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临床试验/NCT02946593
NCT02946593已完成不适用

Stroll Safe Outdoor Fall Prevention Program

New York University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Change in Outdoor Falls Questionnaire (OFQ)

研究概览

简要总结

The purpose of the study is to examine the feasibility of the program and data collection protocol to plan a multisite clinical trial. The program, "Stroll Safe", an outdoor fall prevention program, will take place in the lab space of the New York University occupational therapy department and in the surrounding neighborhood.

Twenty-four people who meet the inclusion criteria will be enrolled after informed consent. Recruitment will include follow up with people who expressed interest in the fall prevention program during a survey study conducted by the PI, and interested members of community-based programs for seniors who have agreed to be community partners for this study. Twelve participants will be assigned to the 7-week program and 12 will receive written information on outdoor fall prevention (control group).

The topics addressed in the once a week, 7-week outdoor falls prevention program, for which a treatment manual has been developed, are based on the results of a survey conducted of community dwelling older adults that identified gaps in knowledge and use of prevention strategies, and the related literature. The program includes pre-set modules, however, participants will be able to voice individual concerns and problem-solve solutions during group discussions. Using an ecological perspective, the Health Belief Model, and problem solving theory as a guide, the intervention will include a didactic component, group problem solving, practical application of strategies, and self-advocacy regarding reporting problems to the city.

Analysis will primarily focus on process measures.Post-intervention, semi-structures interviews will be conducted and analyzed to assess strengths/limitations of the program and participant's attribution of any behavioral changes to the intervention. Although statistical significant is not anticipated in this small feasibility study, repeated measures ANOVA will be used to examine changes in Falls Efficacy Scale-International (FES-I), Outdoor Falls Questionnaire (OFQ) and Falls Behavioral Scale for the Older Person (FaB) scores from pre to post-test for the treatment and control groups. Effect sizes (Cohen's d) will also be calculated. Change in number of stumbles, trips, slips, and falls before and after the program will also be analyzed.

Data will be collected on falls self-efficacy and strategy use at study enrollment (Baseline), after completion of the 7 week program (1st Post-test), and at 2 months post-program completion (2nd Post-test). Participants will be asked to keep daily diaries of stumbles, trips, slips, and falls from the time they enroll in the study until two months following the completion of the program.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 55 years of age or older
  • English speaking
  • Cognitively competent (i.e. a Montreal Cognitive Impairment (MOCA) score >24)
  • Able to ambulate outdoors independently with or without an assistive device
  • Able to travel independently to the program site
  • Have sustained a stumble, trip, slip or fall outdoors within the last year

排除标准

  • Younger than age 55
  • Living in an institutional setting
  • Non-English speaker
  • Requiring assistance for outdoor ambulation and/or community mobility
  • Cognitively impaired as per MOCA scores
  • An active medical, neurological or psychiatric disease that interferes with participation (e.g. stroke, chronic obstructive pulmonary disease requiring supplemental oxygen, Amyotrophic Lateral Sclerosis, and schizophrenia).

结局指标

主要结局

Change in Outdoor Falls Questionnaire (OFQ)

时间窗: Baseline, following 7-week program, 2 months post program completion

Change in Falls Behavioral Scale for the Older Person (FaB)

时间窗: Baseline, following 7-week program, 2 months post program completion

Change in Falls Self-efficacy Scale- International (FES-I)

时间窗: Baseline, following 7-week program, 2 months post program completion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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