ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Milano Bicocca

About this trial

The goal of this interventional non-pharmacological study is to investigate the effects of a multi-domain intervention ( "active intervention"), compared to that followed by normal clinical practice ("self-guided intervention"), in older adults. The primary objective is whether these interventions can prevent functional and cognitive decline in at-risk subjects.

The multi-domain interventions will include physical exercise, a Mediterranean diet-based nutritional plan, cognitive training, regular medical check-ups, oral hygiene treatments and counseling, monitoring and counseling on visual and auditory abilities, counseling on sleep hygiene and treatment, control of cardiovascular, metabolic, and infectious risk factors, adjustment of drug therapy, suggestions for improving social interactions.

Eligibility criteria

Qualifiers

Aged 60 or older

Mild/moderate vulnerability (Primary Care Frailty Index score between 0.07 and 0.21)

Cardiovascular risk factors, Ageing and Incidence of Dementia (CAIDE) > 6

Clinical Dementia Rating (CDR) ≤ 0.5

Disqualifiers

Diagnosis of dementia or suspected dementia following the screening visit

CDR > 0.5

Residents in residential facilities for the elderly

Inability to consent to informed consent and/or actively participate in study interventions, according to clinical judgment

Trial design

Treatments tested in this trial

  • Nutritional intervention
  • Physical exercise
  • Cognitive training
  • Oral hygiene
  • Sleep quality
  • Control of cardiovascular, metabolic, and infectious risk factors
  • Pharmacological evaluation
  • Socializing
  • Self-administered interventions

Treatment groups

1,340 Participants
are divided into 2 treatment groups

Sponsors and collaborators