Alzheimer's Disease, Dementia, Dementia Prevention
Conditions
Keywords
dementia, prevention, education, lifestyle modification, digital health
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
Interventions
BEHAVIORALHALT-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.
Sponsors
Alzheimer's Disease Cooperative Study (ADCS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Evaluation of Participant Responses During the Focus Group Discussion Groups | 4 months | Qualitative evaluation of participant responses during the focus group-discussion groups |
| FOCUS Group Discussion- Qualitative Evaluation of the HALT-AD Program Content | 4 months | Qualitative evaluation of participant responses during the focus group discussion |
| Acceptability Survey- Users' Acceptability of the HALT-AD Program Content | completed at 4 months | Qualitative evaluation of participant responses on the HALT-AD Course Acceptability Survey completed at 4 months |
| Users' Satisfaction With the Facilitated Support Discussion Groups | 4 months | Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey |
| Usability of the HALT-AD Program | 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). |
Countries
United States
Participant flow
Recruitment details
Cognitively normal midlife and older-adult participants were eligible to participate in this single arm pilot study. A total of 20 participants were enrolled at University of California San Diego. Recruitment began in March 2022 and the last participant exited the study August 2022. One participant withdrew from the study early.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HALT-AD |
|---|---|
| Age, Continuous | 70.1 years STANDARD_DEVIATION 10.2 |
| Educational Attainment GED | 1 Participants |
| Educational Attainment Graduate degree at university | 8 Participants |
| Educational Attainment Some graduate (post-undergraduate school) | 1 Participants |
| Educational Attainment Some high school | 1 Participants |
| Educational Attainment Some university | 2 Participants |
| Educational Attainment Technical school or community college | 1 Participants |
| Educational Attainment Undergraduate degree at university | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Gender Identity Female | 13 Participants |
| Gender Identity Male | 7 Participants |
| Geographic Area Suburban | 5 Participants |
| Geographic Area Urban | 15 Participants |
| Housing type Apartment/condominium or house that you rent | 9 Participants |
| Housing type House or apartment/condominium that you own | 11 Participants |
| Marital Status Divorced | 4 Participants |
| Marital Status Domestic partnership | 2 Participants |
| Marital Status Married | 10 Participants |
| Marital Status Single | 2 Participants |
| Marital Status Widowed | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Latin American | 5 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants |
| Race/Ethnicity, Customized Unknown or prefer not to answer | 1 Participants |
| Race/Ethnicity, Customized White | 12 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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 percentage of participants who completed all courses.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HALT-AD | Users' Engagement With the HALT-AD Online Platform by Measuring the Percentage of Participants Who Completed All Courses. | 10 Participants |
Primary
Users' Engagement With the HALT-AD Online Platform by Measuring the Total Amount of Time (in Minutes) Spent Per User on All Courses Combined
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
Time frame: 4 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HALT-AD | Users' Engagement With the HALT-AD Online Platform by Measuring the Total Amount of Time (in Minutes) Spent Per User on All Courses Combined | 136 minutes |
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), 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.
Time frame: at baseline and 4 months
Population: 14 out of 19 participants had completed the HALT-AD knowledge assessment survey at the end of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HALT-AD | Change From Baseline in Knowledge on the HALT-AD Knowledge Assessment Survey at 4 Months | 1.18 score on a scale | Standard Deviation 1.83 |
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 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.
Time frame: at baseline and 4 months
Population: 14 out of 19 participants completed the HALT-AD lifestyle risk assessment survey at the end of the study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HALT-AD | Change From Baseline in Lifestyle Risk on the HALT-AD Lifestyle Risk Assessment Survey at 4 Months | 1 score on a scale |
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, 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.
Time frame: at baseline and 4 months
Population: 14 out of 19 participants had completed the HALT-AD New General Self-Efficacy Scale (NGSE) survey at the end of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HALT-AD | Change From Baseline in Self-efficacy on the New General Self-Efficacy Scale (NGSE) at 4 Months. | 0.1 score on a scale | Standard Deviation 0.5 |
Other Pre-specified
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
Time frame: completed at 4 months
Other Pre-specified
FOCUS Group Discussion- Qualitative Evaluation of the HALT-AD Program Content
Qualitative evaluation of participant responses during the focus group discussion
Time frame: 4 months
Other Pre-specified
Qualitative Evaluation of Participant Responses During the Focus Group Discussion Groups
Qualitative evaluation of participant responses during the focus group-discussion groups
Time frame: 4 months
Other Pre-specified
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 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).
Time frame: 4 months
Other Pre-specified
Users' Satisfaction With the Facilitated Support Discussion Groups
Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey
Time frame: 4 months