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

Abstract

Background 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 ).

Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline

“…Case findings were then conducted by the GP or other practice personnel in association with the AgeWell.de-study personnel or independently if desired. For details regarding the recruitment process, please see [ 13 ].…”

“…It was hypothesized that the multi-component intervention program would be superior to GPTAU and GHA regarding trial outcomes. As detailed information on the intervention is less relevant for this report, we would like to point to the study protocol for a comprehensive description of the intervention [ 13 ].…”

Do self‐reported hearing and visual impairments predict longitudinal dementia in older adults?

“…Nonetheless, prevention efforts for dementia should focus on the benefits of healthcare solutions available for HI. In particular, multicomponent interventions targeting modifiable risk and protective factors of dementia should include treatment of HI 37 . At the global public health level, prevention efforts should target particularly low‐ and middle‐income countries, which have the highest burden of HI and dementia 1,36 …”

Demenzprävention und hausärztliche Versorgung: Schätzung der Zielpopulation

“…Das Ziel dieser Studie ist die Ermittlung der möglichen Zielpopulation für demenzpräventive Ansätze sowie der Häufigkeit der GU in den einzelnen Hausarztpraxen (HA). In den zitierten RCTs zur Demenzprävention [8,9,29] werden Screening-Instrumente mit einem bestimmten Cut-Off-Wert verwendet, um eine Zielpopulation für die Intervention zu bestimmen (z.B. bei AgeWell der CAIDE-Score, ein kardiovaskulärer Risikoscore [29]).…”

“…In den zitierten RCTs zur Demenzprävention [8,9,29] werden Screening-Instrumente mit einem bestimmten Cut-Off-Wert verwendet, um eine Zielpopulation für die Intervention zu bestimmen (z.B. bei AgeWell der CAIDE-Score, ein kardiovaskulärer Risikoscore [29]). Ein derartiges an standardisierten Screening-Instrumenten orientiertes Verfahren konnte bei der Betrachtung der hier zur Verfügung stehenden Routinedaten nicht gewählt werden.…”