DeliriumDelitractNCT07563244
Computer-assisted Cognitive Stimulation Treatment for Delirium
A study testing Specific computer-based cognitive stimulation intervention in people with Delirium, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Specific computer-based cognitive stimulation intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2026to 16 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Institut Pere Mata
Reus, Tarragona, 43206
Esteban Sepulveda-Ramos, PhD, +34-669900887, esteban.sepulveda@urv.cat
About this study
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.
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.
Read more
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.
- Conditions
- Delirium
- Being tested
- Specific computer-based cognitive stimulation intervention, Usual care intervention
- Keywords
- Delirium, Older adults, Dementia, Subacute care, Cognitive training
- Medical subject headings
- Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific computer-based cognitive stimulation interventionBehavioural
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.
Usual care interventionBehavioural
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:
- Orientation and cognitive stimulation, including visuospatial measures.
- Early active mobility.
- Restoration of the sleep-wake cycle.
| Study group | Role | What they receive |
|---|---|---|
| Computer-based cognitive intervention | Experimental | Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet. Receives: Behavioral: Specific computer-based cognitive stimulation intervention; Behavioral: Usual care intervention |
| Usual care intervention | Active comparator | 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. Receives: Behavioral: Usual care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One week after enrollment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission to the first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start16 Feb 2026
- Primary completion16 Oct 2026 (estimated)
- Study completion16 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pere Mata
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563244
- Sponsor's protocol ID
- Delitract
- Acronym
- Delitract
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available on request.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07563244
- Acronym / sponsor ID
- Delitract / Delitract
- Conditions
- Delirium
- Keywords
- Delirium, Older adults, Dementia, Subacute care, Cognitive training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Institut Pere Mata
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Oct 2026 (estimated)
- Study completion
- 16 Feb 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-based cognitive intervention | Experimental | Behavioral: Specific computer-based cognitive stimulation intervention, Behavioral: Usual care interventionParticipants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet. |
| Usual care intervention | Active comparator | Behavioral: Usual care interventionParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific computer-based cognitive stimulation interventionSpecific 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. | Behavioural | Computer-based cognitive intervention |
| Usual care interventionParticipants 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. | Behavioural | Computer-based cognitive intervention, Usual care intervention |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Data will be made available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific computer-based cognitive stimulation intervention in people with Delirium, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esteban Sepulveda-Ramos, PhD (+34-977338565, esteban.sepulveda@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical changes in delirium (time frame: Baseline and one week after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.