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Recruiting NCT07563244

Computer-assisted Cognitive Stimulation Treatment for Delirium

No phase Interventional Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Specific computer-based cognitive stimulation intervention, Usual care intervention.
Who it may be relevant to
Registry conditions: Delirium. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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.

Overview

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.

Interventions

  • 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 cog
  • 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 tre

Primary outcome measures

  • Clinical changes in delirium [Time frame: Baseline and one week after enrollment]
  • The presence and severity of delirium and its core symptoms [Time frame: Baseline and one week after enrollment]
  • Presence of delirium according DSM-5 criteria [Time frame: One week after enrollment]
Secondary outcome measures (6)
  • Psychopharmacological treatment during the first week [Time frame: From enrollment to the end of the intervention in one week]
  • Changes in functional independence in activities of daily living [Time frame: Upon enrollment and one week later]
  • Change in fall risk [Time frame: Upon enrollment and one week later]
  • Change in ability to walk unassisted [Time frame: Upon enrollment and one week later]
  • Relevant clinical events [Time frame: From admission to the first week]
  • Adherence to and follow-up of non-pharmacological measures [Time frame: From admission to the first week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Institut Pere Mata — Reus

Identifiers

NCT: NCT07563244 · Delitract

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗