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Tytuł:
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Estimating the financial costs associated with a phase III, multi-site exercise intervention trial: Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE).
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Autorzy:
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Donahue PT; University of Pittsburgh, Pittsburgh, PA, USA; Johns Hopkins University, Baltimore, MD, USA. Electronic address: .
Grove G; University of Pittsburgh, Pittsburgh, PA, USA.
Stillman C; University of Pittsburgh, Pittsburgh, PA, USA.
Kang C; University of Pittsburgh, Pittsburgh, PA, USA.
Burns J; University of Kansas Medical Center, Kansas City, MO, USA.
Hillman CH; Northeastern University, Boston, MA, USA.
Kramer AF; Northeastern University, Boston, MA, USA; University of Illinois, Champaign, IL, USA.
McAuley E; University of Illinois, Champaign, IL, USA.
Vidoni E; University of Kansas Medical Center, Kansas City, MO, USA.
Erickson KI; University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: .
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Źródło:
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Contemporary clinical trials [Contemp Clin Trials] 2021 Jun; Vol. 105, pp. 106401. Date of Electronic Publication: 2021 Apr 18.
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Typ publikacji:
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Journal Article; Research Support, N.I.H., Extramural
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Język:
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English
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Imprint Name(s):
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Original Publication: New York, N.Y. : Elsevier, c2005-
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MeSH Terms:
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Exercise*
Neuroimaging*
Advertising ; Clinical Trials, Phase III as Topic ; Cost-Benefit Analysis ; Exercise Therapy ; Humans ; Magnetic Resonance Imaging ; Randomized Controlled Trials as Topic
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References:
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Obesity (Silver Spring). 2018 Dec;26(12):1893-1897. (PMID: 30358132)
Inj Epidemiol. 2014 Dec;1(1):5. (PMID: 27747670)
Curr Psychiatry Rep. 2018 Jul 24;20(8):63. (PMID: 30043270)
Contemp Clin Trials. 2019 Oct;85:105832. (PMID: 31465859)
J Gerontol A Biol Sci Med Sci. 2016 May;71(5):656-62. (PMID: 26888433)
JMIR Mhealth Uhealth. 2018 Mar 01;6(3):e47. (PMID: 29496655)
Clin Trials. 2016 Apr;13(2):117-26. (PMID: 26908540)
Contemp Clin Trials Commun. 2020 Dec;20:100666. (PMID: 33052319)
J Phys Act Health. 2009 Nov;6(6):767-74. (PMID: 20101920)
Cochrane Database Syst Rev. 2013 Sep 12;(9):CD004366. (PMID: 24026850)
Lancet. 2020 Aug 8;396(10248):413-446. (PMID: 32738937)
Med Sci Sports Exerc. 2019 Jun;51(6):1303-1313. (PMID: 31095087)
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Grant Information:
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R01 AG053952 United States AG NIA NIH HHS; T32 AG000247 United States AG NIA NIH HHS
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Contributed Indexing:
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Keywords: Aerobic exercise; Aging; Cognition; Neuroimaging; Physical activity; Randomized clinical trial
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Entry Date(s):
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Date Created: 20210415 Date Completed: 20210924 Latest Revision: 20220716
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Update Code:
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20240104
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PubMed Central ID:
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PMC8172438
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DOI:
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10.1016/j.cct.2021.106401
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PMID:
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33857678
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Introduction: Supervised exercise interventions are expensive and time intensive. However, there are financial costs to consider in addition to the intervention itself, namely: advertising and recruitment, outcome assessments, and other trial-related costs.
Objectives: In this analysis, we examine the financial costs associated with the administration of Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE) to quantify the costs associated with large exercise intervention trials and to provide future investigators with financial estimates if they wish to pursue studies of a similar design.
Methods: Cost per randomized participant were calculated in four areas: (1) advertising and recruitment, (2) outcome assessments, (3) delivery of the intervention, and (4) other trial-related expenses. Overall trial costs associated with data analysis, faculty salaries, and indirect costs were estimated as well.
Results: The total cost per randomized participant was estimated to be $16,494. Outcome assessments accounted for the highest proportion of per-participant (75%) and total trial (38%) costs. Neuroimaging assessments (MRI & PET) cost $8247 per randomized participant, accounting for two-thirds (67%) of outcome assessment costs and half (50%) of per-participant costs.
Conclusion: Large clinical trials of exercise are expensive (~$21 million), particularly when administering several visits to assess study aims. Outcome assessments, specifically those involving neuroimaging, accounted for a significant proportion of total costs in this analysis. Future investigators must budget accordingly if they wish to conduct a comprehensive, multi-site exercise intervention trial that examines numerous physiological and psychological outcomes.
(Copyright © 2021 Elsevier Inc. All rights reserved.)
