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Completed

NCT Number: NCT05350410

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alzheimer's Disease Cooperative Study (ADCS)

La Jolla, California, 92037, United States

About this study

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 engagement with- the online platform
  • To evaluate preliminary evidence on the effectiveness of the program in changing

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

  • To determine users' acceptability of the program content
  • To determine users' acceptability and satisfaction with the facilitated support discussion groups
  • To evaluate the usability of the online platform

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HALT-AD

Behavioral

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 outcomes

  1. Users' Engagement With the HALT-AD Online Platform by Measuring the Total Amount of Time (in Minutes) Spent Per User on All Courses Combined

    Time frame: 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

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

    Time frame: 4 months

    Users' engagement with the HALT-AD online platform by measuring the percentage of participants who completed all courses.

Secondary outcomes

  1. Change From Baseline in Knowledge on the HALT-AD Knowledge Assessment Survey at 4 Months

    Time frame: 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.

  2. Change From Baseline in Self-efficacy on the New General Self-Efficacy Scale (NGSE) at 4 Months.

    Time frame: 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.

  3. Change From Baseline in Lifestyle Risk on the HALT-AD Lifestyle Risk Assessment Survey at 4 Months

    Time frame: 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.

Other outcomes

  1. Acceptability Survey- Users' Acceptability of the HALT-AD Program Content

    Time frame: completed at 4 months

    Qualitative evaluation of participant responses on the HALT-AD Course Acceptability Survey completed at 4 months

  2. FOCUS Group Discussion- Qualitative Evaluation of the HALT-AD Program Content

    Time frame: 4 months

    Qualitative evaluation of participant responses during the focus group discussion

  3. Users' Satisfaction With the Facilitated Support Discussion Groups

    Time frame: 4 months

    Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey

  4. Qualitative Evaluation of Participant Responses During the Focus Group Discussion Groups

    Time frame: 4 months

    Qualitative evaluation of participant responses during the focus group-discussion groups

  5. Usability of the HALT-AD Program

    Time frame: 4 months

    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 complete the Net Promoter Score Survey (NPS) which asks one question "How likely is it that you would recommend HALT-AD to a friend or colleague?" and is reported on a scale of -100 (extremely unlikely) to +100 (extremely likely).

Sponsors and collaborators

Lead sponsor

Alzheimer's Disease Cooperative Study (ADCS)

Other

Registry information

Official study title

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

Acronym: HALT-AD

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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