Computer-assisted Cognitive Stimulation Treatment for Delirium

NCT07563244 | Recruiting

• 1 other identifier: Delitract
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of our study are to determine whether people with delirium in a subacute care unit improve after one week with non-pharmacological therapies based on improving sleep schedules, mobility, and cognitive stimulation (such as memory, attention, orientation, among others), and to compare two groups of people who will receive slightly different therapies. We will try to determine whether individual characteristics (such as diagnosed diseases, blood test results or genetics, gender, age, educational level, among others) influence the onset of an episode of delirium, its severity and its response to treatment. Participants with delirium will be divided into two groups that will receive:

• The non-pharmacological treatment described
• One group will also receive a specific cognitive intervention from an occupational therapist, using a computer programme on a tablet, twice a day for one week. After one week, the presence and severity of delirium will be reassessed.

Conditions

Delirium

Keywords

Delirium; Older adults; Dementia; Subacute care; Cognitive training

Outcome Measures

Primary Outcomes (3)

• Clinical changes in delirium

  The overall severity of delirium and of each of its symptoms will be assessed using the Delirium Rating Scale-Revised-98 (DRS-98) by psychiatrists at the time of admission and after one week, in order to determine changes in its clinical manifestations. The DRS-98 includes phenomenological descriptors to assess the severity levels of each of its 16 items (ranging from 0 to 3, indicating from absence to maximum severity). Scores on the total scale range from 0 to 46 points (items 1 to 16) and from 0 to 39 points on the severity scale (items 1 to 13), indicating from the absence to the maximum severity of symptoms.

  Baseline and one week after enrollment

• The presence and severity of delirium and its core symptoms

  The presence and severity of global delirium and of three of its symptoms corresponding to its core domains, assessed using the Delirium Diagnostic Tool-Provisional (DTT-Pro) administered by general practitioners at the time of admission and one week later, in order to determine changes in clinical manifestations. Each item is scored on a Likert scale ranging from zero (maximum severity) to three (no abnormality), with nine being the highest possible score and zero the lowest possible score. The recommended cut-off score is ≤6 for delirium and ≤7 to also identify patients with subsyndromic delirium.

  Baseline and one week after enrollment

• Presence of delirium according DSM-5 criteria

  Psychiatrists will assess for the presence of delirium according to the DSM-5 criteria at the time of admission and one week later, in order to determine whether the diagnosis still applies after one week.

  One week after enrollment

Secondary Outcomes (6)

• Psychopharmacological treatment during the first week

  From enrollment to the end of the intervention in one week

• Changes in functional independence in activities of daily living

  Upon enrollment and one week later

• Change in fall risk

  Upon enrollment and one week later

• Change in ability to walk unassisted

  Upon enrollment and one week later

• Relevant clinical events

  From admission to the first week

Study Arms (2)

Computer-based cognitive intervention

EXPERIMENTAL

Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet.

Behavioral: Specific computer-based cognitive stimulation intervention; Behavioral: Usual care intervention

Usual care intervention

ACTIVE COMPARATOR

Participants will receive the usual non-pharmacological measures, with emphasis on three groups: guidance, cognitive stimulation and visuospatial measures, early active mobility, and recovery of the sleep-wake cycle.

Behavioral: Usual care intervention

Interventions

Specific computer-based cognitive stimulation intervention BEHAVIORAL

Specific cognitive stimulation intervention using a tablet, administered by the occupational therapist, with the aim of carrying out two interventions each day: one in the morning and one in the afternoon. Each intervention will vary in duration, depending on the person's clinical condition, but will not exceed 20 minutes. Each person will receive the intervention for a period of one week from the diagnosis of delirium, corresponding to five working days. The intervention will focus on three cognitive aspects that are part of the core symptoms of delirium: attention, orientation and visuospatial ability.

Computer-based cognitive intervention

Usual care intervention BEHAVIORAL

Participants will undergo a comprehensive geriatric assessment and will be prescribed multidisciplinary treatment according to the clinical criteria of the centre's professionals, in order to address the underlying condition for which the patient has been admitted to the centre and any associated comorbidities. The guidelines for pharmacological and non-pharmacological treatment of delirium included in the centre's clinical guidelines will be followed. With regard to the non-pharmacological treatment of delirium, specific measures will be taken for: 1. Orientation and cognitive stimulation, including visuospatial measures. 2. Early active mobility. 3. Restoration of the sleep-wake cycle.

Computer-based cognitive intervention; Usual care intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 60 years or over who are admitted to the subacute care center between 15 February and 15 October 2026 and who sign the informed consent (the patient and their family or legal guardians if the patient's cognitive condition prevents them from giving consent themselves)

You may not qualify if:

• Patients who, at the time of admission, meet the criteria for palliative end-of-life care.
• Individuals under 60 years of age, to ensure sample homogeneity and reduce confounding factors.
• Individuals with severe visual or hearing impairment or aphasia, due to the difficulty of carrying out the cognitive intervention.
• Serious communication difficulties due to language.

Sponsors & Collaborators

• Institut Pere Mata: collaborator
• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Institut Pere Mata

Reus, Tarragona, 43206, Spain

RECRUITING

MeSH Terms

Conditions

Delirium; Dementia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Esteban Sepulveda-Ramos, PhD

CONTACT

+34-977338565; esteban.sepulveda@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: May 1, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): February 16, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)