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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HALT-AD | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
| 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | completed at 4 months |
| FOCUS Group Discussion- Qualitative Evaluation of the HALT-AD Program Content |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Feldman, MDCM FRCP(C) | Alzheimer's Disease Cooperative Study (ADCS) | Study Director |
| Sarah Banks, PhD, ABPP-CN | Alzheimer's Disease Cooperative Study (ADCS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alzheimer's Disease Cooperative Study (ADCS) | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28605999 | Background | Ostergren JE, Heeringa SG, Leon CFM, Connell CM, Roberts JS. The Influence of Psychosocial and Cognitive Factors on Perceived Threat of Alzheimer's Disease. Am J Alzheimers Dis Other Demen. 2017 Aug;32(5):289-299. doi: 10.1177/1533317517714552. Epub 2017 Jun 13. | |
| 32157811 | Background | 2020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020 Mar 10. doi: 10.1002/alz.12068. Online ahead of print. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | minutes | 4 months |
|
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All-Cause Mortality, Serious, and Other(not including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (not including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Moukarzel, PhD, Program Manager | Alzheimer's Disease Cooperative Study | (858) 432-8828 | smoukarzel@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2023 | May 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2022 | Feb 22, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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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:
Aim to recruit 50% women and enroll a diverse participant sample across varied age ranges within both language groups
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| at baseline and 4 months |
| 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. | at baseline and 4 months |
| 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. | at baseline and 4 months |
Qualitative evaluation of participant responses during the focus group discussion |
| 4 months |
| Users' Satisfaction With the Facilitated Support Discussion Groups | Qualitative evaluation of participant responses on the HALT-AD Facilitated Discussion Group Acceptability Survey | 4 months |
| Qualitative Evaluation of Participant Responses During the Focus Group Discussion Groups | Qualitative evaluation of participant responses during the focus group-discussion groups | 4 months |
| 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). | 4 months |
| 23550670 | Background | Hurd MD, Martorell P, Delavande A, Mullen KJ, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Apr 4;368(14):1326-34. doi: 10.1056/NEJMsa1204629. |
| Background | Agency, C.o.S.D.H.a.H.S., The Alzheimer's Project Clinical Rountable. Alzheimer's disease and related dementias in San Diego county. 2018. |
| Background | Living, A.f.C., Profile of Older Americans. 2019. |
| Background | Network, U.E.R.R.I.o.A.L.s., Latinos and Alzheimer's Disease: New Numbers Behind the Crisis. 2016. |
| 29450072 | Background | Velasco-Mondragon E, Jimenez A, Palladino-Davis AG, Davis D, Escamilla-Cejudo JA. Hispanic health in the USA: a scoping review of the literature. Public Health Rev. 2016 Dec 7;37:31. doi: 10.1186/s40985-016-0043-2. eCollection 2016. |
| 29955663 | Background | Cummings J, Lee G, Ritter A, Zhong K. Alzheimer's disease drug development pipeline: 2018. Alzheimers Dement (N Y). 2018 May 3;4:195-214. doi: 10.1016/j.trci.2018.03.009. eCollection 2018. |
| 28735855 | Background | Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available. |
| 23332672 | Background | Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17. |
| 30175227 | Background | Cummings J, Reiber C, Kumar P. The price of progress: Funding and financing Alzheimer's disease drug development. Alzheimers Dement (N Y). 2018 Jun 13;4:330-343. doi: 10.1016/j.trci.2018.04.008. eCollection 2018. |
| 23138443 | Background | Pendlebury ST, Welch SJ, Cuthbertson FC, Mariz J, Mehta Z, Rothwell PM. Telephone assessment of cognition after transient ischemic attack and stroke: modified telephone interview of cognitive status and telephone Montreal Cognitive Assessment versus face-to-face Montreal Cognitive Assessment and neuropsychological battery. Stroke. 2013 Jan;44(1):227-9. doi: 10.1161/STROKEAHA.112.673384. Epub 2012 Nov 8. |
| Background | Chen, G., S.M. Gully, and D. Eden, Validation of a new general self-efficacy scale. Organizational research methods, 2001. 4(1): p. 62-83. |
| Background | Metlife Foundation. What America Thinks - Metlife Foundation Alzheimer's Survey. Available at: https://www.metlife.com/content/dam/microsites/about/corporateprofile/ alzheimers-2011.pdf. 2011. |
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| 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. | Posted | Count of Participants | Participants | 4 months |
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| 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. | 14 out of 19 participants had completed the HALT-AD knowledge assessment survey at the end of the study | Posted | Mean | Standard Deviation | score on a scale | at baseline and 4 months |
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| 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. | 14 out of 19 participants had completed the HALT-AD New General Self-Efficacy Scale (NGSE) survey at the end of the study | Posted | Mean | Standard Deviation | score on a scale | at baseline and 4 months |
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| 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. | 14 out of 19 participants completed the HALT-AD lifestyle risk assessment survey at the end of the study | Posted | Median | Inter-Quartile Range | score on a scale | at baseline and 4 months |
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| 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 | Not Posted | completed at 4 months | Participants |
| Other Pre-specified | FOCUS Group Discussion- Qualitative Evaluation of the HALT-AD Program Content | Qualitative evaluation of participant responses during the focus group discussion | Not Posted | 4 months | Participants |
| 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 | Not Posted | 4 months | Participants |
| 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 | Not Posted | 4 months | Participants |
| 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). | Not Posted | 4 months | Participants |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |