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

Dementia Clinical Trial

— HALT-AD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05350410
• Other study ID #: HALT-AD
• Status: Completed
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: August 24, 2022

Study information

• Verified date: November 2022
• Source: Alzheimer's Disease Cooperative Study (ADCS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 the usability of, and engagement with, the online platform

2. To determine users' acceptability of:

1. HALT AD program content

2. facilitated support discussion groups

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

1. knowledge,

2. self-efficacy, and

3. dementia-related lifestyle risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Other:
• HALT-AD
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

Locations

Country	Name	City	State
United States	Alzheimer's Disease Cooperative Study (ADCS)	La Jolla	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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