A Pilot Study for the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program (HALT-AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Users' Engagement With the HALT-AD Online Platform by Measuring the Percentage of Participants Who Completed All Courses.
研究概览
简要总结
A Pilot Study for the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia program (HALT-AD). This initial four-months pilot study will focus on at least three educational courses (introduction to dementia and lifestyle risk factors, sleep and diet). It may also include a fourth educational course on social connectivity and loneliness. Completion of this initial pilot study will allow for a round of improvements informed by data from the program, on usability, as well as feedback from participants and citizen advisors. This will allow for an iterative process to build the program to its full content, with feedback to optimize the user experience and ensure the accessibility of the content. The information generated from this study will help inform the development of the second program's prototype, expected to benefit from the initial pilot to become more user-friendly, effective and accessible to the target audience.
This pilot study will be a longitudinal study of an inception cohort exposed to the HALT-AD online educational program for a four-month study. It will utilize pre- and post- intervention collection of quantitative and qualitative data to evaluate the program's first prototype.
详细描述
Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia program (HALT- AD) is a novel bilingual educational program that will focus on reducing risk factors with the ultimate goal of preventing dementia. It will be centered around a web-based interactive virtual online platform that will be developed to be dynamic, engaging, and interactive. Through interactive courses, the educational content of HALT-AD will provide guidance on modifiable lifestyle risk factors and the identification of treatable medical conditions including cerebrovascular health, sleep, sensory loss, social isolation, mood, diet, and physical activity.
Participants in HALT-AD will be provided with personalized risk profiles, will be encouraged to learn about risk factors and how they can effectively modify them, and will be provided with feedback on their progress. Participants will participate in facilitated support discussion groups, which will focus on the content of the educational material and the invocation of change through participant engagement and compliance.
Prior to launching the full HALT-AD program, it is essential that the Sponsor conduct a preliminary pilot study to evaluate the program's first prototype. At the end of the 3-month pilot program, evaluations will include: the usability of- and engagement with- the online platform and users' acceptability of the learning content and facilitated support discussion groups. As well as evaluating preliminary evidence on the effectiveness of the program in changing knowledge, self-efficacy, and dementia-related lifestyle risk factors. The program will also be evaluated on metrics such as being user friendly, engaging, supportive and communicative, with the potential for scalability to state- and national-levels.
Aims:
- To evaluate engagement with- the online platform
- To evaluate preliminary evidence on the effectiveness of the program in changing
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent must be obtained and documented (from the participant).
- •Sufficient proficiency in English or Spanish to undergo clinical assessment and participate in an online educational program.
- •Montreal Cognitive Assessment-Telephone/Blind Version (T-MoCA) score ≥18/22
- •Technical ability to participate in an online educational program (i.e. ability to operate a computer/tablet and gain internet access; ability to send and receive emails)
- •Sufficient vision and hearing to participate in online educational program (judgement of site investigator)
- •Ability to sit comfortably for a period of at least 30 minutes
排除标准
- •Participants who, in the opinion of the co-PIs, are not able to complete trial procedures or adhere to the schedule of study assessments will be excluded from study participation.
- •Individuals where English or Spanish is not sufficiently proficient for clinical assessment, and participation in a web-based educational program.
- •Participants who do not have sufficient vision and hearing to participate in an online educational program
- •Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as ability to operate a computer/tablet and gain internet access; ability to send and receive emails)
- •Total Score on the T-MoCA <18
- •Individuals who have an advanced degree (e.g. Master's, MD, PhD) in an area related to brain health will not be eligible to participate.
结局指标
主要结局
Users' Engagement With the HALT-AD Online Platform by Measuring the Percentage of Participants Who Completed All Courses.
时间窗: 4 months
Users' engagement with the HALT-AD online platform by measuring the percentage of participants who completed all courses.
Users' Engagement With the HALT-AD Online Platform by Measuring the Total Amount of Time (in Minutes) Spent Per User on All Courses Combined
时间窗: 4 months
User engagement with the HALT-AD online platform by measuring the average total amount of time (in minutes) spent per user on all courses combined
次要结局
- Change From Baseline in Knowledge on the HALT-AD Knowledge Assessment Survey at 4 Months(at baseline and 4 months)
- Change From Baseline in Self-efficacy on the New General Self-Efficacy Scale (NGSE) at 4 Months.(at baseline and 4 months)
- Change From Baseline in Lifestyle Risk on the HALT-AD Lifestyle Risk Assessment Survey at 4 Months(at baseline and 4 months)