The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled trial in over 1000 older adults between 60 and 85 years old with increased CAIDE risk score (≥6), non-demented but with low performance in at least one of three brief cognitive tests. Participants will be randomized to receive standard health advice (SHA-control) or a multidomain intervention (MM-Int) consisting of 1) Risk factor control (vascular factors, polypharmacy); 2) Cognitive training, 3) Physical activity, 4) Dietary changing program, and 5) emotional counseling and social engagement. The primary aim is to demonstrate a 20% reduction in the proportion of subjects who decline in their NTB performance (z score) after 24 months in the intervention group compared to the controls. Secondary aims include: 1) Analyze cost-effectiveness; 2) Show a beneficial effect of the intervention on functional abilities, quality of life, and depressive and anxiety symptoms; 3) Investigate the impact of a lifestyle intervention on aging. In this sense, biological samples and neuroimaging studies will be collected to allow exploratory investigations on aging mechanisms, amyloid imbalance, tau pathology, epigenetics, neuroinflammation, vascular dysfunction, lipid dysregulation, white matter disintegration, cognitive and brain reserve. This protocol is participant-centered, empowering citizens since the recruitment process to gain access to knowledge about their dementia risk status via web or by phone and then decide to participate. Intervention activities have also taken into account participants' perspective with the design of easy-to-use and appealing activities (e.g., using a self-administered at-home physical activity program such as VIVIFRAIL© and EXERCITA© cognitive training materials that have been developed, taking into account the Basque Country population's cultural, linguistic and educational particularities; and diet and nutritional workshops with famous chefs to learn innovative and attractive healthy recipes). The GO-ON trial may shed light on the tools that people need to fulfill the expectation of an active, healthy dementia-free aging. These include digital tools that in the COVID19 pandemic have shown to be effective in removing distance barriers. GO-ON uses them to give support and expand the possibilities to clinical assessment settings and intervention delivery. The digital part of the intervention may expand preventive actions to small rural areas, including digital socialization. GO-ON Study, which starts in summer 2021, is the first large-scale lifestyle intervention trial in Southern Europe that takes part in the WORLDWIDE FINGERs network and will help answer whether the FINGER results can be replicated. The intervention design has been made on the basis that if proven to be efficacious, it may be easily applied at a Public System-level to guarantee a rapid and easy translation of research results to Primary Care settings and people homes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,094
1. Cognitive intervention objective: To enhance cognitive functioning and incorporate daily habits and routines that are cognitively stimulating 2. Socio-emotional intervention objective: • Promote socio-emotional skills associated with awareness, communication and regulation of emotions in late life. 3. Nutritional intervention objective: To improve eating habits of participants to be based on the Mediterranean Dietary pattern by an educational program 4. Physical activity intervention objective: To improve aerobic capacity y, decrease the risk of falls, and improve static and dynamic balance. 5. Risk factors and comorbidities monitoring intervention: quarterly scheduled visits for a cardiovascular risk factors check-up and review active medication
CITA-alzheimer
Donostia / San Sebastian, Gipuzkoa, Spain
Global Cognitive performance
Cognitive performance will be assessed with the Neuropsychological Test Battery modified (NTBm) (Harrison J. et aet al.ch Neurol 2007). The NTBm consists of 9 validated components:NTBm Cognitive global, executive function, memory, processing speed scores will be obtained. Composite cognitive z-scores based on the results from all single tests will be calculated. Single z-scores will be calculated using baseline mean and standard deviations of the study sample and, for each composite score, single z-scores will be averaged. Higher scores suggest better performance.
Time frame: up to 2 years
Performance in each cognitive domain
NTBm Cognitive global, executive function, memory, processing speed scores will be obtained. Composite cognitive z-scores based on the results from all single tests will be calculated. Single z-scores will be calculated using baseline mean and standard deviations of the study sample and, for each composite score, single z-scores will be averaged. Higher scores suggest better performance. b. Change in specific cognitive domains will be assessed by the difference in pre-and postintervention scores in episodic memory, executive function and processing speed and visuospatial function z-scores.
Time frame: up to 2 years
Incremental Cost-Utility Ratio (ICUR)
To estimate the cost-effectiveness of the intervention program the Incremental Cost-Utility Ratio (ICUR) between muntidomain intervention group and regular health advice group. The incremental cost-utility ratio (ICUR) will be estimated by dividing incremental cost (Ca-Cb) by incremental utility (Ua-Ub). The time horizon was the patient's lifetime. A 3% discount rate will be applied to costs and effectiveness. Since the main economic impact of dementia is related to the care required as patients become dependent, a societal perspective will be used.
Time frame: up to 2 years
Amsterdam questionnaire for Instrumental Activities of Daily Living (A-IADL-Q)
The Amsterdam IADL Questionnaire (A-IADL-Q) is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in (early) dementia. The questionnaire is completed by a caregiver, such as a relative or friend. (Sikkes SA et al. 2012).
Time frame: up to 2 years
Change in perceived Quality of life - EQ-D-5L scale
The EQ-5D-5L (Herdman M. et al. 2011) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: up to 2 years
Depressive and anxiety sympthoms. Hospital Anxiety and Depression Scale (HADS)
HADS was originally developed by Zigmond and Snaith (1983) and is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen-item scale that generates: Seven of the items relate to anxiety and seven relate to depression.
Time frame: up to 2 years
Change in cognitive performance in different groups of patients with the same APOE status
To assess whether differences between intervention groups concerning the primary and secondary cognitive outcomes vary among subgroups defined by APOE status as a genetic condition.
Time frame: up to 2 years
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