health status of older adults and thus reducing healthcare utilization.

The primary aim is to compare the effectiveness of a multi-component intervention comprising exercise recommendations, cognitive behavioural therapy (CBT) components and motivational interviewing (MI) based telephone review against usual care for reducing Fear of Falling (FoF) in community- dwelling older adults.

Secondary aims include to compare the effectiveness of the multi-component intervention against usual care for increasing physical activity and reducing falls in community- dwelling older adults.

The hypothesis is that the multi-component intervention will be more effective as compared to usual care for reducing FoF and falls and increasing physical activity in community- dwelling older adults.

详细描述

In the short term, the study will provide insight into the effectiveness of multi-component intervention for reducing Fear of falling (FoF) in community-dwelling older adults. Effective interventions will be incorporated into existing programs for frailty and falls prevention in primary care. Reducing FoF will break the cycle of physical activity restriction, functional decline and further falls in older adults. Long term potential benefits include improving the health status of older adults and thus reducing healthcare utilization.

The primary aim is to compare the effectiveness of a multi-component intervention comprising exercise recommendations, cognitive behavioural therapy (CBT) components and motivational interviewing (MI) based telephone review against usual care for reducing Fear of Falling (FoF) in community- dwelling older adults.

Secondary aims include to compare the effectiveness of the multi-component intervention against usual care for increasing physical activity and reducing falls in community- dwelling older adults.

The hypothesis is that the multi-component intervention will be more effective as compared to usual care for reducing FoF and falls and increasing physical activity in community- dwelling older adults.

Sample size was calculated with reference to effect sizes from meta-analyses where effect sizes of 0.28 and 0.33 were found.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Participants and study team members who carry out intervention(nurses) will not be masked. Outcome assessors will be study team members from different clinics as participants or study team members who were not involved in intervention, and will thus be unaware of participants' allocated group.

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Older adults aged 65 and above
  • •Followed up at National Healthcare Group Polyclinics for any chronic condition
  • •Able to communicate in English, Mandarin, Malay
  • •Reports Fear of falling as screened by single question

排除标准

  • •Unable to agree to participation e.g., due to cognitive impairment
  • •Unable or unsafe to participate in any exercise as determined by clinician e.g., terminal illness, uncontrolled hypertension, immobility
  • •Unable to participate in telephone sessions e.g., due to hearing impairment
  • •Known psychiatric condition on treatment

研究组 & 干预措施

Multi-component intervention

Experimental

Individual intervention will comprise:

  1. Cognitive- behavioral therapy (CBT) which includes: - Behavioural activation, cognitive restructuring, promotion of safety, relaxation techniques
  2. Exercise recommendation utilizing current Exercise in older adults Patient Education Materials (PEMs) and videos, tailored based on frailty level and readiness to progress - Components include balance and strength
  3. Use of motivational interviewing (MI) techniques for goal setting

There will be 4 sessions in total. Initial sessions will be carried out face to face or via videoconferencing platform if participant prefers due to ongoing COVID-19 pandemic. Subsequent sessions will be carried out via telephone.

Initial sessions will last around 30 minutes and subsequent sessions will last 15 to 30 minutes.

干预措施: Multi-component intervention (Behavioral)

Usual Care

Other

Patient Education Materials (PEMs) on:

  1. Exercise in older adults (Stay Active, Stay Strong and Stay Steady) - 3 different levels tailored to frailty level and for progression
  2. Falls prevention
  3. FoF

干预措施: Usual Care (Other)

结局指标

主要结局

Fear of Falling (FoF)

时间窗: 3 months

FoF as measured by short FES-I

次要结局

  • Number of falls(3 months)
  • Physical Activity(3 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验