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 particular...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-08-01
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| Series: | BMC Geriatrics |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12877-019-1212-1 |
| _version_ | 1818336996824711168 |
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| author | Andrea Zülke Tobias Luck Alexander Pabst Wolfgang Hoffmann Jochen René Thyrian Jochen Gensichen Hanna Kaduszkiewicz Hans-Helmut König Walter E. Haefeli David Czock Birgitt Wiese Thomas Frese Susanne Röhr Steffi G. Riedel-Heller |
| author_facet | Andrea Zülke Tobias Luck Alexander Pabst Wolfgang Hoffmann Jochen René Thyrian Jochen Gensichen Hanna Kaduszkiewicz Hans-Helmut König Walter E. Haefeli David Czock Birgitt Wiese Thomas Frese Susanne Röhr Steffi G. Riedel-Heller |
| author_sort | Andrea Zülke |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-12-13T14:48:12Z |
| format | Article |
| id | doaj.art-87e70ef9de394707bf14538390c02e82 |
| institution | Directory Open Access Journal |
| issn | 1471-2318 |
| language | English |
| last_indexed | 2024-12-13T14:48:12Z |
| publishDate | 2019-08-01 |
| publisher | BMC |
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| series | BMC Geriatrics |
| spelling | doaj.art-87e70ef9de394707bf14538390c02e822022-12-21T23:41:25ZengBMCBMC Geriatrics1471-23182019-08-0119111410.1186/s12877-019-1212-1AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patientsAndrea Zülke0Tobias Luck1Alexander Pabst2Wolfgang Hoffmann3Jochen René Thyrian4Jochen Gensichen5Hanna Kaduszkiewicz6Hans-Helmut König7Walter E. Haefeli8David Czock9Birgitt Wiese10Thomas Frese11Susanne Röhr12Steffi G. Riedel-Heller13Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of LeipzigInstitute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of LeipzigInstitute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of LeipzigInstitute for Community Medicine, University Medicine Greifswald (UMG)German Center for Neurodegenerative Diseases (DZNE)Institute of General Practice/Family Medicine, University Hospital of LMU MunichInstitute of General Practice, University of KielDepartment of Health Economics and Health Service Research, University Medical Center Hamburg-EppendorfDepartment of Clinical Pharmacology and Pharmacoepidemiology, University Hospital HeidelbergDepartment of Clinical Pharmacology and Pharmacoepidemiology, University Hospital HeidelbergInstitute for General Practice, Work Group Medical Statistics and IT-Infrastructure, Hannover Medical SchoolInstitute of General Practice and Family Medicine, Martin-Luther-University Halle-WittenbergInstitute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of LeipzigInstitute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of LeipzigAbstract 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).http://link.springer.com/article/10.1186/s12877-019-1212-1PreventionMulti-component interventionLifestyleCognitionMental healthDementia |
| spellingShingle | Andrea Zülke Tobias Luck Alexander Pabst Wolfgang Hoffmann Jochen René Thyrian Jochen Gensichen Hanna Kaduszkiewicz Hans-Helmut König Walter E. Haefeli David Czock Birgitt Wiese Thomas Frese Susanne Röhr Steffi G. Riedel-Heller AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients BMC Geriatrics Prevention Multi-component intervention Lifestyle Cognition Mental health Dementia |
| title | AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients |
| title_full | AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients |
| title_fullStr | AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients |
| title_full_unstemmed | AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients |
| title_short | AgeWell.de – study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients |
| title_sort | agewell de study protocol of a pragmatic multi center cluster randomized controlled prevention trial against cognitive decline in older primary care patients |
| topic | Prevention Multi-component intervention Lifestyle Cognition Mental health Dementia |
| url | http://link.springer.com/article/10.1186/s12877-019-1212-1 |
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