"Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program" (HALT-AD)

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer's Disease; Dementia Prevention
• Intervention / Treatment: Behavioral: HALT-AD

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Alzheimer's Disease Cooperative Study (ADCS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Alzheimer's Disease Cooperative Study (ADCS)
• Investigators: Study Director: Howard Feldman, MDCM FRCP(C), Alzheimer's Disease Cooperative Study (ADCS); Principal Investigator: Sarah Banks, PhD, ABPP-CN, Alzheimer's Disease Cooperative Study (ADCS)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 2020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020 Mar 10. doi: 10.1002/alz.12068. Online ahead of print.
• 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.
• 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.
• Living, A.f.C., Profile of Older Americans. 2019.
• Network, U.E.R.R.I.o.A.L.s., Latinos and Alzheimer's Disease: New Numbers Behind the Crisis. 2016.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: dementia; prevention; digital health; education; lifestyle modification
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: HALT-AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No