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

University of Milano Bicocca

Status: Enrolling

Conditions: Age-related Cognitive Decline

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06248723

IN TeMPO

Details and patient eligibility

About

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.

Full description

The study is multicentric and will include 10 centers. Patients will be enrolled either through their General Practitioners (GPs), which will then refer back to their reference centers, or through the centers themselves.

Patients will undergo a screening visit, which will include a multi-faceted evaluation of cognitive function, physical and functional efficiency, and cardiovascular and cognitive decline risk factors. Procedures to be carried out during the screening visit include:

• Collection of socio-demographic data (age, sex, marital status, cohabitation, level of education, social interactions), clinical details (medical and medication history), and evaluation of inclusion/exclusion criteria
• Assessment of the degree of frailty through the Primary Care Frailty Index (PC-FI)
• Assessment of the presence of increased risk of developing dementia through the Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) score
• Assessment of cognitive performance through the General Practitioner assessment of COGnition (GPCOG)
• Assessment of cognitive performance through the Rey Auditory Verbal Learning Test - immediate
• Assessment of functional status by Short Physical Performance Battery (SPPB) tests
• Nonverbal interference tests
• Assessment of cognitive performance through the Rey Auditory Verbal Learning online version (RAVL-T delayed)
• Collection of self-administered scales for cognitive performance assessment through the Test Your Memory - Italian (TYM-I) scale.

Then, eligible patients will be enrolled for the second, active intervention phase of the study, which will include a baseline visit and 3 follow-up visits, at 6, 12, and 18 months.

During these visits, primary and secondary endpoint outcomes will be collected according to protocol.

Enrollment: 1,340 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

• Presence of increased risk of developing dementia by family history (≥ 1 family member with dementia) and/or at least one modifiable risk factor, with Lifestyle Index ≥2. Lifestyle index evaluation: each "Yes" answer to the following questions = 1 point.

  1. Physical activity less than 2.5 hours per week (defined as physical activity intense enough to lead to sweating and breathlessness)*
  2. Diet: less than 5 servings of fruits and vegetables per day*
  3. Diet: less than 2 servings of fish per week*
  4. Hypertension: diagnosed by a physician or on medication, or Systolic Blood Pressure (SBP)>140 mmHg, or Diastolic Blood Pressure (DBP)>90 mmHg)
  5. Diabetes: type 1 or type 2 diagnosed by a physician, or on medication, or HbA1C ≥7 % in the previous 6 months
  6. Sleep disturbances, depressive symptoms, or mental/physical stress symptoms, for at least 1 month, judged by the physician to be disabling in daily life
  7. BMI ≥ 25 kg/m^2*
  8. Alcohol: > 21 alcohol units/week*. *Based on international and WHO guidelines.

• Informed consent freely given and acquired before the start of the study

Exclusion criteria

• 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
• Any condition that prevents safe involvement in the intervention and/or cooperation in the study. For example, a significant neurological or psychiatric condition, including but not limited to brain tumors (benign or malignant), major psychiatric disorders (e.g. current major depressive disorder, schizophrenia, schizoaffective disorder or bipolar disorder), recent brain hemorrhage (parenchymal or subdural), history of concussive head trauma with persistent or significant neurological outcomes, known morpho-structural abnormalities in the brain, active alcohol/drug abuse, active uncontrolled disease of any major organ system; history within the last six months of any acute disease of a major organ system requiring emergency care or hospitalization, including revascularization procedures; severe renal or hepatic insufficiency; unstable or poorly controlled diabetes mellitus, hypertension, or heart failure; malignant neoplasms within the past 3 years (except basal cell carcinoma or squamous cell carcinoma in situ of the skin or localized prostate adenocarcinoma in male participants); any clinically relevant abnormality in blood parameters; severe loss of vision, smar or communication ability, such as to prevent cooperation.
• Enrollment in other trials
• High performance on screening memory tests: RAVL-T immediate score >48 (score ranges 0-75), RAVL-T delayed >10 (score ranges 0-15)
• Planned transfers from the municipality of residence during the duration of the study for a duration longer than 2 weeks.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,340 participants in 2 patient groups

Active intervention arm

Experimental group

Description:

* Physical exercise regime * Mediterranean diet-based nutritional plan * Cognitive training * Regular medical check-ups * Oral hygiene treatments and counseling * Counseling on sleep hygiene and treatment * Control of cardiovascular, metabolic, and infectious risk factors * Adjustment of drug therapy * Suggestions for improving social interactions Physical exercise and cognitive training interventions will be monitored and partially administered through wearable devices and digital tools. Sleep quality will be monitored through wearable devices. Social interactions will be encouraged through a validated app.

Treatment:

Other: Cognitive training

Other: Physical exercise

Other: Nutritional intervention

Other: Sleep quality

Other: Pharmacological evaluation

Other: Oral hygiene

Behavioral: Socializing

Other: Control of cardiovascular, metabolic, and infectious risk factors

Self-administered intervention arm

Active Comparator group

Description:

Subjects in the control group will receive regular health advice in the same domains as the intervention group, via dedicated app and/or access to the dedicated portal on the Age-It website. In addition, participants randomized to the self-guided intervention will receive an initial 30-60 minute counseling session on all domains covered by the study, in which guidelines for healthy diet, physical and cognitive activity, benefits of social activity, information on cardiovascular risk factors, as well as sleep, oral hygiene will be explained. Subjects will therefore be treated as per normal clinical practice, albeit with the help of dedicated apps and counseling session.

Treatment:

Other: Self-administered interventions