AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients

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dc.citation.issue1
dc.citation.volume19
dc.contributor.authorZülke A
dc.contributor.authorLuck T
dc.contributor.authorPabst A
dc.contributor.authorHoffmann W
dc.contributor.authorThyrian JR
dc.contributor.authorGensichen J
dc.contributor.authorKaduszkiewicz H
dc.contributor.authorKönig H-H
dc.contributor.authorHaefeli WE
dc.contributor.authorCzock D
dc.contributor.authorWiese B
dc.contributor.authorFrese T
dc.contributor.authorRöhr S
dc.contributor.authorRiedel-Heller SG
dc.coverage.spatialEngland
dc.date.accessioned2023-11-22T00:51:29Z
dc.date.accessioned2024-07-25T06:50:12Z
dc.date.available2019-08
dc.date.available2023-11-22T00:51:29Z
dc.date.available2024-07-25T06:50:12Z
dc.date.issued2019-08-01
dc.description.abstractBackground In the absence of treatment options, the WHO emphasizes the identification of effective prevention strategies as a key element to counteract the dementia epidemic. Regarding the complex nature of dementia, trials simultaneously targeting multiple risk factors should be particularly effective for prevention. So far, however, only few such multi-component trials have been launched, but yielding promising results. In Germany, comparable initiatives are lacking, and translation of these complex interventions into routine care was not yet done. Therefore, AgeWell.de will be conducted as the first multi-component prevention trial in Germany which is closely linked to the primary care setting. Methods AgeWell.de will be designed as a multi-centric, cluster-randomized controlled multi-component prevention trial. Participants will be older community-dwelling general practitioner (GP) patients (60–77 years; n = 1,152) with increased dementia risk according to CAIDE (Cardiovascular Risk Factors, Aging, and Incidence of Dementia) Dementia Risk Score. Recruitment will take place at 5 study sites across Germany. GP practices will be randomized to either intervention A (advanced) or B (basic). GPs will be blinded to their respective group assignment, as will be the statistician conducting the randomization. The multi-component intervention (A) includes nutritional counseling, physical activity, cognitive training, optimization of medication, management of vascular risk factors, social activity, and, if necessary, further specific interventions targeting grief and depression. Intervention B includes general health advice on the intervention components and GP treatment as usual. We hypothesize that over the 2-year follow-up period the intervention group A will benefit significantly from the intervention program in terms of preserved cognitive function/delayed cognitive decline (primary outcome), and other relevant (secondary) outcomes (e.g. quality of life, social activities, depressive symptomatology, cost-effectiveness). Discussion AgeWell.de will be the first multi-component trial targeting risk of cognitive decline in older adults in Germany. Compared to previous trials, AgeWell.de covers an even broader set of interventions suggested to be beneficial for the intended outcomes. The findings will add substantial knowledge on modifiable lifestyle factors to prevent or delay cognitive decline. Trial registration German Clinical Trials Register (reference number: DRKS00013555).
dc.format.pagination203-
dc.identifier.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/31370792
dc.identifier.citationZülke A, Luck T, Pabst A, Hoffmann W, Thyrian JR, Gensichen J, Kaduszkiewicz H, König H-H, Haefeli WE, Czock D, Wiese B, Frese T, Röhr S, Riedel-Heller SG. (2019). AgeWell.de - study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients.. BMC Geriatr. 19. 1. (pp. 203-).
dc.identifier.doi10.1186/s12877-019-1212-1
dc.identifier.eissn1471-2318
dc.identifier.elements-typejournal-article
dc.identifier.issn1471-2318
dc.identifier.pii10.1186/s12877-019-1212-1
dc.identifier.urihttps://mro.massey.ac.nz/handle/10179/70978
dc.languageeng
dc.publisherBioMed Central Ltd
dc.relation.isPartOfBMC Geriatr
dc.rights(c) 2019 The Author/s
dc.rightsCC BY 4.0
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectCluster-randomized controlled trial
dc.subjectCognition
dc.subjectDementia
dc.subjectLate life
dc.subjectLifestyle
dc.subjectMental health
dc.subjectMulti-component intervention
dc.subjectPrevention
dc.subjectPrimary care
dc.subjectAged
dc.subjectAging
dc.subjectBehavior Therapy
dc.subjectCognitive Dysfunction
dc.subjectExercise
dc.subjectFemale
dc.subjectGermany
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectPrimary Health Care
dc.subjectQuality of Life
dc.subjectRisk Reduction Behavior
dc.titleAgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients
dc.typeJournal article
pubs.elements-id455023
pubs.organisational-groupOther
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