Table 2 Instruments used in AgeWell.de
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 | |
Quality of life | EQ-5D and visual analogue scale (EQ VAS scale) [47]; WHOQOL-Bref [48], WHOQOL-Old [49] |
Depressive symptoms a | |
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] | |