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

NCT05350410 | Completed Results DMC

• 1 other identifier: HALT-AD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimer's Disease; Dementia Prevention

Keywords

dementia; prevention; education; lifestyle modification; digital health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change From Baseline in Knowledge on the HALT-AD Knowledge Assessment Survey at 4 Months

  at baseline and 4 months

• Change From Baseline in Self-efficacy on the New General Self-Efficacy Scale (NGSE) at 4 Months.

  at baseline and 4 months

• Change From Baseline in Lifestyle Risk on the HALT-AD Lifestyle Risk Assessment Survey at 4 Months

  at baseline and 4 months

Other Outcomes (5)

• Acceptability Survey- Users' Acceptability of the HALT-AD Program Content

  completed at 4 months

• FOCUS Group Discussion- Qualitative Evaluation of the HALT-AD Program Content

  4 months

• Users' Satisfaction With the Facilitated Support Discussion Groups

  4 months

Study Arms (1)

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.

Behavioral: HALT-AD

Interventions

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.

HALT-AD

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained and documented (from the participant).
• Sufficient proficiency in English or Spanish to undergo clinical assessment and participate in an online educational program.
• Ages 50-85
• Montreal Cognitive Assessment-Telephone/Blind Version (T-MoCA) score ≥18/22
• 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)
• Sufficient vision and hearing to participate in online educational program (judgement of site investigator)
• Ability to sit comfortably for a period of at least 30 minutes

You may not qualify if:

• 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.
• Individuals where English or Spanish is not sufficiently proficient for clinical assessment, and participation in a web-based educational program.
• Participants who do not have sufficient vision and hearing to participate in an online educational program
• 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)
• Total Score on the T-MoCA \<18
• 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.

Sponsors & Collaborators

• Alzheimer's Disease Cooperative Study (ADCS): lead

Study Sites (1)

Alzheimer's Disease Cooperative Study (ADCS)

La Jolla, California, 92037, United States

Location

Related Publications (14)

• 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.

  PMID: 28605999 BACKGROUND

• 2020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020 Mar 10. doi: 10.1002/alz.12068. Online ahead of print.

  PMID: 32157811 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.

  PMID: 23550670 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.

  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.

  PMID: 29450072 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.

  PMID: 29955663 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.

  PMID: 28735855 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.

  PMID: 23332672 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.

  PMID: 30175227 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.

  PMID: 23138443 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.

  BACKGROUND

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Sara Moukarzel, PhD, Program Manager
• Organization: Alzheimer's Disease Cooperative Study

smoukarzel@health.ucsd.edu

(858) 432-8828

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 28, 2022
• Study Start: April 5, 2022
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)