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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

4 months

Results posted on

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

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

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.
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

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

Baseline characteristics by cohort

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
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 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

Outcome measures

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

PRIMARY outcome

Timeframe: 4 months

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

Outcome measures

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 months

Population: 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

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

SECONDARY outcome

Timeframe: 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

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

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

SECONDARY outcome

Timeframe: 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

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

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 months

Qualitative 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 months

Qualitative evaluation of participant responses during the focus group discussion

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Qualitative 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 months

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

HALT-AD

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: (858) 432-8828

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place