Protocol for the Brain Health Support Program Study of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP): A Prospective 12-Month Intervention Study

被引：19

作者：

Feldman, H. H. ^{[1
,2
,13
]}

Belleville, S. ^{[3
,4
]}

Nygaard, H. B. ^{[5
]}

Montero-Odasso, M. ^{[6
,7
]}

Durant, J. ^{[1
,2
]}

Lupo, J. -L. ^{[1
,2
]}

Revta, C. ^{[1
,2
]}

Chan, S. ^{[8
]}

Cuesta, M. ^{[3
]}

Slack, P. J. ^{[5
]}

Winer, S. ^{[9
]}

Brewster, P. W. H. ^{[9
]}

Hofer, S. M. ^{[9
]}

Lim, A. ^{[10
]}

Centen, A. ^{[10
]}

Jacobs, D. M. ^{[1
,2
]}

Anderson, N. D. ^{[8
]}

Walker, J. D. ^{[11
]}

Speechley, M. R. ^{[12
]}

Zou, G. Y. ^{[12
]}

Chertkow, H. ^{[8
]}

机构：

[1] Univ Calif San Diego, Dept Neurosci, La Jolla, CA 92037 USA

[2] Univ Calif San Diego, Alzheimers Dis Cooperat Study, La Jolla, CA 92037 USA

[3] Ctr Rech Inst Univ Geriatrie CIUSSS Ctr Sud Ile M, Montreal, PQ, Canada

[4] Univ Montreal, Montreal, PQ, Canada

[5] Univ British Columbia, Div Neurol, Vancouver, BC, Canada

[6] Parkwood Inst, Lawson Hlth Res Inst, Gait & Brain Lab, London, ON, Canada

[7] Univ Western Ontario, Schulich Sch Med & Dent, Dept Med Geriatr, London, ON, Canada

[8] Univ Toronto, Rotman Res Inst & Baycrest Hlth Sci, Toronto, ON, Canada

[9] Univ Victoria, Inst Aging & Lifelong Hlth, Cognit & Technol Res Grp, Victoria, BC, Canada

[10] Sunnybrook Res Inst, Toronto, ON, Canada

[11] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada

[12] Univ Western Ontario, Schulich Sch Med & Dent, Dept Epidemiol & Biostat, London, ON, Canada

[13] Univ Calif San Diego, 9500 Gilman Dr,MC 0949, La Jolla, CA 92037 USA

来源：

JPAD-JOURNAL OF PREVENTION OF ALZHEIMERS DISEASE | 2023年 / 10卷 / 4期

基金：

加拿大健康研究院;

关键词：

Alzheimer's disease; dementia; prevention; Brain Health PRO; NCT05347966; ALZHEIMERS;

D O I：

10.14283/jpad.2023.65

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background/ObjectivesCAN-THUMBS UP is designed as a comprehensive and innovative fully remote program to 1) develop an interactive and compelling online Brain Health Support Program intervention, with potential to positively influence dementia literacy, self-efficacy and lifestyle risk factors; 2) enroll and retain a community-dwelling Platform Trial Cohort of individuals at risk of dementia who will participate in the intervention; 3) support an open platform trial to test a variety of multidomain interventions that might further benefit individuals at risk of dementia. This manuscript presents the Brain Health Support Program Study protocol.Design/SettingTwelve-month prospective multi-center longitudinal study to evaluate a fully remote web-based educational intervention. Participants will subsequently be part of a Platform Trial Cohort and may be eligible to participate in further dementia prevention clinical trials.ParticipantsThree hundred fifty older adults who are cognitively unimpaired or have mild cognitive impairment, with at least 1 well established dementia risk factor.InterventionParticipants engage in the Brain Health Support Program intervention for 45-weeks and complete pre/post intervention measures. This intervention is designed to convey best available evidence for dementia prevention, consists of 181 chapters within 8 modules that are progressively delivered, and is available online in English and French. The program has been developed as a collaborative effort by investigators with recognized expertise in the program's content areas, along with input from older-adult citizen advisors.MeasurementsThis study utilizes adapted remote assessments with accessible technologies (e.g. videoconferencing, cognitive testing via computer and mobile phone, wearable devices to track physical activity and sleep, self-administered saliva sample collection). The primary outcome is change in dementia literacy, as measured by the Alzheimer's Disease Knowledge Scale. Secondary outcomes include change in self-efficacy; engagement using the online program; user satisfaction ratings; and evaluation of usability and acceptance. Exploratory outcomes include changes in attitudes toward dementia, modifiable risk factors, performance on the Neuropsychological Test Battery, performance on self-administered online cognitive assessments, and levels of physical activity and sleep; success of the national recruitment plan; and the distribution of age adjusted polygenic hazard scores.ConclusionsThis fully remote study provides an accessible approach to research with all study activities being completed in the participants' home environment. This approach may reduce barriers to participation, provide an easier and less demanding participant experience, and reach a broader geography with recruitment from all regions of Canada. CAN-THUMBS UP represents a Canadian contribution to the global World-Wide FINGERS program (alz.org/wwfingers).

引用

页码：875 / 885

页数：11

共 26 条

[11] Genetic assessment of age-associated Alzheimer disease risk: Development and validation of a polygenic hazard score [J].

Desikan, Rahul S. ;

Fan, Chun Chieh ;

Wang, Yunpeng ;

Schork, Andrew J. ;

Cabra, Howard J., I ;

Cupples, L. Adrienne ;

Thompson, Wesley K. ;

Besser, Lilah ;

Kukull, Walter A. ;

Holland, Dominic ;

Chen, Chi-Hua ;

Brewer, James B. ;

Karow, David S. ;

Kauppi, Karolina ;

Witoelar, Aree ;

Karch, Celeste M. ;

Bonham, Luke W. ;

Yokoyama, Jennifer S. ;

Rosen, Howard J. ;

Miller, Bruce L. ;

Dillon, William P. ;

Wilson, David M. ;

Hess, Christopher P. ;

Pericak-Vance, Margaret ;

Haines, Jonathan L. ;

Farrer, Lindsay A. ;

Mayeux, Richard ;

Hardy, John ;

Goate, Alison M. ;

Hyman, Bradley T. ;

Schellenberg, Gerard D. ;

McEvoy, Linda K. ;

Andreassen, Ole A. ;

Dale, Anders M. .

PLOS MEDICINE, 2017, 14 (03)

[12] The crisis in recruitment for clinical trials in Alzheimer's and dementia: An action plan for solutions [J].

Fargo, Keith N. ;

Carrillo, Maria C. ;

Weiner, Michael W. ;

Potter, William Z. ;

Khachaturian, Zaven ;

Vradenburg, George ;

Weiner, Michael W. .

ALZHEIMERS & DEMENTIA, 2016, 12 (11) :1113-1115

[13]

Fitzsimmons Suzanne, 2003, Am J Alzheimers Dis Other Demen, V18, P282, DOI 10.1177/153331750301800504

[14] World-Wide FINGERS Network: A global approach to risk reduction and prevention of dementia [J].

Kivipelto, Miia ;

Mangialasche, Francesca ;

Snyder, Heather M. ;

Allegri, Ricardo ;

Andrieu, Sandrine ;

Arai, Hidenori ;

Baker, Laura ;

Belleville, Sylvie ;

Brodaty, Henry ;

Brucki, Sonia M. ;

Calandri, Ismael ;

Caramelli, Paulo ;

Chen, Christopher ;

Chertkow, Howard ;

Chew, Effie ;

Choi, Seong H. ;

Chowdhary, Neerja ;

Crivelli, Lucia ;

De La Torre, Rafael ;

Du, Yifeng ;

Dua, Tarun ;

Espeland, Mark ;

Feldman, Howard H. ;

Hartmanis, Maris ;

Hartmann, Tobias ;

Heffernan, Megan ;

Henry, Christiani J. ;

Hong, Chang H. ;

Hakansson, Krister ;

Iwatsubo, Takeshi ;

Jeong, Jee H. ;

Jimenez-Maggiora, Gustavo ;

Koo, Edward H. ;

Launer, Lenore J. ;

Lehtisalo, Jenni ;

Lopera, Francisco ;

Martinez-Lage, Pablo ;

Martins, Ralph ;

Middleton, Lefkos ;

Molinuevo, Jose L. ;

Montero-Odasso, Manuel ;

Moon, So Y. ;

Morales-Perez, Kristal ;

Nitrini, Ricardo ;

Nygaard, Haakon B. ;

Park, Yoo K. ;

Peltonen, Markku ;

Qiu, Chengxuan ;

Quiroz, Yakeel T. ;

Raman, Rema .

ALZHEIMERS & DEMENTIA, 2020, 16 (07) :1078-1094

[15] The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): Study design and progress [J].

Kivipelto, Miia ;

Solomon, Alina ;

Ahtiluoto, Satu ;

Ngandu, Tiia ;

Lehtisalo, Jenni ;

Antikainen, Riitta ;

Backman, Lars ;

Hanninen, Tuomo ;

Jula, Antti ;

Laatikainen, Tiina ;

Lindstrom, Jaana ;

Mangialasche, Francesca ;

Nissinen, Aulikki ;

Paajanen, Teemu ;

Pajala, Satu ;

Peltonen, Markku ;

Rauramaa, Rainer ;

Stigsdotter-Neely, Anna ;

Strandberg, Timo ;

Tuomilehto, Jaakko ;

Soininen, Hilkka .

ALZHEIMERS & DEMENTIA, 2013, 9 (06) :657-665

[16] Dementia prevention, intervention, and care: 2020 report of the Lancet Commission [J].

Livingston, Gill ;

Huntley, Jonathan ;

Sommerlad, Andrew ;

Ames, David ;

Ballard, Clive ;

Banerjee, Sube ;

Brayne, Carol ;

Burns, Alistair ;

Cohen-Mansfield, Jiska ;

Cooper, Claudia ;

Costafreda, Sergi G. ;

Dias, Amit ;

Fox, Nick ;

Gitlin, Laura N. ;

Howard, Robert ;

Kales, Helen C. ;

Kivimaki, Mika ;

Larson, Eric B. ;

Ogunniyi, Adesola ;

Orgeta, Vasiliki ;

Ritchie, Karen ;

Rockwood, Kenneth ;

Sampson, Elizabeth L. ;

Samus, Quincy ;

Schneider, Lon S. ;

Selbaek, Geir ;

Teri, Linda ;

Mukadam, Naaheed .

LANCET, 2020, 396 (10248) :413-446

[17] Dementia prevention, intervention, and care [J].

Livingston, Gill ;

Sommerlad, Andrew ;

Orgeta, Vasiliki ;

Costafreda, Sergi G. ;

Huntley, Jonathan ;

Ames, David ;

Ballard, Clive ;

Banerjee, Sube ;

Burns, Alistair ;

Cohen-Mansfield, Jiska ;

Cooper, Claudia ;

Fox, Nick ;

Gitlin, Laura N. ;

Howard, Robert ;

Kales, Helen C. ;

Larson, Eric B. ;

Ritchie, Karen ;

Rockwood, Kenneth ;

Sampson, Elizabeth L. ;

Samus, Quincy ;

Schneider, Lon S. ;

Selbaek, Geir ;

Teri, Linda ;

Mukadam, Naaheed .

LANCET, 2017, 390 (10113) :2673-2734

[18] Does analysis using "last observation carried forward" introduce bias in dementia research? [J].

Molnar, Frank J. ;

Hutton, Brian ;

Fergusson, Dean .

CANADIAN MEDICAL ASSOCIATION JOURNAL, 2008, 179 (08) :751-753

[19]

OSTBYE T, 1994, CAN MED ASSOC J, V151, P1457

[20] Accuracy of a Self-Administered Online Cognitive Assessment in Detecting Amnestic Mild Cognitive Impairment [J].

Paterson, Theone S. E. ;

Sivajohan, Brintha ;

Gardner, Sandra ;

Binns, Malcolm A. ;

Stokes, Kathryn A. ;

Freedman, Morris ;

Levine, Brian ;

Troyer, Angela K. .

JOURNALS OF GERONTOLOGY SERIES B-PSYCHOLOGICAL SCIENCES AND SOCIAL SCIENCES, 2022, 77 (02) :341-350

← 1 2 3 →