Delirium
Conditions
Keywords
Delirium, Older adults, Dementia, Subacute care, Cognitive training
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.
Interventions
BEHAVIORALSpecific 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.
BEHAVIORALUsual 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: 1. Orientation and cognitive stimulation, including visuospatial measures. 2. Early active mobility. 3. Restoration of the sleep-wake cycle.
Sponsors
Institut Investigacio Sanitaria Pere Virgili
Institut Pere Mata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical changes in delirium | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Psychopharmacological treatment during the first week | From enrollment to the end of the intervention in one 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. |
| Changes in functional independence in activities of daily living | Upon enrollment and one week later | 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. |
| Change in fall risk | Upon enrollment and one week later | 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). |
| Change in ability to walk unassisted | Upon enrollment and one week later | 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. |
| Relevant clinical events | From admission to the first week | 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. |
| Adherence to and follow-up of non-pharmacological measures | From admission to the first week | 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. |
Countries
Spain
Contacts
CONTACTEsteban Sepulveda-Ramos, PhD
Outcome results
None listed