Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline (FINGER-NL)

Alzheimercentrum Amsterdam

Status

Active, not recruiting

Conditions

Life Style

Cognitive Decline

Risk Reduction

Treatments

Behavioral: Multidomain lifestyle intervention

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05256199

NL77242.029.21 (Other Identifier)

2021.0220

Details and patient eligibility

About

FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.

Enrollment

1,210 patients

Sex

All

Ages

60 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

60-79 years of age at pre-screening;
Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
Providing informed consent to all study procedures;
Internet access at home;
Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).

Exclusion criteria

Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score<23);
Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
Coincident participation in any other intervention trial at time of pre-screening.
Coincident participation of spouse in FINGER-NL trial.