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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical changes in delirium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Computer-based cognitive intervention
Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet.
Intervention: Specific computer-based cognitive stimulation intervention (Behavioral)
Computer-based cognitive intervention
Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet.
Intervention: Usual care intervention (Behavioral)
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.
Intervention: Usual care intervention (Behavioral)
Outcomes
Primary Outcomes
Clinical changes in delirium
Time Frame: Baseline and one week after enrollment
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.
The presence and severity of delirium and its core symptoms
Time Frame: Baseline and one week after enrollment
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.
Presence of delirium according DSM-5 criteria
Time Frame: One week after enrollment
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.
Secondary Outcomes
- 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)
- Adherence to and follow-up of non-pharmacological measures(From admission to the first week)