GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia. (GOIZ_ZAINDU)

Fundacion CITA-alzheimer

Status: Completed

Conditions: Dementia Risk Factors; Multidomain Intervention; Prevention; Cognitive Decline

Treatments: Behavioral: Multidomain intervention (MD-Int) group

Study type: Interventional

Funder types: Other

Identifiers

NCT06163716

GZ trial

Details and patient eligibility

About

GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and collecting data to design a large efficacy trial.

Full description

The GOIZ ZAINDU pilot trial is a one-year controlled, randomized, multidomain intervention trial, for prevention of cognitive decline, carried out in the municipality of Beasain in the Basque Country (Spain). Participants were recruited in collaboration with the primary care center health providers from Beasain Municipality after an informative prevention campaign on lifestyle and dementia.

After the baseline evaluation, all participants received in person verbal information on the potential benefits of caring for vascular risk factors, adhering to Mediterranean diet, and having good cognitive and physical activity routines. Participants were later randomly assigned to a standard health advice control group (RHA, control) or the multidomain intervention group (MD-Int). Random assignment followed a proportion of 1:1 and was stratified by age (<75 years vs.≥75 years), sex, and cognitive status (normal cognition vs. MCI).

1. Regular health advice control (RHA) group. Participants randomized to the control group followed preventive programs already ongoing at their Primary Care Unit regarding physical activity, socialization, and smoking and alcohol usage. Visits to the GP and nurse depended on personal demands and necessities; nevertheless, annual consultation was recommended for all patients over 60 years old.
2. Multidomain intervention (MD-Int) group. The MD-Int program was designed to provide tools and routines that participants could incorporate into daily living activities and reinforce the social environment. Although the program included standardized guidelines and exercises, each participant was considered individually, adapting nutritional requirements and physical and cognitive activity according to individual needs and abilities. This methodology is based on the FINGER trial design[23] but has been adapted to local resources and the healthcare system. GPs and nurses were involved in the follow-up visits. Most intervention activities were carried out at the local Primary Care Centre. Local town hall resources such as group activities for older adults at the municipality sports centre and current outdoor sports activities were incorporated in the study. The MD-Int program included: 1) individual follow-up visits every three months for cardiovascular risk factor monitoring and nutritional counselling with primary health care providers; 2) two nutritional workshops led by a nutritionist; 3) 20 hours of cognitive stimulation delivered through group sessions and 4) 40 hours of individual cognitive training exercises. Participants in the MD-Int group received recommendations to practice 2 to 6 hours of physical exercise per week and get involved in sports activities. Social stimulation was promoted through group activities.

Enrollment: 125 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants were at least 60 years of age,
• had a CAIDE score ≥ 6 points and
• performed below than expected in at least one of two brief cognitive tests - Memory alteration test (T@M) and Fototest
• or scored two or higher in the AD8 informant's questionnaire of cognitive symptoms.

Exclusion criteria

• Exclusion criteria included the presence of poorly controlled cardiovascular or respiratory disease,
• previous diagnosis of dementia, ongoing neurological disorders, unstable psychiatric disease, evidence of any other severe disease of any etiology,
• or any situation, in the investigator's opinion, that could compromise safe engagement in the intervention.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups

Regular health advice control (RHA) group.

No Intervention group

Description:

Participants randomized to the control group followed preventive programs already ongoing at their Primary Care Unit regarding physical activity, socialization, and smoking and alcohol usage. Visits to the GP and nurse depended on personal demands and necessities; nevertheless, annual consultation was recommended for all patients over 60 years old.

Multidomain intervention (MD-Int) group

Experimental group

Description:

The MD-Int program was designed to provide tools and routines that participants could incorporate into daily living activities and reinforce the social environment. Although the program included standardized guidelines and exercises, each participant was considered individually, adapting nutritional requirements and physical and cognitive activity according to individual needs and abilities. This methodology is based on the FINGER trial design but has been adapted to local resources and the healthcare system. GPs and nurses were involved in the follow-up visits. Most intervention activities were carried out at the local Primary Care Centre. Local town hall resources such as group activities for older adults at the municipality sports centre and current outdoor sports activities were incorporated in the study.

Treatment:

Behavioral: Multidomain intervention (MD-Int) group