Feasibility, Acceptability and Adherence of the Fall Prevention Pathways With Remote Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adherence to program
研究概览
简要总结
Falls are a leading cause of injury and loss of independence in older adults, with evidence supporting exercise-based interventions and remote monitoring as effective strategies for reducing fall risk. However, adherence and engagement with such programs remain significant challenges.
This study builds on prior research demonstrating the feasibility of digital health interventions in rehabilitation and extends it to a structured, remotely monitored Fall Prevention Pathway (FPP). Preliminary work in digital rehabilitation has shown positive engagement and clinical outcomes, supporting the need for further exploration of feasibility, adherence, and cost implications of remotely monitored fall prevention programs.
详细描述
This study will evaluate the Fall Prevention Pathways (FPP) program, a digital rehabilitation intervention that assesses the impact of remote monitoring in reducing fall risk in community-dwelling older adults.
Participants will be enrolled in an 8-week intervention and followed for an additional 6 months. The study will assess feasibility, patient adherence, engagement, clinical outcomes, and cost implications. Data collection will occur at baseline (0 weeks), post-intervention (8 weeks), and follow-ups at 13 weeks (3 months) and 26 weeks (6 months).
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 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 65-85 years
- •Community-dwelling individuals classified as low to moderate fall risk based on standardized assessments, (i.e., the Stay Independent Screener)
- •Ability to ambulate independently or with a single-point cane
- •Willingness to participate in an 8-week intervention with remote monitoring
- •Access to a smartphone, tablet, or computer with internet connectivity
- •Ability to provide informed consent
排除标准
- •Severe cognitive impairment or a diagnosis of dementia that would affect adherence or ability to provide consent
- •Neurological or vestibular disorders (e.g., Parkinson's disease, multiple sclerosis, history of stroke with residual balance impairment)
- •Severe comorbidities that significantly impact mobility and function (e.g., recent orthopedic surgery, unstable cardiac conditions)
- •Significant visual or hearing impairments that prevent engagement with digital health interventions
- •Non-ambulatory or requiring assistance of another person for mobility
研究组 & 干预措施
The Fall Prevention Pathway (FPP)
Participants will be enrolled in an 8-week FPP intervention program. After completion of the 8-week FPP intervention, participants will undergo long-term follow-up assessments at 13 weeks (3 months) and 26 weeks (6 months) post-intervention. The follow-up assessments aim to assess sustained engagement, adherence, clinical outcomes, and fall incidence.
干预措施: The Fall Prevention Pathway (FPP) (Behavioral)
结局指标
主要结局
Adherence to program
时间窗: At the end of the intervention (8 weeks)
Adherence will be measured as the number of participants who complete ≥3 days of activity per week
Number of participants who complete the intervention
时间窗: 3 months and 6 months post-intervention
Number of participants (Retention rate) who remain in the study
次要结局
- 30-Second Sit-to-Stand test(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Gait speed over 20 feet(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Tandem stance (from 4 stage balance test),(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Short Form 12-Quality of Life (SF12)(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Falls Efficacy Scale (FES-I)(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Activities-specific Balance Confidence Scale (ABC)(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Physical Activity Scale for the Elderly (PASE)(Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention))
- Net Promoter Score (NPS)(8 weeks (end of the intervention))
研究者
Madeleine Eve Hackney
Assistant Professor of Medicine
Emory University