Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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 the usability of, and engagement with, the online platform To determine users' acceptability of: HALT AD program content facilitated support discussion groups To evaluate preliminary evidence on the effectiveness of the program in changing knowledge, self-efficacy, and dementia-related lifestyle risk factors.

Official Title
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A Pilot Study for the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program (HALT-AD)

Conditions
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Dementia, Alzheimer's Disease, Dementia Prevention

Intervention / Treatment
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* Other: HALT-AD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Ages 50-85 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: 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. Cognitively normal midlife and older-adult participants will be eligible to participate in this pilot study with the following inclusion criteria: . Ages 50-85 Montreal Cognitive Assessment-Telephone/Blind version (T-MoCA) Score equal to or greater than 18/22 Sufficient proficiency in English or Spanish to undergo clinical assessment and participate Technical ability to participate Sufficient vision and hearing to participate 20 participants will be enrolled at UCSD 10 will complete the English version 10 will complete the Spanish version Aim to recruit 50% women and enroll a diverse participant sample across varied age ranges within both language groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HALT-AD<br>This arm includes cognitively normal midlife and older-adult participants with the following inclusion criteria: Signed informed consent must be obtained and documented (from the participant) Sufficient proficiency in English or Spanish to undergo clinical assessment and participate Ages 50-85 Montreal Cognitive Assessment-Telephone/Blind Version (T-MoCA) score ≥18/22 Technical ability to participate Sufficient vision and hearing to participate Ability to sit comfortably for a period of at least 30 minutes A total of 20 participants will be enrolled at UCSD 10 will complete the English version 10 will complete the Spanish version Aim is to recruit 50% women and to enroll a diverse participant sample across varied age ranges within both language groups. | Other: HALT-AD<br>* Prior studies have shown that programs that focus on promoting brain health and managing lifestyle risks (such as poor diet, obesity, physical inactivity, sleep issues, loneliness) may help in preventing or lowering the risk of dementia. To address this, we have developed the HALT-AD program. HALT-AD is an educational program designed to teach about dementia and lifestyle changes that can help preserve brain health and lower dementia risk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the HALT-AD program | 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 be asked one additional question How likely is it that you would recommend HALT-AD to a friend or colleague? on a scale of -100 (extremely unlikely) to +100 (extremely likely). | 4 months | 
| Users' engagement with the HALT-AD online platform measuring completion of program assessments | User engagement including the percentage of users who started the course, completed the course and passed the course. | 4 months | 
| Users' engagement with the HALT-AD online platform measuring the average time spent per user on the course | User engagement measuring the average time spent per user on the course. | 4 months | 
| Acceptability Survey- Users' acceptability of the HALT-AD program content | Qualitative evaluation of participant responses on the HALT-AD Course Acceptability Survey completed at 4 months | completed at 4 months | 
| FOCUS Group discussion- Qualitative evaluation of the HALT-AD program content | Qualitative evaluation of participant responses during the focus group discussion completed at 4 months. | 4 months | 
| Users' satisfaction with the facilitated support discussion groups | Description: Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey | 4 months | 
| Qualitative evaluation of participant responses during the focus group discussion groups | Description: Qualitative evaluation of participant responses during the focus group discussion | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in knowledge on the HALT-AD knowledge assessment survey at 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). Change = (4 months score - baseline score) | at baseline and 4 months | 
| Change from baseline in self-efficacy on the New General Self-Efficacy Scale (NGSE) at 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. Change = (4 months score - baseline score) | at baseline and 4 months | 
| Change from baseline in lifestyle risk on the HALT-AD lifestyle risk assessment survey at 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 vary by risk factor. Change = (4 months score - baseline score) | at baseline and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, prevention, education, lifestyle modification, digital health