An interventional study of Specific computer-based cognitive stimulation intervention and Usual care intervention in Delirium, sponsored by Institut Investigacio Sanitaria Pere Virgili. Recruiting at 1 site in Spain. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Institut Investigacio Sanitaria Pere Virgili · Not applicable, Interventional, and Treatment
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:
After one week, the presence and severity of delirium will be reassessed.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 60 is below the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 39 studies on the registry; 18 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: One week after enrollment
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From admission to the first week
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be made available on request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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