Clinical trial NCT05350410: "Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program"
Official title: A Pilot Study for the Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program (HALT-AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer's Disease
Dementia Prevention
Keywords: dementia
prevention
education
lifestyle modification
digital health
Lead sponsor: Alzheimer's Disease Cooperative Study (ADCS)
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent must be obtained and documented (from the participant).
2. Sufficient proficiency in English or Spanish to undergo clinical assessment and participate in an online educational program.
3. Ages 50-85
4. Montreal Cognitive Assessment-Telephone/Blind Version (T-MoCA) score ≥18/22
5. 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)
6. Sufficient vision and hearing to participate in online educational program (judgement of site investigator)
7. Ability to sit comfortably for a period of at least 30 minutes

Exclusion Criteria:

1. 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.
2. Individuals where English or Spanish is not sufficiently proficient for clinical assessment, and participation in a web-based educational program.
3. Participants who do not have sufficient vision and hearing to participate in an online educational program
4. 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)
5. Total Score on the T-MoCA \<18
6. 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.

Primary outcomes:
measure: Users' Engagement With the HALT-AD Online Platform by Measuring the Total Amount of Time (in Minutes) Spent Per User on All Courses Combined
timeFrame: 4 months
measure: Users' Engagement With the HALT-AD Online Platform by Measuring the Percentage of Participants Who Completed All Courses.
timeFrame: 4 months
Secondary outcomes:
measure: Change From Baseline in Knowledge on the HALT-AD Knowledge Assessment Survey at 4 Months
timeFrame: at baseline and 4 months
measure: Change From Baseline in Self-efficacy on the New General Self-Efficacy Scale (NGSE) at 4 Months.
timeFrame: at baseline and 4 months
measure: Change From Baseline in Lifestyle Risk on the HALT-AD Lifestyle Risk Assessment Survey at 4 Months
timeFrame: at baseline and 4 months
Other outcomes:
measure: Acceptability Survey- Users' Acceptability of the HALT-AD Program Content
timeFrame: completed at 4 months
measure: FOCUS Group Discussion- Qualitative Evaluation of the HALT-AD Program Content
timeFrame: 4 months
measure: Users' Satisfaction With the Facilitated Support Discussion Groups
timeFrame: 4 months
measure: Qualitative Evaluation of Participant Responses During the Focus Group Discussion Groups
timeFrame: 4 months
measure: Usability of the HALT-AD Program
timeFrame: 4 months
Locations:
city: La Jolla
country: United States
facility: Alzheimer's Disease Cooperative Study (ADCS)
state: California
Study officials:
affiliation: Alzheimer's Disease Cooperative Study (ADCS)
name: Howard Feldman, MDCM FRCP(C)
role: STUDY_DIRECTOR
affiliation: Alzheimer's Disease Cooperative Study (ADCS)
name: Sarah Banks, PhD, ABPP-CN
role: PRINCIPAL_INVESTIGATOR
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