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

Not Applicable

Completed

Conditions: Alzheimer's Disease
Dementia Prevention
Dementia

Interventions: Behavioral: HALT-AD

Registration Number: NCT05350410

Lead Sponsor: Alzheimer's Disease Cooperative Study (ADCS)

Brief Summary: 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.

Detailed Description: 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:

1. To evaluate engagement with- the online platform

2. To evaluate preliminary evidence on the effectiveness of the program in changing

a) knowledge, b) self-efficacy, and c) dementia-related lifestyle risk factors

3. To determine users' acceptability of the program content

4. To determine users' acceptability and satisfaction with the facilitated support discussion groups

5. To evaluate the usability of the online platform

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HALT-AD	HALT-AD	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.

Primary Outcome Measures

Name	Time	Method
Users' Engagement With the HALT-AD Online Platform by Measuring the Percentage of Participants Who Completed All Courses.	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	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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Knowledge on the HALT-AD Knowledge Assessment Survey at 4 Months	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.
Change From Baseline in Self-efficacy on the New General Self-Efficacy Scale (NGSE) at 4 Months.	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.
Change From Baseline in Lifestyle Risk on the HALT-AD Lifestyle Risk Assessment Survey at 4 Months	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.