Remote Online Administration of Otago Exercise Program for Individuals With Dementia and Their Care Partners: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change over time (immediate post-intervention, delayed post-intervention) in Adherence / Participation
研究概览
简要总结
Individuals with dementia (IwDs) fall more and are more seriously injured in falls than their age-matched, cognitively intact peers. An accessible and sustainable fall prevention program would be of great value. Using remote technology has become commonplace during the COVID-19 pandemic, and Marymount University's new Center for Optimal Aging plans to use this technology to bring a web-based version of a well-established and accepted evidence-based fall prevention intervention, the Otago Exercise Program, into the homes of IwDs and their care partners. Care partners will be trained in the home for safety and oversight of their exercising partner with dementia. Dyads of IwD and care partners will access the online exercise program through an online Learning Management System (Canvas) three times per week which tracks their access to exercise videos. Once per week, exercise will take place in a Zoom format with a small cohort of other dyads, supervised by a research team member, and the other two times will be independent access of exercise videos. The purpose of this study is to determine the viability of remote administration of the Otago Exercise Program by assessing program functionality, utility, and effectiveness. Feasibility will be evaluated by using components of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). The results will guide and inform adaptations of future remote training efforts for IwD, with implications at the individual, family, and societal levels.
详细描述
Methodology Overview:
This 16-week prospective study will examine feasibility of remotely administered Otago Exercise Program (OEP) for Individuals with Dementia (IwD) supervised by their care partners (n=24 dyads) using select components of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). Specifically, data on program adherence, system usability, enjoyment, and adverse events will inform the ability of Marymount Center for Optimal Aging to work with partners to Adopt and Implement this programming for the older adult community. Additionally, this within-subject design study will assess measures of balance, mobility, falls, cognition, & confidence to assess preliminary data on Effectiveness, should the program be feasible. Finally, Reach will be evaluated by comparing demographic data of participants recruited as compared to the target local community, which is broadly diverse in terms of age, race, ethnicity, economic status, health status, culture, and language.
Existing studies demonstrate that home based exercise for IwD with care partners are feasible and safe, providing there is careful orientation to safety measures and continued support and follow up over the course of the study. Inclusion/exclusion criteria are designed to avoid inclusion of very high risk fallers (i.e., use of assistive device).
All assessments will be performed in the participant's home with oversight by a licensed physical therapist (PT) with geriatric expertise. A PT/PT student team will be assigned to each dyad for the duration of the study and the team will have regular contact with the dyad to direct activities, discuss questions and concerns, and provide support over the initial 8-weeks of the study, and waning contact over the final 8-weeks of the study. Students will be vetted and trained by the PTs. A detailed procedures manual describing all testing, remote exercise administration, and data collection procedures will be followed by all research team members.
After an enrollment visit and consent, pre-test assessment, and education/safety training for home exercise (Week 0), IwD with care-partner supervision will participate in remote OEP (3x/week x 8 weeks) with 1x/week synchronous/real time with an online research team instructor and small group (<3) of other dyads. The other sessions (2x/wk) will be carried out independently by dyads using pre-recorded videos of exercises without live instruction. Following completion of the 8-wk OEP, immediate post-testing (Week 8) will occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change over time (immediate post-intervention, delayed post-intervention) in Adherence / Participation
时间窗: Assessed at Weeks 8 and 16
Measured by attendance \& participation at synchronous sessions and by number of "views" recorded through Canvas website for asynchronous sessions.
Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in 4-Stage Balance Test (4-SBT)
时间窗: Assessed at Weeks 0, 8, and 16
The participant will stand with feet in four different positions and be timed for up to 10 seconds in each position. The positions are: (1) feet side by side, (2) staggered stance with feet next to each other, (3) one foot in front of the other, and (4) standing on one foot.
Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in 30-second Sit to Stand (30s STS)
时间窗: Assessed at Weeks 0, 8, and 16
The number of stands completed in 30 seconds without use of arms from a standard kitchen or dining room chair (standard test is with 17-inch seat to floor height).
Change over time (immediate post-intervention, delayed post-intervention) in System Usability Scale (SUS)
时间窗: Assessed at Weeks 8 and 16
SUS is a 10-item Likert survey and scores are between 0-100 with higher scores representing better usability.
次要结局
- Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in Timed Up and Go (TUG)(Assessed at Weeks 0, 8, and 16)
- Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in Burden Scale for Family Caregivers-Short Version (BSFC).(Assessed at Weeks 0, 8 and 16)
- Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in Short Falls Efficacy Scale-International (Short FES-I)(Assessed at Weeks 0, 8, and 16)
- Change over time (pre-intervention and delayed post-intervention) in Montreal Cognitive Assessment (MoCA).(Assessed at Weeks 0 and 16)
研究者
Julie Ries
Professor of Physical Therapy, Research Fellow of Center for Optimal Aging
Marymount University