Computer-assisted Cognitive Stimulation Treatment for Delirium (Delitract)

Clinical, Demographic and Genetic Factors Associated With Response to Computer-assisted Cognitive Stimulation Treatment as Part of Non-pharmacological Care in Patients With Delirium. Feasibility Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium
• Intervention / Treatment: Behavioral: Specific computer-based cognitive stimulation intervention; Behavioral: Usual care intervention

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esteban Sepulveda-Ramos, PhD; Phone Number: +34-977338565; Email: esteban.sepulveda@urv.cat

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43206
      • Recruiting
      • Institut Pere Mata
      • Contact: Esteban Sepulveda-Ramos, PhD; Phone Number: +34-669900887; Email: esteban.sepulveda@urv.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer-based cognitive intervention; 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; 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.; Behavioral: Usual care intervention; 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: Orientation and cognitive stimulation, including visuospatial measures.; Early active mobility.; Restoration of the sleep-wake cycle.
Active Comparator: Usual care intervention; 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; 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: Orientation and cognitive stimulation, including visuospatial measures.; Early active mobility.; Restoration of the sleep-wake cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychopharmacological treatment during the first week	We will record whether the individual has been prescribed any of the following types of medication: antipsychotics, benzodiazepines, anticholinergics, opioids and antidepressants. We will note whether these were prescribed on admission, during the follow-up period or at the end of the follow-up period. We will record the generic name and daily dose of each medication, in accordance with the internationally accepted units of measurement for each medication.	From enrollment to the end of the intervention in one week
Changes in functional independence in activities of daily living	Functional independence in activities of daily living will be assessed on admission and one week later, using the Barthel Index. The Barthel Index uses a rating scale to score performance across 10 aspects, with total scores ranging from 0 to 100. A higher score indicates greater independence.	Upon enrollment and one week later
Change in fall risk	The fall risk will be assessed on admission and one week later using the Tinetti test, which has a minimum score of 0 and a maximum score of 28 (the lower the score, the higher the fall risk).	Upon enrollment and one week later
Change in ability to walk unassisted	The patient's walking ability prior to the acute episode that led to admission will be assessed on admission and again one week later using the Functional Ambulation Category (FAC) scale, where a score of 5 indicates the ability to walk unaided and a score of 0 indicates an inability to walk.	Upon enrollment and one week later
Relevant clinical events	We will record clinical events such as the need for referral to A&E, death, falls, the use of physical restraints, new diagnoses or other significant occurrences. These will be recorded in free text format for subsequent classification.	From admission to the first week
Adherence to and follow-up of non-pharmacological measures	We will assess participants' ability and willingness to adhere to non-pharmacological measures, both specific cognitive ones and general ones. These will be recorded in an open-ended format for subsequent classification.	From admission to the first week

Collaborators and Investigators

• Sponsor: Institut Investigacio Sanitaria Pere Virgili
• Collaborators: Institut Pere Mata

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): February 16, 2027

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dementia; Older adults; Delirium; Cognitive training; Subacute care
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Dementia
• Other Study ID Numbers: Delitract

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available on request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No