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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Esteban Sepulveda-Ramos, PhD
- 전화번호: +34-977338565
- 이메일: esteban.sepulveda@urv.cat
연구 장소
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Tarragona
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Reus, Tarragona, 스페인, 43206
- 모병
- Institut Pere Mata
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연락하다:
- Esteban Sepulveda-Ramos, PhD
- 전화번호: +34-669900887
- 이메일: esteban.sepulveda@urv.cat
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Computer-based cognitive intervention
Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet.
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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:
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활성 비교기: 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.
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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:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Clinical changes in delirium
기간: Baseline and one week after enrollment
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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.
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Baseline and one week after enrollment
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The presence and severity of delirium and its core symptoms
기간: Baseline and one week after enrollment
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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.
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Baseline and one week after enrollment
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Presence of delirium according DSM-5 criteria
기간: One week after enrollment
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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.
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One week after enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Psychopharmacological treatment during the first week
기간: From enrollment to the end of the intervention in one week
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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.
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From enrollment to the end of the intervention in one week
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Changes in functional independence in activities of daily living
기간: Upon enrollment and one week later
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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.
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Upon enrollment and one week later
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Change in fall risk
기간: Upon enrollment and one week later
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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).
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Upon enrollment and one week later
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Change in ability to walk unassisted
기간: Upon enrollment and one week later
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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.
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Upon enrollment and one week later
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Relevant clinical events
기간: From admission to the first week
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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.
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From admission to the first week
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Adherence to and follow-up of non-pharmacological measures
기간: From admission to the first week
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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.
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From admission to the first week
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Delitract
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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섬망 상태에 대한 임상 시험
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Bozok University모병수술 후 합병증 | 소아 환자 | 수술 전 불안 (Ameliyat Öncesi Anksiyete) | Emergence Delirium (Derlenme Deliryumu)터키 (Türkiye)