Background
Relevance
Objectives
Methods
Study design
Inclusion and exclusion criteria
Interventions
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advice on healthy nutrition, based on the guidelines of the German Nutrition Society (DGE)
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exercises for strength, balance and flexibility on two days per week; aerobic training (3–5 days per week for 20–30 min) planned individually with the participant
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cognitive training with tablet computers, using the cognitive training software “NeuroNation”, three times per week
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enhancement of social engagement, planned individually with the participant
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if necessary, feedback on vascular risk factors (e.g. smoking, medical history) and ways to reduce the respective risk
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assessment of depressive symptoms and underlying risk factors (e.g. bereavement, grief); if necessary, patients will be encouraged to contact their GP who will provide adequate support and care (e.g. referring participants to groups, psychiatrists, psychotherapists, psychiatric hospitals); written information on addresses and helplines which can be contacted in case of grief and/or depressive symptoms.
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optimization of medication: see Table 1 for a detailed description.
Intervention Component | Description |
---|---|
Nutritional counseling | - Based on the guidelines of the German Nutrition Society [33] including recommendations e.g. on intake of cereal products, fruit and vegetables, fish, sugar, salt, and of fluid. - Anthropometric measurements (height, weight, BMI) |
Physical activity enhancement | - Combined training program including (i) muscle-strengthening activity, (ii) flexibility activity/balance exercise, on 2 days/week, and (iii) aerobic activity (3–5 days a week for 20–30 min). Strength and flexibility/balance training can be conducted at home. Aerobic training will be planned with each participant individually - Participants will receive a pedometer to record the number of steps walked daily |
Cognitive training | - Information on cognitive functioning and the impact of cognitive activity/training on cognitive performance and dementia risk; information on strategies to train cognition in everyday life - Cognitive training at home on a regular basis (3 times/week, 15 min per session) with tablet computers (software: NeuroNation; https://www.neuronation.com/) |
Optimization of medication | - Collection of baseline information (i) from the GP on participants’ medication, diagnoses, and lab values (creatinine, hemoglobin A1c) and (ii) from the participants on their actual medication - Electronically supported data evaluation to identify potentially inappropriate medication (e.g. anticholinergics, using a list based on Gray and coworkers [13], potentially missing drugs (using START criteria A1 to A8; [34]), contraindicated drug combinations, and contraindications in patients with renal impairment (using databases from the electronic drug information system AiDKlinik). Discrepancies in the information on medication collected from the participant and the GP will be identified. - Reports including recommendations on the medication of a participant will be transmitted to the GP. For recommended drugs, this will include information on potentially serious drug-drug interactions and on drug dose adjustment in patients with renal impairment. A procedure is established in case of emergencies, e.g. if an important drug for a serious condition is not administered by the patient. If a patient reports difficulties with drug administration (difficulties swallowing tablets or capsules, tablet splitting, subcutaneous injections, use of inhalers, transdermal patch application, or with the administration of eye drops, nose drops, ear drops, or rectal or vaginal drug administration), specific information is provided to the patient. |
Management of vascular risk factors | - Assessment of medication and diagnoses, lab values, health parameters, lifestyle factors, blood pressure and anthropometric measurements (height, weight) - Information on further vascular risk factors (e.g. smoking, medical history) - Feedback on vascular risk, importance of reducing the risk, and possible ways of achieving such a reduction - Nutritional counseling, recommendation of weight loss (if necessary), physical activity enhancement, and optimization of medication as described above |
Enhancement of social engagement | - Assessment of level of social activity and risk of social isolation - Information on the importance of an active lifestyle including high social engagement for dementia risk - Enhancement of social engagement will be planned together with each study participant individually |
Bereavement, grief and depressive symptoms | - Assessment of depressive symptoms and underlying risk factors (e.g. bereavement, grief) - If necessary, participants will be encouraged to contact their GP and will be provided with adequate support and care (e.g. referring participants to groups, psychiatrists, psychotherapists, psychiatric hospitals). Additionally, participants will receive written information on addresses and helplines which can be contacted in case of grief and/or depressive symptoms. - If applicable, encouragement to use MoodGym – a scientifically developed and evaluated free web-based training program to prevent and reduce depressive symptoms (http://www.moodgym-deutschland.de/). |
Motivational tasks across all components | - Personnel continuity regarding the contact person for the participants - Study nurses will be trained in motivational interviewing techniques and participants will be strongly encouraged to contact their contact person, whenever necessary - Birthday/Christmas/holiday cards originally signed by trial authorities/principal investigators - Participants of intervention A will receive a brochure including recommendations (additional tips and suggestions each week for an active lifestyle, e.g. recipes, suggestions for physical activity, and information on healthy ageing) as well as a weekly diary to track their activities in the intervention components. |
Outcomes
Primary endpoint
Secondary endpoints
Measures of cognitive performance (primary endpoint)
| |
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Construct | Instrument |
Cognitive performance
a
| • Trail Making Test A and B [35] • 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
| |
Depressive symptoms
a
| |
Social inclusion
| Lubben Social Network Scale (LSNS; [52] in combination with standardized questionnaire on social activity [self-constructed itemsc] |
Cost effectiveness
| |
Motivation for behavior change
| |
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
| |
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] |