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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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Tarragona
      • Reus, Tarragona, Spanien, 43206
        • Rekrytering
        • Institut Pere Mata
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Computer-based cognitive intervention
Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet.
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.
Aktiv komparator: 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.

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical changes in delirium
Tidsram: 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.
Baseline and one week after enrollment
The presence and severity of delirium and its core symptoms
Tidsram: 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.
Baseline and one week after enrollment
Presence of delirium according DSM-5 criteria
Tidsram: 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.
One week after enrollment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Psychopharmacological treatment during the first week
Tidsram: 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.
From enrollment to the end of the intervention in one week
Changes in functional independence in activities of daily living
Tidsram: 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.
Upon enrollment and one week later
Change in fall risk
Tidsram: 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).
Upon enrollment and one week later
Change in ability to walk unassisted
Tidsram: 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.
Upon enrollment and one week later
Relevant clinical events
Tidsram: 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.
From admission to the first week
Adherence to and follow-up of non-pharmacological measures
Tidsram: 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.
From admission to the first week

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 februari 2026

Primärt slutförande (Beräknad)

16 oktober 2026

Avslutad studie (Beräknad)

16 februari 2027

Studieregistreringsdatum

Först inskickad

5 mars 2026

Först inskickad som uppfyllde QC-kriterierna

24 april 2026

Första postat (Faktisk)

1 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 april 2026

Senast verifierad

1 februari 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Data will be made available on request.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

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