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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06248723
• Lead Sponsor: University of Milano Bicocca

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-27
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-05
• Last Update Submitted: 2024-02-05
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08
• Study Start: 2024-03
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1340

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active intervention arm	Oral hygiene	* 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.
Active intervention arm	Socializing	* 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.
Active intervention arm	Sleep quality	* 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.
Active intervention arm	Nutritional intervention	* 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.
Active intervention arm	Control of cardiovascular, metabolic, and infectious risk factors	* 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.
Active intervention arm	Pharmacological evaluation	* 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.
Active intervention arm	Physical exercise	* 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.
Active intervention arm	Cognitive training	* 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.
Self-administered intervention arm	Self-administered interventions	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.

Primary Outcome Measures

Name	Time	Method
Modified Neuropsychological Test Battery (mNTB) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6 follow up, Month 12 follow up, and Month 18 follow up. The tests take around 90 minutes overall.	Participants will be scored through the mNTB to assess their cognitive state at baseline and cognitive changes at follow-ups. The mNTB score is a composite score for a battery of 14 tests total. The outcome measure is a z-score, it has no minimum or maximum value. A higher score means a better outcome.

Secondary Outcome Measures

Name	Time	Method
Instrumental Activities of Daily Living (IADL) scale score	The score will be taken at Day 0 Screening visit, at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum score: 0, maximum score: 8, a higher score means a better performance.
14-item Resilience Scale (RS-14) score	The score will be taken at baseline, at Month 6, Month 12, and Month 18 follow-ups.	Minimum score: 14, maximum score: 98, a higher score means a better outcome.
Pittsburgh Sleep Quality Index (PSQI) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 21, a higher score means a worse outcome.
Number of incidental diagnoses of Mild Cognitive Impairment (MCI) and dementia, according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria	Through study completion, an average of 2 years.	A higher number means a worse outcome.
Short Physical Performance Battery (SPPB) score	The score will be taken at Day 0 Screening visit, at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum score: 0, maximum score: 12, a higher score means a better performance.
4-m gait speed test - speed	The test will be repeated at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Walking speed (in meters per second). A higher speed means a better performance.
Number of falls taken	Through study completion, an average of 2 years.	A higher number of falls means a worse outcome.
Psychological General Well Being Index (PGWBI) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 110, a higher score indicates a worse outcome.
Framingham Risk Score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Measured in percentage %, 0-100%. A higher percentage indicates a higher cardiovascular risk (worse outcome).
Cognitive Reserve Index questionnaire (CRIq) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	z-score without a maximum or minimum value, a higher z-score means a better outcome.
Composite memory score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	z-score without a maximum or minimum value, a higher z-score means a better outcome.
World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Health Satisfaction	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 1, maximum: 5, a higher score means a better outcome.
Mini Nutritional Assessment-Short Form (MNA-SF) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 14, a higher score means a better outcome.
Composite score of executive functions	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	z-score without a maximum or minimum value, a higher z-score means a better outcome.
World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Physical Health	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 100, a higher score means a better outcome.
4-m gait speed test - time	The test will be repeated at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Time needed to walk 4 meters (in seconds). A higher time means a worse performance.
Number of visits to general practitioner	Through study completion, an average of 2 years.	The number does not indicate a better or worse outcome. It is only informative.
Geriatric Depression Scale (GDS) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 15, a higher score indicates a worse outcome.
UCLA Loneliness Scale (UCLA-LS) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 20, maximum: 80, a higher score indicates a worse outcome.
World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Psychological Health	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 100, a higher score means a better outcome.
World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Environment	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 100, a higher score means a better outcome.
World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Quality of Life	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 1, maximum: 5, a higher score means a better outcome.
Composite score of processing speed and attention	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	z-score without a maximum or minimum value, a higher z-score means a better outcome.
Hand grip test	The test will be repeated at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Hand grip strength measured (in kilograms) with a hand dynamometer. A higher result means a better performance.
Activities of Daily Living (ADL) index score	The score will be taken at Day 0 Screening visit, at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups..	Minimum score: 0, maximum score: 6, a higher score means a better performance.
Barthel Index score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum score: 0, maximum score: 100, a higher score means a better performance.
Number of hospital admissions	Through study completion, an average of 2 years.	A higher number of hospital admissions means a worse outcome.
World Health Organization Quality Of Life Questionnaire - Brief (WHO-QOL-Brief) score - Social Relationships	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 100, a higher score means a better outcome.
Mediterranean Diet Scale (MDScale) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 0, maximum: 9, a higher score means a better outcome.
Intrinsic Motivation Inventory (IMI) score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	Minimum: 45, maximum: 315, a higher score means a better outcome.
Composite language score	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	z-score without a maximum or minimum value, a higher z-score means a better outcome.
Composite score of general cognitive assessment	The score will be taken at Baseline visit (Day 0 of second phase, which should be indicatively within 30 days of Screening visit), at Month 6, Month 12, and Month 18 follow-ups.	z-score without a maximum or minimum value, a higher z-score means a better outcome.

Trial Locations

Locations (1)

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Italy