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Table 2 Overview of assessments conducted for all participants

From: A digitally supported multimodal lifestyle program to promote brain health among older adults (the LETHE randomized controlled feasibility trial): study design, progress, and first results

 

Screening

Baseline

Month 6

Month 12

Month 24

General participant characteristics

 Demographics (age, sex), education, marital & socioeconomic status, living situation

x

x

  

x

Self-reported health status & medical history

 Medical history, diagnoses, medication use

 

x

x

x

x

 Family history of dementia, CVD, diabetes

 

x

 

x

x

Measurements

 Height & weight (BMI), blood pressure, hip-waist circumference

x

x

x

x

x

 Routine blood testsa

 

x

x

x

x

 DNA sample (for APOE genotyping)

 

x

   

 Blood samples for research purposesb

 

x

  

x

 Brain MRI

 

x

  

x

Cognition & function

 CERAD word list learning & delayed recall

x

    

 MMSE

x

  

x

x

 Subjective cognitive concerns

 

x

x

x

x

 CDR, CDR-SB

 

x

  

x

 Extended NTB

 

x

 

x

x

 Digital cognitive assessment battery (cCOG)c

 

x

 

x

x

 IADL

 

x

 

x

x

Physical performance

 SPPB, grip strength, timed 10-m dual task test

 

x

  

x

Lifestyle questionnairesd

 Food and eating habits

 

x

 

x

x

 Physical activity

 

x

 

x

x

 Smoking & alcohol consumption

 

x

 

x

x

 Cognitive & social activities

 

x

 

x

x

 Sleep problems (ISI)

 

x

 

x

x

Mood, depressive symptoms, quality of lifed

 Stress-related symptoms (PSS-14)

 

x

 

x

x

 Depressive symptoms (CES-D)

 

x

 

x

x

 Zung depression scalee

 

x

   

 Health-related quality of life (RAND-36)

 

x

 

x

x

Health literacy, attitudes & experiencesd

 Health literacy (HLS-EU-Q16)

 

x

  

x

 Attitudes to dementia prevention and risk reduction (selected items of MCLHB-DRR scale)

 

x

  

x

 Digital skills, Internet use, smartphone habits

 

x

   

 Assessment of experiences with the LETHE App (SUS)

 

x

x

 

x

 Reasons for participation

 

x

   

 Feedback on participation

   

x

x

Passive data collection through the smartwatch, smartphone & LETHE App

 Activity log, sleep parameters, heart rate, heart rate variability, step count, SpO2 (smartwatch)

Continuous data collection throughout the trial

 Phone sensor & app data (count of nearby Bluetooth devices, phone usage data, data on LETHE App usage)

 Data from the cTRAIN cognitive training program (e.g., logins, performance)f

  1. aTotal cholesterol, HDL, LDL, triglycerides, HbA1c, CRP, fasting glucose, creatinine, ASAT, ALAT, GGT
  2. bAnalysis of aging- and dementia-related biomarkers e.g., AD markers (p-tau181, NfL)
  3. cUsing personal computer/tablet or a device at the study center, approx. 1 month after each NTB
  4. dQuestionnaires completed independently in the LETHE App
  5. eAssessed in Austria, Finland, and Italy
  6. fOnly intervention group
  7. Abbreviations: ADL activities of daily living, APOE apolipoprotein E, ALAT alanine aminotransferase, ASAT aspartate aminotransferase, BMI body mass index, CDR Clinical Dementia Rating, CDR-SB Clinical Dementia Rating Sum of Boxes, CERAD Consortium to Establish a Registry for Alzheimer's Disease, CES-D Center for Epidemiologic Studies Depression Scale, CRP C-reactive protein, CVD cardiovascular disease, GGT gamma-glutamyl transferase, HDL high-density lipoprotein, HLS-EU-Q16 16-item European Health Literacy Survey Questionnaire, IADL Instrumental Activities of Daily Living, ISI Insomnia Severity Index, LDL low-density lipoprotein, MCLHB-DRR The Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction scale (Kim et al., Dementia and Geriatric Cognitive Disorders Extra, 2014), MMSE Mini-Mental State Examination, MRI magnetic resonance imaging, NfL neurofilament light chain, NTB Neuropsychological Test Battery, PSS-14 14-item Perceived Stress Scale, p-tau181 phosphorylated tau 181, SPPB Short Physical Performance Battery, SUS 10-item System Usability Scale
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Alzheimer's Research & Therapy

ISSN: 1758-9193