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Table 2 Instruments used in AgeWell.de

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

Measures of cognitive performance (primary endpoint)
Construct Instrument
Cognitive performance a • Trail Making Test A and B [35] • Word List Memory - CERAD subtest [36,37,38] • Verbal Fluency Test - Animals - CERAD subtest [37,38,39,40] • Constructional Practice – CERAD subtest [37, 38, 41] • Reading the Mind in the Eyes Test - Revised version [42, 43]b • Montreal Cognitive Assessment (MoCA; [44]).
Instruments to assess secondary endpoints in AgeWell.de
Construct Instrument
Mortality Information obtained from the GP or confidant elected by the participant [self-constructed itemsc]
Nursing home placement Information from the participant or – if the participant is unavailable or dead – from the GP or a contact person elected by the participant
ADL/IADL Barthel Index [45], Amsterdam-IADL scale [46]a
Quality of life EQ-5D and visual analogue scale (EQ VAS scale) [47]; WHOQOL-Bref [48], WHOQOL-Old [49]
Depressive symptoms a Geriatric Depression Scale (GDS; [50, 51])
Social inclusion Lubben Social Network Scale (LSNS; [52] in combination with standardized questionnaire on social activity [self-constructed itemsc]
Cost effectiveness Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA)-Questionnaire for Health-Related Resource Use in an Elderly Population [53]; unit costs for monetary valuation of resource use [54]; EQ-5D [47]
Motivation for behavior change Stage assessment in the adoption and maintenance of physical activity and fruit and vegetable consumption [55,56,57]
Instruments to assess further information relevant for the AgeWell.de-trial
Construct Instrument
Sociodemographic information Standardized questionnaire (age, sex, educational level/professional life/activity, living situation/marital status, socio-economic status)
Subjective cognitive decline a Standardized questionnaire on subjective cognitive decline [58]
Self-reported impairments and symptoms Standardized questionnaire on self-reported impairment in walking, vision, or hearing [self-constructed itemsc] Standardized questionnaire on self-reported anticholinergic symptoms [self-constructed itemsc]
Anthropometry, blood pressure Measurement of height, weight, blood pressure; calculation of body-mass-index (BMI)
Nutrition Standardized questionnaire on food consumption (food frequency questionnaire/FFQ [59])
Physical activity I Standardized questionnaire on physical activity [self-constructed itemsc]
Bereavement, grief Standardized questionnaire on bereavement [60]
Medication I (i) Information from the attending GP on participants’ medication (“GP-list”) and diagnosesb, lab values using GP practice records and (ii) information from participants on their actual medication (“brown-bag review”), adherence, and difficulties with drug administration using standardized questionnaires [self-constructed itemsc]
additional vascular risks Standardized questionnaires on additional vascular risk factors (e.g. smoking, medical history, familial medical history; [self-constructed itemsc])
Instruments to assess further information in intervention group A
Construct Instrument
Physical activity II Weekly records on conduct of the physical activity intervention component, training, and pedometer results [self-constructed itemsc]
Cognitive training Weekly records on conduct of the cognitive training [self-constructed itemsc]
Medication II Standardized feedback questionnaires on potential changes in a participant’s medication or reasons for not following the recommendations, completed by the attending GP [self-constructed itemsc]
Social activity Weekly records on social activity, in addition to the information collected on social inclusion (see above)
Motivation and readiness for change Standardized questionnaire on motivation and readiness for behavior change [55,56,57]
Instruments to conduct the process evaluation
Construct Instrument
Success rate of recruitment and quality of the study population Standardized questionnaires filled out by the GP practice personnel (number of eligible GP patients, number of participants and non-participants, (baseline) characteristics of participants and non-participants, reasons for non-participation) [self-constructed itemsc]
Standardized telephone interview on reasons for leaving the study with intervention A-participants, if applicable [self-constructed itemsc]
Quality of the execution of the intervention, burden for GP patients and GPs Standardized interviews with all intervention A-participants on adherence to the intervention components and potential burdens [self-constructed itemsc]
Standardized GP questionnaires on barriers and facilitators for adherence to intervention components in the GPs’ view and on own potential burdens [self-constructed itemsc]
  1. GP general practitioner, ADL Activities of Daily Living, IADL Instrumental Activities of Daily Living
  2. aInformation should be also used to diagnose DSM-5 Mild and Major Neurocognitive Disorder/dementia
  3. bThe composite cognitive z-score for the primary endpoint change in cognitive performance will be calculated based on the test results regarding these six domains
  4. cQuestionnaires can be obtained from the corresponding author upon request