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"Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program" (HALT-AD)

Primary Purpose

Dementia, Alzheimer's Disease, Dementia Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HALT-AD
Sponsored by
Alzheimer's Disease Cooperative Study (ADCS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia focused on measuring dementia, prevention, education, lifestyle modification, digital health

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alzheimer's Disease Cooperative Study (ADCS)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HALT-AD

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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
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.
Users' satisfaction with the facilitated support discussion groups
Description: Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey
Qualitative evaluation of participant responses during the focus group discussion groups
Description: Qualitative evaluation of participant responses during the focus group discussion

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
April 6, 2022
Last Updated
November 10, 2022
Sponsor
Alzheimer's Disease Cooperative Study (ADCS)
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1. Study Identification

Unique Protocol Identification Number
NCT05350410
Brief Title
"Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program"
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alzheimer's Disease Cooperative Study (ADCS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer's Disease, Dementia Prevention
Keywords
dementia, prevention, education, lifestyle modification, digital health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HALT-AD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HALT-AD
Intervention Description
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
Primary Outcome Measure Information:
Title
Usability of the HALT-AD program
Description
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).
Time Frame
4 months
Title
Users' engagement with the HALT-AD online platform measuring completion of program assessments
Description
User engagement including the percentage of users who started the course, completed the course and passed the course.
Time Frame
4 months
Title
Users' engagement with the HALT-AD online platform measuring the average time spent per user on the course
Description
User engagement measuring the average time spent per user on the course.
Time Frame
4 months
Title
Acceptability Survey- Users' acceptability of the HALT-AD program content
Description
Qualitative evaluation of participant responses on the HALT-AD Course Acceptability Survey completed at 4 months
Time Frame
completed at 4 months
Title
FOCUS Group discussion- Qualitative evaluation of the HALT-AD program content
Description
Qualitative evaluation of participant responses during the focus group discussion completed at 4 months.
Time Frame
4 months
Title
Users' satisfaction with the facilitated support discussion groups
Description
Description: Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey
Time Frame
4 months
Title
Qualitative evaluation of participant responses during the focus group discussion groups
Description
Description: Qualitative evaluation of participant responses during the focus group discussion
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change from baseline in knowledge on the HALT-AD knowledge assessment survey at 4 months
Description
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)
Time Frame
at baseline and 4 months
Title
Change from baseline in self-efficacy on the New General Self-Efficacy Scale (NGSE) at 4 months.
Description
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)
Time Frame
at baseline and 4 months
Title
Change from baseline in lifestyle risk on the HALT-AD lifestyle risk assessment survey at 4 months
Description
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)
Time Frame
at baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Feldman, MDCM FRCP(C)
Organizational Affiliation
Alzheimer's Disease Cooperative Study (ADCS)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sarah Banks, PhD, ABPP-CN
Organizational Affiliation
Alzheimer's Disease Cooperative Study (ADCS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzheimer's Disease Cooperative Study (ADCS)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

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

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