Once 'Stepping On' Ends: Continuing a Group Falls Prevention Program Via the Internet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Change of Number of Falls From Baseline to 6 Months
研究概览
简要总结
The overall purpose of this multi-phase study is to develop (Phase 1) and test potential effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls prevention maintenance program for Stepping On (SO) graduates in a group randomized trial (Phase 2).
This application refers to effectiveness component of Phase 2, which entails the randomized clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail process evaluation of the Stepping Online intervention group only.
详细描述
Aim:
This application, for Phase 2 of a larger study, is a 6-month group randomized trial to test the effectiveness of Stepping Online.
Stepping Online (developed in Phase 1) is a continuation website to help Stepping On graduates to:
- Maintain exercises and fall prevention strategies learned in Stepping On, and
- Stay connected with other participants and leaders/peer leaders in the 7-week workshop.
Approach:
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •List of Inclusion Criteria:
- •Leader/Peer Leader: Leading a SO workshop in Dane, Milwaukee, Rock, Adams, Green Lake, Marquette or Waushara counties during the timeframe prior to the 6-month trial.
- •Stepping On Participants/Graduates: Enrolled in one of the above SO workshops.
- •In Milwaukee and Dane counties, extra effort will be made to enroll African American Stepping On participants/graduates, who are more likely to have lower income and educational level and to be uninsured than their White counterparts.
排除标准
- •Leaders/Peer Leaders:
- •Not available to participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
- •Not in the area at the end of the 6-month trial.
- •Stepping On Participants/Graduates:
- •Unable participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
- •Not assessed to be safe by SO leader to do the online exercise program; not in the area for the 3 month and 6 month evaluations
研究组 & 干预措施
Stepping Online
Stepping On graduates receive Stepping Online, a password-protected continuation website to maintain fall prevention behaviors.
- Fall prevention tips
- Fall prevention exercise videos noting technique and safety
- Guest expert videos and communication with expert
- Tools to set exercise goals, reminders and track progress
- Fall prevention specialist for feedback and group activities
- Discussion and messaging (1:1, small and large group)
- Fall prevention resources.
干预措施: Stepping Online (Behavioral)
Stepping On Usual Care Control
Subjects control workshops in the condition will not have access to Stepping Online.
结局指标
主要结局
Change of Number of Falls From Baseline to 6 Months
时间窗: baseline and 6 months
Number of Falls: monthly calendar self-administered sent and returned via mail
次要结局
- Short Physical Performance Battery (SPPB): Total Balance Test(up to 6 months)
- Short Physical Performance Battery (SPPB): Chair Stand Test(up to 6 months)
- T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument(up to 6 months)
- Physical Activity Barriers Self-Efficacy Score(up to 6 months)
- Global Rating of Change Score at 6 Months(6 months)
- Short Physical Performance Battery (SPPB): Gait Speed Test(6 months)
- T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument(up to 6 months)
- Number of Tandem Walk Errors at 3 Months and 6 Months(up to 6 months)
- Falls Behavioral Risk Scale (FaB)(up to 6 months)
- Strength Exercise Adherence at 3 and 6 Months(up to 6 months)
- Gait Speed at 3 Months and 6 Months(up to 6 months)
- Short Physical Performance Battery (SPPB): Summary Score(up to 6 months)
- Social Bonding Score at 3 Months and 6 Months(up to 6 months)
- Encouragement to do Exercises Score at 3 Months and 6 Months(up to 6 months)
- Activities Balance Confidence (ABC) Scale at 3 and 6 Months(up to 6 months)
- Revised UCLA Loneliness Scale (R-UCLA)(up to 6 months)
- Balance Exercise Adherence at 3 and 6 Months(up to 6 months)