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AgeWell.de - a multi-centric cluster-randomized controlled prevention trial in primary care

AgeWell.de - a multi-centric cluster-randomized controlled prevention trial in primary care - AgeWell.de

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013555
Enrollment
1152
Registered
2017-12-07
Start date
2018-07-11
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive decline in elderly GP patients with increased dementia risk

Interventions

Group 1: Intervention group: Multi-component intervention program over two years including nutritional counseling, physical activity, cognitive training, optimization of medication, management of vasc

Sponsors

Universität Leipzig, Medizinische Fakultät, Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 77 Years

Inclusion criteria

Inclusion criteria: GP patients living in the community, who have an increased dementia risk (increased CAIDE Dementia Risk Score)

Exclusion criteria

Exclusion criteria: dementia; severe loss of vision, hearing, or communicative ability; insufficient ability to speak and read German; disorders preventing cooperation as judged by the GP; concurrent participation in another intervention trial; disorders affecting safe engagement in the intervention

Design outcomes

Primary

MeasureTime frame
Change in cognitive performance measured as change in a composite cognitive z score based on the results from tests of a cognitive test battery (Trail Making Test A and B; CERAD neuropsychological test battery subtests Word List, Verbal Fluency Test Animals and Constructional Praxis; Reading the Mind in the Eyes Test Revised Version). Cognitive performance will be assessed at baseline and at follow-up after 2 years

Secondary

MeasureTime frame
(i) Mortality (assessed at follow-up after 2 years or before, if there is evidence on possible mortality; information will be obtained from relatives, the attending GP or from the local registry offices using a standardized questionnaire); (ii) Nursing home Placement (assessed at follow-up after 2 years using a standardized questionnaire); (iii) Functioning in everyday activities (assessed at baseline and follow-up after 2 years using the Barthel-Index and the Amsterdam IADL Questionnaire); (iv) Quality of life (assessed at baseline and follow-up after 2 years using the WHOQOL); (v) Depressive symptoms (assessed at baseline and follow-up after 2 years using the Geriatric Depression Scale); (vi) Social inclusion (assessed at baseline and follow-up after 2 years using the Lubben Social Network Scale and standardized questions on social activities); (vii) Cost-effectiveness (assessed at baseline and follow-up after 2 years using the standardized Questionnaire for Health-Related Resource Use and the EQ-5D index for calculation of Quality-Adjusted Life Years/QALYs)

Countries

Germany

Contacts

Public ContactAndrea Zülke

Universität Leipzig, Medizinische Fakultät, Institut für Sozialmedizin, Arbeitsmedizin und Public Health (ISAP)

andrea.zuelke@medizin.uni-leipzig.de+49 341 9715483

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026