Alzheimer's Disease Cooperative Study (ADCS)
La Jolla, California, 92037, United States
NCT Number: NCT05350410
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.
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Notify Me50 year–85 year
All sexes
Interventional
Not applicable
La Jolla, California, 92037, United States
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:
a) knowledge, b) self-efficacy, and c) dementia-related lifestyle risk factors
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HALT-AD is an online educational program designed to teach about dementia and lifestyle changes that can help preserve brain health and lower dementia risk. Participants complete online courses and engage in facilitated discussion groups.
Time frame: 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
Time frame: 4 months
Users' engagement with the HALT-AD online platform by measuring the percentage of participants who completed all courses.
Time frame: at baseline and 4 months
The HALT-AD knowledge assessment survey is developed based on the HALT-AD program content to assess general knowledge of dementia including risk factors, brain health and prevention. Possible scores range from 0 (all answers are incorrect) to 20 (all answers are correct), with higher scores indicating greater knowledge of dementia. Change = (4 months score - baseline score). The greater the change in score, the greater the increase in knowledge of dementia.
Time frame: at baseline and 4 months
The NGSE is an 8-item validated instrument assessing self-efficacy. Using a 5-point rating scale (1= strongly disagree to 5= strongly agree), participants report how much they believe they can achieve their goals. Total score for each participant is calculated by taking the mean of their ratings on each item, with the total possible score ranging from 1 to 5 and higher scores indicating greater self-efficacy. Change = (4 months score - baseline score). The greater the change in score, the greater the increase in self-efficacy.
Time frame: at baseline and 4 months
The HALT-AD lifestyle risk assessment survey is developed by the HALT-AD subject- matter expert team to assess adherence to a potentially dementia risk-reducing lifestyle. Possible scores range from 3 (very high risk) to 15 (very low risk). Change = (4 months total score - baseline total score). The greater the change in score, the greater the increase in adherence to a potentially dementia risk-reducing lifestyle.
Time frame: completed at 4 months
Qualitative evaluation of participant responses on the HALT-AD Course Acceptability Survey completed at 4 months
Time frame: 4 months
Qualitative evaluation of participant responses during the focus group discussion
Time frame: 4 months
Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey
Time frame: 4 months
Qualitative evaluation of participant responses during the focus group-discussion groups
Time frame: 4 months
Users will complete the HALT-AD User Experience survey which is adapted for HALT-AD based on questions from the User Experience Questionnaire (UEQ) available at https://ueqtryitout.ueq-research.org/. Participants will be asked to decide as spontaneously as possible which conflicting terms (e.g. annoying vs. enjoyable) better describes the HALT-AD program. Additionally, users will complete the Net Promoter Score Survey (NPS) which asks one question "How likely is it that you would recommend HALT-AD to a friend or colleague?" and is reported on a scale of -100 (extremely unlikely) to +100 (extremely likely).
Alzheimer's Disease Cooperative Study (ADCS)
Other
A Pilot Study for the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program (HALT-AD)
Acronym: HALT-AD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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