Abstract
Introduction: There is an unmet need for effective methods for conducting dementia prevention trials. Methods: Home-based assessment study compared feasibility and efficiency, ability to capture change over time using in-home instruments, and ability to predict cognitive conversion using predefined triggers in a randomized clinical trial in (1)mail-in questionnaire/live telephone interviews, (2)automated telephone/interactive voice recognition, and (3)internet-based computer Kiosk technologies. Primary endpoint was defined as cognitive conversion. Results: Analysis followed a modified intent-to-treat principle. Dropout rates were low and similar across technologies but participants in Kiosk were more likely to dropout earlier. Staff resources needed were higher in Kiosk. In-home instruments distinguished conversion and stable groups. Cognitively stable group showed improvement in cognitive measures. Triggering was associated with higher likelihood of conversion but statistically significant only in mail-in questionnaire/live telephone interviews. Discussion: Relatively low efficiency of internet-based assessment compared with testing by live-assessors has implications for internet-based recruitment and assessment efforts currently proposed for diverse populations.
| Original language | English |
|---|---|
| Pages (from-to) | 615-624 |
| Number of pages | 10 |
| Journal | Alzheimer's and Dementia |
| Volume | 15 |
| Issue number | 5 |
| DOIs | |
| State | Published - May 2019 |
Keywords
- Alzheimer's disease
- Dementia prevention
- Home-based assessment
- Randomized clinical trial
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In: Alzheimer's and Dementia, Vol. 15, No. 5, 05.2019, p. 615-624.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - A randomized clinical trial to evaluate home-based assessment of people over 75 years old
AU - Alzheimer Disease Cooperative Study Investigators
AU - Sano, Mary
AU - Zhu, Carolyn W.
AU - Kaye, Jeffrey
AU - Mundt, James C.
AU - Hayes, Tamara L.
AU - Ferris, Steven
AU - Thomas, Ronald G.
AU - Sun, Chung Kai
AU - Jiang, Yanxin
AU - Donohue, Michael C.
AU - Schneider, Lon S.
AU - Egelko, Susan
AU - Aisen, Paul S.
AU - Feldman, Howard H.
N1 - Funding Information: Conflict of Interest: Mary Sano, Carolyn W. Zhu, James C. Mundt, Chung-Kai Sun, Yanxin Jiang, Michael C. Donohue, and Susan Egelko report no conflict of interest pertaining to the present study. Jeffrey Kaye receives research support from the NIH ( U2C AG054397 , P30 AG008017 , R01 AG024059 , P30 AG024978 , P01 AG043362 , U01 AG010483 ) and Merck ; directs a center that receives research support from the NIH , CDC , Alzheimer's Association , AbbVie , Kyowa , Glovia , and Eisai ; is compensated for serving on Data Safety Monitoring Committees for Eli Lilly and Suven; receives reimbursement through Medicare or commercial insurance plans for providing clinical assessment and care for patients; and serves on the editorial advisory board and as Associate Editor of the journal, Alzheimer's & Dementia and as Associate Editor of the Journal of Translational Engineering in Health and Medicine. Ronald G. Thomas receives research support from the National Institutes of Health ( U01 AG010483 ) and consultant fees from Toyama and vTv. Lon S. Schneider acknowledges support from NIH P50 AG05142 (USC ADRC) and from U01 AG10483 ( ADCS ). Paul Aisen has served as a consultant to the following companies: NeuroPhage, Elan, Eisai, Bristol-Myers Squibb, Eli Lilly, Merck, Roche, Amgen, Genentech, Abbott, Pfizer, Novartis, AstraZeneca, Janssen, Medivation, Ichor, Toyama, Lundbeck, Biogen Idec, iPerian, Probiodrug, Somaxon, Biotie, Cardeus, Anavex, AbbVie, and CohBar. Howard H. Feldman reports grants from National Institutes of Health : Alzheimer Disease Cooperative Study U19AG10483-26 , during the conduct of the study. Outside of the submitted work: grants from Lilly Pharmaceutical , service agreements with Eisai Pharmaceuticals, with Banner Institute and Genentech Pharmaceuticals, with Merck Pharmaceuticals, and with Tau Rx. Travel expenses received from Axon Neurosciences, Alion Pharmaceuticals, and Probiodrug. Lecture fees paid to UCSD by Medscape and Optum Health. Funding Information: Conflict of Interest: Mary Sano, Carolyn W. Zhu, James C. Mundt, Chung-Kai Sun, Yanxin Jiang, Michael C. Donohue, and Susan Egelko report no conflict of interest pertaining to the present study. Jeffrey Kaye receives research support from the NIH (U2C AG054397, P30 AG008017, R01 AG024059, P30 AG024978, P01 AG043362, U01 AG010483)and Merck; directs a center that receives research support from the NIH, CDC, Alzheimer's Association, AbbVie, Kyowa, Glovia, and Eisai; is compensated for serving on Data Safety Monitoring Committees for Eli Lilly and Suven; receives reimbursement through Medicare or commercial insurance plans for providing clinical assessment and care for patients; and serves on the editorial advisory board and as Associate Editor of the journal, Alzheimer's & Dementia and as Associate Editor of the Journal of Translational Engineering in Health and Medicine. Ronald G. Thomas receives research support from the National Institutes of Health (U01 AG010483)and consultant fees from Toyama and vTv. Lon S. Schneider acknowledges support from NIH P50 AG05142 (USC ADRC)and from U01 AG10483 (ADCS). Paul Aisen has served as a consultant to the following companies: NeuroPhage, Elan, Eisai, Bristol-Myers Squibb, Eli Lilly, Merck, Roche, Amgen, Genentech, Abbott, Pfizer, Novartis, AstraZeneca, Janssen, Medivation, Ichor, Toyama, Lundbeck, Biogen Idec, iPerian, Probiodrug, Somaxon, Biotie, Cardeus, Anavex, AbbVie, and CohBar. Howard H. Feldman reports grants from National Institutes of Health: Alzheimer Disease Cooperative Study U19AG10483-26, during the conduct of the study. Outside of the submitted work: grants from Lilly Pharmaceutical, service agreements with Eisai Pharmaceuticals, with Banner Institute and Genentech Pharmaceuticals, with Merck Pharmaceuticals, and with Tau Rx. Travel expenses received from Axon Neurosciences, Alion Pharmaceuticals, and Probiodrug. Lecture fees paid to UCSD by Medscape and Optum Health.This work was supported by the following grants from the National Institute of Health/National Institute on Aging: U01AG10483, P50AG005138, P30AG008051, and P30AG024978. Development of the Kiosk and MedTracker was supported in part by grants from NIA (P30- AG024978; P30-AG08017)and Intel Corporation. Drs. Sano and Zhu are also supported by the Department of Veterans Affairs, Veterans Health Administration. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. Funding Information: This work was supported by the following grants from the National Institute of Health / National Institute on Aging : U01AG10483 , P50AG005138 , P30AG008051, and P30AG024978 . Development of the Kiosk and MedTracker was supported in part by grants from NIA ( P30- AG024978 ; P30-AG08017 ) and Intel Corporation . Drs. Sano and Zhu are also supported by the Department of Veterans Affairs , Veterans Health Administration . The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. Funding Information: Conflict of Interest: Mary Sano, Carolyn W. Zhu, James C. Mundt, Chung-Kai Sun, Yanxin Jiang, Michael C. Donohue, and Susan Egelko report no conflict of interest pertaining to the present study. Jeffrey Kaye receives research support from the NIH (U2C AG054397, P30 AG008017, R01 AG024059, P30 AG024978, P01 AG043362, U01 AG010483) and Merck; directs a center that receives research support from the NIH, CDC, Alzheimer's Association, AbbVie, Kyowa, Glovia, and Eisai; is compensated for serving on Data Safety Monitoring Committees for Eli Lilly and Suven; receives reimbursement through Medicare or commercial insurance plans for providing clinical assessment and care for patients; and serves on the editorial advisory board and as Associate Editor of the journal, Alzheimer's & Dementia and as Associate Editor of the Journal of Translational Engineering in Health and Medicine. Ronald G. Thomas receives research support from the National Institutes of Health (U01 AG010483) and consultant fees from Toyama and vTv. Lon S. Schneider acknowledges support from NIH P50 AG05142 (USC ADRC) and from U01 AG10483 (ADCS). Paul Aisen has served as a consultant to the following companies: NeuroPhage, Elan, Eisai, Bristol-Myers Squibb, Eli Lilly, Merck, Roche, Amgen, Genentech, Abbott, Pfizer, Novartis, AstraZeneca, Janssen, Medivation, Ichor, Toyama, Lundbeck, Biogen Idec, iPerian, Probiodrug, Somaxon, Biotie, Cardeus, Anavex, AbbVie, and CohBar. Howard H. Feldman reports grants from National Institutes of Health: Alzheimer Disease Cooperative Study U19AG10483-26, during the conduct of the study. Outside of the submitted work: grants from Lilly Pharmaceutical, service agreements with Eisai Pharmaceuticals, with Banner Institute and Genentech Pharmaceuticals, with Merck Pharmaceuticals, and with Tau Rx. Travel expenses received from Axon Neurosciences, Alion Pharmaceuticals, and Probiodrug. Lecture fees paid to UCSD by Medscape and Optum Health.This work was supported by the following grants from the National Institute of Health/National Institute on Aging: U01AG10483, P50AG005138, P30AG008051, and P30AG024978. Development of the Kiosk and MedTracker was supported in part by grants from NIA (P30- AG024978; P30-AG08017) and Intel Corporation. Drs. Sano and Zhu are also supported by the Department of Veterans Affairs, Veterans Health Administration. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. Publisher Copyright: © 2019
PY - 2019/5
Y1 - 2019/5
N2 - Introduction: There is an unmet need for effective methods for conducting dementia prevention trials. Methods: Home-based assessment study compared feasibility and efficiency, ability to capture change over time using in-home instruments, and ability to predict cognitive conversion using predefined triggers in a randomized clinical trial in (1)mail-in questionnaire/live telephone interviews, (2)automated telephone/interactive voice recognition, and (3)internet-based computer Kiosk technologies. Primary endpoint was defined as cognitive conversion. Results: Analysis followed a modified intent-to-treat principle. Dropout rates were low and similar across technologies but participants in Kiosk were more likely to dropout earlier. Staff resources needed were higher in Kiosk. In-home instruments distinguished conversion and stable groups. Cognitively stable group showed improvement in cognitive measures. Triggering was associated with higher likelihood of conversion but statistically significant only in mail-in questionnaire/live telephone interviews. Discussion: Relatively low efficiency of internet-based assessment compared with testing by live-assessors has implications for internet-based recruitment and assessment efforts currently proposed for diverse populations.
AB - Introduction: There is an unmet need for effective methods for conducting dementia prevention trials. Methods: Home-based assessment study compared feasibility and efficiency, ability to capture change over time using in-home instruments, and ability to predict cognitive conversion using predefined triggers in a randomized clinical trial in (1)mail-in questionnaire/live telephone interviews, (2)automated telephone/interactive voice recognition, and (3)internet-based computer Kiosk technologies. Primary endpoint was defined as cognitive conversion. Results: Analysis followed a modified intent-to-treat principle. Dropout rates were low and similar across technologies but participants in Kiosk were more likely to dropout earlier. Staff resources needed were higher in Kiosk. In-home instruments distinguished conversion and stable groups. Cognitively stable group showed improvement in cognitive measures. Triggering was associated with higher likelihood of conversion but statistically significant only in mail-in questionnaire/live telephone interviews. Discussion: Relatively low efficiency of internet-based assessment compared with testing by live-assessors has implications for internet-based recruitment and assessment efforts currently proposed for diverse populations.
KW - Alzheimer's disease
KW - Dementia prevention
KW - Home-based assessment
KW - Randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85062597834&partnerID=8YFLogxK
U2 - 10.1016/j.jalz.2019.01.007
DO - 10.1016/j.jalz.2019.01.007
M3 - Article
C2 - 30872114
AN - SCOPUS:85062597834
SN - 1552-5260
VL - 15
SP - 615
EP - 624
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 5
ER -