DementiaHALT-ADNCT05350410
"Healthy Actions and Lifestyles to Avoid Dementia or Hispanos y el ALTo a la Demencia Program"
A study testing HALT-AD in people with Dementia and Alzheimer's Disease, run by Alzheimer's Disease Cooperative Study (ADCS) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer's Disease, Dementia Prevention
- What is being tested?
- HALT-AD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 24 Aug 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alzheimer's Disease Cooperative Study (ADCS)
La Jolla, California, 92037
About this study
Official title: 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.
Read the 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:
- To evaluate engagement with- the online platform
- To evaluate preliminary evidence on the effectiveness of the program in changing
- 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
- Conditions
- Dementia, Alzheimer's Disease, Dementia Prevention
- Being tested
- HALT-AD
- Keywords
- dementia, prevention, education, lifestyle modification, digital health
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALT-ADBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HALT-AD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start5 Apr 2022
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzheimer's Disease Cooperative Study (ADCS)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Feldman, MDCM FRCP(C), Study director, Alzheimer's Disease Cooperative Study (ADCS)Sarah Banks, PhD, ABPP-CN, Principal investigator, Alzheimer's Disease Cooperative Study (ADCS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350410
- Sponsor's protocol ID
- HALT-AD
- Acronym
- HALT-AD
- Status last verified
- Jul 2023
- First submitted
- 6 Apr 2022
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 286059992020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020 Mar 10. doi: 10.1002/alz.12068. Online ahead of print.
PubMed 32157811Hurd 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.
PubMed 23550670Agency, 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.
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.
PubMed 29450072Cummings 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.
PubMed 29955663Livingston 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.
PubMed 28735855Kivipelto 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.
PubMed 23332672Cummings 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.
PubMed 30175227Pendlebury 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.
PubMed 23138443Chen, 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.