Trial Outcomes & Findings for "Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program" (NCT NCT05350410)
NCT ID: NCT05350410
Last Updated: 2024-08-15
Results Overview
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
COMPLETED
NA
20 participants
4 months
2024-08-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
"Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program"
Baseline characteristics by cohort
| Measure |
HALT-AD
n=20 Participants
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.
|
|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
|
Sex: Female, Male
Female
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13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown or prefer not to answer
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
|
Gender Identity
Female
|
13 Participants
n=99 Participants
|
|
Gender Identity
Male
|
7 Participants
n=99 Participants
|
|
Educational Attainment
Some high school
|
1 Participants
n=99 Participants
|
|
Educational Attainment
GED
|
1 Participants
n=99 Participants
|
|
Educational Attainment
Technical school or community college
|
1 Participants
n=99 Participants
|
|
Educational Attainment
Some university
|
2 Participants
n=99 Participants
|
|
Educational Attainment
Undergraduate degree at university
|
6 Participants
n=99 Participants
|
|
Educational Attainment
Some graduate (post-undergraduate school)
|
1 Participants
n=99 Participants
|
|
Educational Attainment
Graduate degree at university
|
8 Participants
n=99 Participants
|
|
Geographic Area
Urban
|
15 Participants
n=99 Participants
|
|
Geographic Area
Suburban
|
5 Participants
n=99 Participants
|
|
Marital Status
Single
|
2 Participants
n=99 Participants
|
|
Marital Status
Married
|
10 Participants
n=99 Participants
|
|
Marital Status
Domestic partnership
|
2 Participants
n=99 Participants
|
|
Marital Status
Divorced
|
4 Participants
n=99 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=99 Participants
|
|
Housing type
House or apartment/condominium that you own
|
11 Participants
n=99 Participants
|
|
Housing type
Apartment/condominium or house that you rent
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 monthsUser engagement with the HALT-AD online platform by measuring the average total amount of time (in minutes) spent per user on all courses combined
Outcome measures
| Measure |
HALT-AD
n=19 Participants
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.
|
|---|---|
|
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
Interval 48.5 to 244.0
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PRIMARY outcome
Timeframe: 4 monthsUsers' engagement with the HALT-AD online platform by measuring the percentage of participants who completed all courses.
Outcome measures
| Measure |
HALT-AD
n=19 Participants
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.
|
|---|---|
|
Users' Engagement With the HALT-AD Online Platform by Measuring the Percentage of Participants Who Completed All Courses.
|
10 Participants
|
SECONDARY outcome
Timeframe: at baseline and 4 monthsPopulation: 14 out of 19 participants had completed the HALT-AD knowledge assessment survey at the end of the study
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.
Outcome measures
| Measure |
HALT-AD
n=14 Participants
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.
|
|---|---|
|
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
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SECONDARY outcome
Timeframe: at baseline and 4 monthsPopulation: 14 out of 19 participants had completed the HALT-AD New General Self-Efficacy Scale (NGSE) survey at the end of the study
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.
Outcome measures
| Measure |
HALT-AD
n=14 Participants
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.
|
|---|---|
|
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
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SECONDARY outcome
Timeframe: at baseline and 4 monthsPopulation: 14 out of 19 participants completed the HALT-AD lifestyle risk assessment survey at the end of the study
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.
Outcome measures
| Measure |
HALT-AD
n=14 Participants
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.
|
|---|---|
|
Change From Baseline in Lifestyle Risk on the HALT-AD Lifestyle Risk Assessment Survey at 4 Months
|
1 score on a scale
Interval -0.75 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: completed at 4 monthsQualitative evaluation of participant responses on the HALT-AD Course Acceptability Survey completed at 4 months
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 monthsQualitative evaluation of participant responses during the focus group discussion
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 monthsQualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 monthsQualitative evaluation of participant responses during the focus group-discussion groups
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 monthsUsers 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).
Outcome measures
Outcome data not reported
Adverse Events
HALT-AD
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sara Moukarzel, PhD, Program Manager
Alzheimer's Disease Cooperative Study
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place