Psychosocial Intervention for Behavioral Symptoms in Hospitalized Patients With Dementia or Delirium

Summary

Behavioral and psychological symptoms are common among older adults hospitalized with dementia or delirium and may include agitation, wandering, delusions, hallucinations, aggression, oppositional behavior, and sleep disturbances. These symptoms can increase the risk of falls, prolonged hospitalization, functional decline, institutionalization, and caregiver burden. Pharmacological treatment and physical restraint may be ineffective or may worsen clinical outcomes, while evidence on non-pharmacological interventions in acute hospital settings remains limited.

The ESSECOA study is a single-center, randomized, controlled, open-label trial conducted in the Geriatric Unit of the Azienda Ospedaliero-Universitaria di Modena. It evaluates whether adding a structured psychosocial intervention to standard pharmacological management is more effective than standard pharmacological management alone in reducing behavioral disturbances in hospitalized patients aged over 65 years with dementia and/or delirium.

Eligible participants are randomized to one of two parallel groups. The control group receives pharmacological management according to clinical guidelines and best practice. The intervention group receives the same pharmacological management plus sensory and general stimulation sessions three times per week, lasting approximately 40 minutes each. The intervention is individualized according to the patient's history, preferences, target symptoms, and residual abilities. Caregivers are involved during the stimulation sessions and receive two structured educational interventions, one during hospitalization and one before discharge, aimed at improving communication and management strategies that can also be used at home.

The primary objective is to compare the change in behavioral symptoms between groups using the Neuropsychiatric Inventory (NPI). Secondary objectives are to identify which behavioral symptoms respond best to the non-pharmacological approach, particularly in relation to caregiver education. Additional assessments include delirium, cognitive and functional status, depression, comorbidity, antipsychotic medication use, length of hospital stay, discharge destination, healthcare use, mortality, caregiver burden, perceived competence, and perceived needs.

Conditions

• BPSD (Behavioral and Psycological Symptoms of Dementia)

Interventions

BEHAVIORAL

Sensory and General Stimulation With Caregiver Education

Participants receive individualized sensory and general stimulation administered by trained geriatric unit staff three times per week during hospitalization, with each session lasting approximately 40 minutes. Activities are tailored to the participant's personal history, preferences, target behavioral symptoms, and residual abilities. They may include multisensory stimulation in a Snoezelen environment and simple meaningful activities involving the senses. Caregivers participate in the stimulation sessions and receive two structured educational sessions, one during hospitalization and one before discharge, focused on communication and individualized strategies for managing behavioral symptoms at home.

OTHER

Standard Pharmacological Management

Behavioral symptoms are managed according to applicable clinical guidelines and, where specific guidelines are unavailable, according to best clinical practice. Treatment is individualized by the treating physician according to the participant's target symptoms, clinical condition, and comorbidities. The protocol does not mandate a specific study drug, dose, or fixed treatment regimen. Caregivers receive routine information regarding the participant's clinical condition and plan of care.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2026-08-06

Completion

2026-08-30

Countries

• Italy

Study Locations