AgeWell.de (Germany)

AgeWell.de

The AgeWell.de trial is the first multi-component trial targeting risk of cognitive decline in older adults in Germany. Results show that the intervention reduced dementia risk according to LIBRA scores (LIfestyle for BRAin health), with beneficial effects primarily referable to changes in diet and blood pressure. The intervention improved health-related quality of life in men and women, and reduced depressive symptoms in women. The results support the need of more intensive and better individually targeted lifestyle interventions for older adults.

Aims of the project

To evaluate the effectiveness of a multi-component intervention in preventing or delaying cognitive decline in older adults at increased risk for dementia, specifically tailored to the German health care context.
To assess effects of the multi-component intervention regarding (i) mortality, (ii) nursing home placement, (iii) functioning in everyday activities, (iv) quality of life, (v) depressive symptoms, (vi) social inclusion, and (vii) the cost-effectiveness of the intervention

Location

Multiple centers
Recruiting centers: Leipzig, Greifswald, Kiel, Munich, Halle
Expertise centers (no recruitment): Hannover (data management), Hamburg (health economics), Heidelberg (pharmacology)

Local setting

Challenges
The COVID-19 pandemic imposed severe challenges on intervention conduct and extended the duration between baseline and 24-month follow-up interview for a substantial proportion of participants.

Leading organization

University of Leipzig

Principal Investigator (PI)

Steffi G. Riedel-Heller, Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig

Research team

Andrea Zülke, Alexander Pabst, Melanie Luppa, Steffi G. Riedel-Heller, Institute of Social Medicine, Occupational Health and Public Health (ISAP), Medical Faculty, University of Leipzig, Germany

Wolfgang Hoffmann, Jochen René Thyrian, German Centre for Neurodegenerative Diseases (DZNE), Greifswald, Germany

Hanna Kaduszkiewicz, Institute of General Practice, University of Kiel, Germany

Jochen Gensichen, Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Germany

Thomas Frese, Institute of General Practice and Family Medicine, Martin-Luther-University Halle-Wittenberg, Halle, Saale, Germany

Birgitt Wiese, MHH Information Technology – Science & Laboratory, Hannover Medical School, Germany

Hans-Helmut König, Department of Health Economics and Health Service Research, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

David Czock, Internal Medicine IX – Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Germany

Duration of the intervention

24 months

Project start date

2018

Project end date

2022

Current stage of the project

Completed

Number of study participants

819

Target population

Community-dwelling patients from General Practice (primary care), 60-77 years of age and at-risk of dementia (based on CAIDE Dementia Risk Score)

Primary outcome

Change in cognitive performance assessed with a neuropsychological test battery (Trail Making Test A and B, CERAD Wordlist Memory, Verbal Fluency Test “Animals”, CERAD Constructional Practice, Reading the Mind in the Eyes test (revised version)).

Secondary outcomes

Mortality
Nursing home placement
Instrumental activities of daily living (IADL)
Quality of life
Depressive symptoms
Social inclusion
Motivation for behavior change
Cost-effectiveness

Exploratory outcomes

Dementia risk profiles (Lifestyle for Brain Health (LIBRA)-score)
Neuroimaging markers of neurodegeneration and small vessel disease (MRI sub-study at Leipzig study centre)

Intervention

Domains

Nutritional counselling (based on guidelines of the German Nutrition Society)
Physical activity enhancement
Cognitive training: utilized “NeuroNation” software
Optimization of medication
Management of vascular risk factors
Enhancement of social engagement
Intervention for bereavement, grief and depressive symptoms

Motivation tasks across all components.

Results

Primary outcome

No intervention effect on the global cognitive performance of individuals in the intervention group.
Intervention effect on dementia risk profiles, assessed using the Lifestyle for Brain Health (LIBRA)-score

Secondary outcomes

The intervention improved health-related quality of life in the intervention group.
Reduced depressive symptoms in women in the intervention group.
Perceived restrictions in intervention conduct by the COVID-19 pandemic did not impact intervention effectiveness.

Exploratory outcomes

No intervention effects on neuroimaging markers of neurodegeneration and small vessel disease

Acknowledgements

This study is funded by the German Federal Ministry for Education and Research (BMBF; reference numbers: 01GL1704A, 01GL1704B, 01GL1704C, 01GL1704D, 01GL1704E, 01GL1704F).