Delirium in Old AgePREDELENFNCT07119385
Non-pharmacological Measures for the Prevention of Delirium in Frail Hospitalized Adults. Nursing Care (PREDELENF)
A study testing Multicomponent non-pharmacological interventions in people with Delirium in Old Age, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
Background: Delirium is one of the most frequent, relevant, and increasing geriatric syndromes in hospitalized older adults. It is an indicator of poor prognosis, and its incidence increases with aging. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Multicomponent non-pharmacological interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients >70 years old
- Conscious mental state. And one of the two criteria described below:
- Pfeiffer score on admission between 3-7 errors, according to the nursing assessment within the first 24 hours of admission to the ward, suggesting possible mild-moderate cognitive impairment.
- Any degree of diagnosed dementia, except GDS7.
Who cannot join
- Patients unable to communicate, with established aphasia, or with psychiatric illness.
- Patients with a language barrier.
- Patients transferred from other units.
- Terminal situation under palliative treatment.
- Patients who do not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quasi-experimental Pre-post Study Assessing the Impact of Non-pharmacological Interventions Based on Nursing Care and of an Educational Programme for Delirium Prevention in Older Adults With Cognitive Frailty During Hospitalization
Background: Delirium is one of the most frequent, relevant, and increasing geriatric syndromes in hospitalized older adults. It is an indicator of poor prognosis, and its incidence increases with aging. It is a highly prevalent problem (between 10-56% of hospitalized elderly), underdiagnosed (32-66% undetected), with severe consequences and potentially preventable (between 30-40%). It is considered a priority health objective, as it is an indicator of elderly patient safety and an indicator of healthcare quality.
Objective: The objective of this study is to analyze whether a multicomponent nursing-led intervention reduces the incidence of delirium in frail older patients hospitalized in a medical unit.
Read more
Design: Pre-post quasi-experimental analytical study. Study setting: The study will be conducted in a polyvalent hospitalization unit at the Germans Trias i Pujol University Hospital during the 2023-2025 period.
Patients: A total of 158 patients will be needed, i.e., 79 for each group. Sampling: Consecutive intentional sampling based on inclusion and exclusion criteria.
Variables: Sociodemographic variables, delirium risk factors, daily presence of delirium using the CAM scale, and hospital stay duration, among others, will be collected.
Procedure: Patients will be selected upon admission, and the presence of delirium will be assessed daily using the CAM scale, with results recorded. Nursing staff will be trained on non-pharmacological measures for delirium prevention and a specific care plan. Subsequently, the second group of patients will receive these specific interventions, and the presence of delirium will be assessed daily using the CAM scale, with results recorded.
Data analysis: Descriptive and inferential analysis using the PSPP statistical package version 22. A significance level of 5% will be applied.
Read the detailed description
A pre-post quasi-experimental study will be conducted with a control group and an intervention group. Consecutive sampling will be performed purposively, using inclusion and exclusion criteria. A total of 158 patients are required, i.e., 79 per group. Granmo software was used to calculate the sample. An alpha risk of 0.05 was assumed, with a two-sided contrast and a beta risk of 0.2. The allocation ratio will be 1, and a 10% loss to follow-up rate and a 20% reduction in the incidence of delirium have been estimated.
Participants Patients over 70 years of age admitted to the HGTIP study units for conditions requiring hospitalization and who meet the established criteria. The inclusion and exclusion criteria for selecting participants for this study are shown in Table 1.
Recruitment of participants Candidates for the study will be identified daily by a member of the research team, who will check the computerized devices used to detect new admissions to the study unit. Those who meet the inclusion criteria will be invited to participate. The study will be explained to them, including their family members. If they agree, they will be provided with an informed consent form, which they will sign.
All patients admitted to the study unit who meet the established criteria will be included in the sample, until the required sample size is reached, estimated at approximately six months for the control group and another six months for the intervention group.
Intervention The study will be conducted in the multipurpose hospitalization unit of the Germans Trias i Pujol University Hospital (HUGTIP) during the period 2024-2025.
- First, data will be collected to analyze the incidence of delirium in the unit prior to the intervention (baseline data/usual care).
- The work to be performed will be communicated to the nursing and medical specialty teams of the multipurpose hospitalization unit and will be presented as an intervention to improve the quality of care.
- A 1-hour in-person training program will be provided for each work shift (morning, afternoon, evening 1, and evening 2) to all professionals in the intervention unit.
- Implementation of the multicomponent care plan specific to the prevention of delirium. (Annex 3).
- The impact of training on clinical outcomes in the intervention unit will be analyzed.
- Finally, the incidence of delirium will be analyzed, along with the specific care plan and training for professionals in preventing the syndrome.
Elements of the investigation A multicomponent care plan has been designed, comprising 12 intervention areas based on the main risk factors for delirium. For each area, different activities are proposed, as shown in Table 2. The intervention also includes a series of structural and scheduling modifications in the study unit, as specified in Table 3.
Furthermore, the training program that will be provided to all professionals in the intervention unit is based on strategies recommended by the Spanish Society of Geriatrics and Gerontology (SEGG) for the prevention of delirium.
The training will include the definition of delirium, symptoms of delirium that will help us recognize it early, its presentation (hyperactivity, hypoactivity, and mixed forms), training in the detection of delirium using the CAM scale, possible causes, predisposing and precipitating factors, the evolution of delirium once it has developed, prevention strategies, non-pharmacological measures, and the use of medications.
Implementation of the intervention The control group's data collection period will last approximately six months, or until the required sample size is reached. The unit's professionals will then be informed about the work to be performed, and their knowledge of the topic will be analyzed through a survey. The training program will then be delivered, and the care plan, along with any structural and scheduling modifications, will be implemented. Participants will be asked to complete the knowledge survey again to evaluate the training's impact. Finally, data will be collected from the intervention group for approximately another six months, or until the full sample size is reached.
Data collection Data collection will be conducted by the same professional from the research team within the first 24 to 48 hours of admission, based on medical records, nursing records, and information obtained directly from the patient and support staff.
Upon admission, sociodemographic data will be collected (age, sex, origin: home, intermediate care, residence, admission diagnosis and global status (Charlson, Pfeiffer, Barthel, Rockwood/CFS, PCC, ECA and presence of geriatric syndromes such as dysphagia, incontinence, falls, and other factors predisposing to delirium such as cognitive impairment, depression, pain, sensory disturbances, nutritional status, dehydration, delirium in previous admissions, psychoactive medication).
Daily data collection during admission includes the following variables: presence of delirium using the CAM scale, follow-up, correction of sensory disturbances, cognitive stimulation, mobilization, hydration and nutrition, psychoactive medications, and nighttime rest.
The variables to be collected for discharge are: days of admission, presence of delirium, days of duration of delirium, Pfeiffer, Barthel, destination: home, intermediate care, residence, psychoactive medication.
- Conditions
- Delirium in Old Age
- Being tested
- Multicomponent non-pharmacological interventions, Usual care
- Keywords
- Prevention, Delirium, Frailty, Multicomponent intervention
- Medical subject headings
- Delirium, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent non-pharmacological interventionsOther
Multicomponent non-pharmacological interventions to prevent delirium in frail patients
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| No intervention (usual medical care) | Other | The usual care will be provided according to the center's protocols. Receives: Other: Usual care |
| Intervention (PREDELENF Multicomponent Intervention) | Experimental | A multicomponent intervention designed for the prevention of delirium in frail patients.Include different actions (see variables) Receives: Other: Multicomponent non-pharmacological interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Delirium
Assessment of the presence of delirium will be performed by trained personnel using the Confusion Assessment Method (CAM). The CAM consists of four items, and a positive CAM (indicating the presence of delirium) is defined as the presence of both of the first two items (1 and 2) and at least one of the last two items (3 or 4).
Measured: From baseline (day 1) until day 12 (expected date of hospital discharge or death from any cause)
Secondary outcomes (4)
Sociodemographic Variables
Gender, age, and place of origin (home, nursing home)
Measured: Baseline
Current illness/geriatric assessment upon admission. Assess cognition using the Pfeiffer Questionnaire
The Pfeiffer Questionnaire is a screening tool used to detect cognitive impairment. It consists of 10 items, and a score of three or more may indicate cognitive impairment. Higher scores are associated with a greater likelihood of cognitive decline
Measured: Baseline
Current illness/geriatric assessment upon admission. Diagnosis of Dementia
Review the patient's medical record for a diagnosis of dementia prior to admission
Measured: Baseline
Current illness/geriatric assessment upon admission. Degree of frailty
The Rockwood Clinical Frailty Scale (CFS) is a scoring tool that assesses frailty using a 9-point scale. The higher the score, the greater the patient's level of frailty.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start26 Oct 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miriam Moreno, RN,MSC,PhDc, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119385
- Sponsor's protocol ID
- PI-23-105
- Acronym
- PREDELENF
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tobar E, Alvarez E. Delirium en el adulto mayor hospitalizado. RMCLC. 2020;
Chavez-Delgado ME, Virgen-Enciso M, Perez-Guzman J, Celis-de-la-Rosa A, Castro-Castaneda S. [Detection of delirium in hospitalized elderly patients using the confusion assessment method]. Rev Med Inst Mex Seguro Soc. 2007 Jul-Aug;45(4):321-8. Spanish.
PubMed 17949569Cano G. Contribuciones al estudio de factores de riesgo y mortalidad del delirium y fragilidad en adultos mayores hospitalizados. Bilbao. 2022.
Fernandez Mª, Faus M. Medidas no farmacológicas para la prevención del delirium en pacientes ingresados en Unidades de Cuidados Intensivos. THERAPEÍA. 2021;14: 113-40.
Gonzalez B, Marín JM, Gutierrez V, Velilla N. Protocolo diagnóstico y manejo del delirium en el anciano. Protocolos. 2018;12(62): 3670-4.
Carrasco G M, Villarroel D L, Calderon P J, Martinez F G, Andrade A M, Gonzalez T M. [Development and validation of a clinical predictive model for delirium in hospitalized older people]. Rev Med Chil. 2014 Jul;142(7):826-32. doi: 10.4067/S0034-98872014000700002. Spanish.
PubMed 25378001Restrepo D, Duque M, Montoya L, Berrouet MC, Rojas M, Lopera G, Giraldo K. Risk Factors and Hospital Mortality in Surgical and Non-surgical Patients with Delirium. Rev Colomb Psiquiatr (Engl Ed). 2018 Jul-Sep;47(3):148-154. doi: 10.1016/j.rcp.2017.03.001. Epub 2017 Apr 21. English, Spanish.
PubMed 30017037Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
PubMed 20664045Bellelli G, Brathwaite JS, Mazzola P. Delirium: A Marker of Vulnerability in Older People. Front Aging Neurosci. 2021 Apr 30;13:626127. doi: 10.3389/fnagi.2021.626127. eCollection 2021.
PubMed 33994990Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-year health care costs associated with delirium in the elderly population. Arch Intern Med. 2008 Jan 14;168(1):27-32. doi: 10.1001/archinternmed.2007.4.
PubMed 18195192Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774Carrasco M, Accatino-Scagliotti L, Calderon J, Villarroel L, Marin PP, Gonzalez M. [Delirium in older medical inpatients: a one year follow up study]. Rev Med Chil. 2012 Jul;140(7):847-52. doi: 10.4067/S0034-98872012000700003. Spanish.
PubMed 23282695Formiga F, San Jose A, Lopez-Soto A, Ruiz D, Urrutia A, Duaso E. [Prevalence of delirium in patients admitted because of medical conditions]. Med Clin (Barc). 2007 Oct 27;129(15):571-3. doi: 10.1157/13111707. Spanish.
PubMed 17988613Pão-Mole M, Dourado RM, Pontífice P. Delirium: intervenciones de enfermería en el adulto hospitalizado - una revisión bibliográfica. Enferm glob. 2018;17(52): 640-88.
Perello Campaner C. [Delirium risk assessment in elderly hospitalized patients]. Rev Esp Geriatr Gerontol. 2010 Sep-Oct;45(5):285-90. doi: 10.1016/j.regg.2010.03.011. Epub 2010 Aug 8. Spanish.
PubMed 20696498
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quasi-experimental Pre-post Study Assessing the Impact of Non-pharmacological Interventions Based on Nursing Care and of an Educational Programme for Delirium Prevention in Older Adults With Cognitive Frailty During Hospitalization
- ClinicalTrials.gov ID
- NCT07119385
- Acronym / sponsor ID
- PREDELENF / PI-23-105
- Conditions
- Delirium in Old Age
- Keywords
- Prevention, Delirium, Frailty, Multicomponent intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Aug 2025 (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.
Background: Delirium is one of the most frequent, relevant, and increasing geriatric syndromes in hospitalized older adults. It is an indicator of poor prognosis, and its incidence increases with aging. It is a highly prevalent problem (between 10-56% of hospitalized elderly), underdiagnosed (32-66% undetected), with severe consequences and potentially preventable (between 30-40%). It is considered a priority health objective, as it is an indicator of elderly patient safety and an indicator of healthcare quality.
Objective: The objective of this study is to analyze whether a multicomponent nursing-led intervention reduces the incidence of delirium in frail older patients hospitalized in a medical unit.
Design: Pre-post quasi-experimental analytical study. Study setting: The study will be conducted in a polyvalent hospitalization unit at the Germans Trias i Pujol University Hospital during the 2023-2025 period.
Patients: A total of 158 patients will be needed, i.e., 79 for each group. Sampling: Consecutive intentional sampling based on inclusion and exclusion criteria.
Variables: Sociodemographic variables, delirium risk factors, daily presence of delirium using the CAM scale, and hospital stay duration, among others, will be collected.
Procedure: Patients will be selected upon admission, and the presence of delirium will be assessed daily using the CAM scale, with results recorded. Nursing staff will be trained on non-pharmacological measures for delirium prevention and a specific care plan. Subsequently, the second group of patients will receive these specific interventions, and the presence of delirium will be assessed daily using the CAM scale, with results recorded.
Data analysis: Descriptive and inferential analysis using the PSPP statistical package version 22. A significance level of 5% will be applied.
Detailed description
A pre-post quasi-experimental study will be conducted with a control group and an intervention group. Consecutive sampling will be performed purposively, using inclusion and exclusion criteria. A total of 158 patients are required, i.e., 79 per group. Granmo software was used to calculate the sample. An alpha risk of 0.05 was assumed, with a two-sided contrast and a beta risk of 0.2. The allocation ratio will be 1, and a 10% loss to follow-up rate and a 20% reduction in the incidence of delirium have been estimated.
Participants Patients over 70 years of age admitted to the HGTIP study units for conditions requiring hospitalization and who meet the established criteria. The inclusion and exclusion criteria for selecting participants for this study are shown in Table 1.
Recruitment of participants Candidates for the study will be identified daily by a member of the research team, who will check the computerized devices used to detect new admissions to the study unit. Those who meet the inclusion criteria will be invited to participate. The study will be explained to them, including their family members. If they agree, they will be provided with an informed consent form, which they will sign.
All patients admitted to the study unit who meet the established criteria will be included in the sample, until the required sample size is reached, estimated at approximately six months for the control group and another six months for the intervention group.
Intervention The study will be conducted in the multipurpose hospitalization unit of the Germans Trias i Pujol University Hospital (HUGTIP) during the period 2024-2025.
- First, data will be collected to analyze the incidence of delirium in the unit prior to the intervention (baseline data/usual care).
- The work to be performed will be communicated to the nursing and medical specialty teams of the multipurpose hospitalization unit and will be presented as an intervention to improve the quality of care.
- A 1-hour in-person training program will be provided for each work shift (morning, afternoon, evening 1, and evening 2) to all professionals in the intervention unit.
- Implementation of the multicomponent care plan specific to the prevention of delirium. (Annex 3).
- The impact of training on clinical outcomes in the intervention unit will be analyzed.
- Finally, the incidence of delirium will be analyzed, along with the specific care plan and training for professionals in preventing the syndrome.
Elements of the investigation A multicomponent care plan has been designed, comprising 12 intervention areas based on the main risk factors for delirium. For each area, different activities are proposed, as shown in Table 2. The intervention also includes a series of structural and scheduling modifications in the study unit, as specified in Table 3.
Furthermore, the training program that will be provided to all professionals in the intervention unit is based on strategies recommended by the Spanish Society of Geriatrics and Gerontology (SEGG) for the prevention of delirium.
The training will include the definition of delirium, symptoms of delirium that will help us recognize it early, its presentation (hyperactivity, hypoactivity, and mixed forms), training in the detection of delirium using the CAM scale, possible causes, predisposing and precipitating factors, the evolution of delirium once it has developed, prevention strategies, non-pharmacological measures, and the use of medications.
Implementation of the intervention The control group's data collection period will last approximately six months, or until the required sample size is reached. The unit's professionals will then be informed about the work to be performed, and their knowledge of the topic will be analyzed through a survey. The training program will then be delivered, and the care plan, along with any structural and scheduling modifications, will be implemented. Participants will be asked to complete the knowledge survey again to evaluate the training's impact. Finally, data will be collected from the intervention group for approximately another six months, or until the full sample size is reached.
Data collection Data collection will be conducted by the same professional from the research team within the first 24 to 48 hours of admission, based on medical records, nursing records, and information obtained directly from the patient and support staff.
Upon admission, sociodemographic data will be collected (age, sex, origin: home, intermediate care, residence, admission diagnosis and global status (Charlson, Pfeiffer, Barthel, Rockwood/CFS, PCC, ECA and presence of geriatric syndromes such as dysphagia, incontinence, falls, and other factors predisposing to delirium such as cognitive impairment, depression, pain, sensory disturbances, nutritional status, dehydration, delirium in previous admissions, psychoactive medication).
Daily data collection during admission includes the following variables: presence of delirium using the CAM scale, follow-up, correction of sensory disturbances, cognitive stimulation, mobilization, hydration and nutrition, psychoactive medications, and nighttime rest.
The variables to be collected for discharge are: days of admission, presence of delirium, days of duration of delirium, Pfeiffer, Barthel, destination: home, intermediate care, residence, psychoactive medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention (usual medical care) | Other | Other: Usual careThe usual care will be provided according to the center's protocols. |
| Intervention (PREDELENF Multicomponent Intervention) | Experimental | Other: Multicomponent non-pharmacological interventionsA multicomponent intervention designed for the prevention of delirium in frail patients.Include different actions (see variables) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients >70 years old
- Conscious mental state. And one of the two criteria described below:
- Pfeiffer score on admission between 3-7 errors, according to the nursing assessment within the first 24 hours of admission to the ward, suggesting possible mild-moderate cognitive impairment.
- Any degree of diagnosed dementia, except GDS7.
Key exclusion criteria (5 listed)
- Patients unable to communicate, with established aphasia, or with psychiatric illness.
- Patients with a language barrier.
- Patients transferred from other units.
- Terminal situation under palliative treatment.
- Patients who do not consent to participate
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 |
|---|---|---|
| Multicomponent non-pharmacological interventionsMulticomponent non-pharmacological interventions to prevent delirium in frail patients | Other | Intervention (PREDELENF Multicomponent Intervention) |
| Usual careUsual care | Other | No intervention (usual medical care) |
Primary outcome
Presence of Delirium
Time frame: From baseline (day 1) until day 12 (expected date of hospital discharge or death from any cause)
Assessment of the presence of delirium will be performed by trained personnel using the Confusion Assessment Method (CAM). The CAM consists of four items, and a positive CAM (indicating the presence of delirium) is defined as the presence of both of the first two items (1 and 2) and at least one of the last two items (3 or 4).
4 secondary outcomes
Sociodemographic Variables
Time frame: Baseline
Current illness/geriatric assessment upon admission. Assess cognition using the Pfeiffer Questionnaire
Time frame: Baseline
Current illness/geriatric assessment upon admission. Diagnosis of Dementia
Time frame: Baseline
Current illness/geriatric assessment upon admission. Degree of frailty
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- BackgroundTobar E, Alvarez E. Delirium en el adulto mayor hospitalizado. RMCLC. 2020;
- Background: PubMed 17949569Chavez-Delgado ME, Virgen-Enciso M, Perez-Guzman J, Celis-de-la-Rosa A, Castro-Castaneda S. [Detection of delirium in hospitalized elderly patients using the confusion assessment method]. Rev Med Inst Mex Seguro Soc. 2007 Jul-Aug;45(4):321-8. Spanish.
- BackgroundCano G. Contribuciones al estudio de factores de riesgo y mortalidad del delirium y fragilidad en adultos mayores hospitalizados. Bilbao. 2022.
- BackgroundFernandez Mª, Faus M. Medidas no farmacológicas para la prevención del delirium en pacientes ingresados en Unidades de Cuidados Intensivos. THERAPEÍA. 2021;14: 113-40.
- BackgroundGonzalez B, Marín JM, Gutierrez V, Velilla N. Protocolo diagnóstico y manejo del delirium en el anciano. Protocolos. 2018;12(62): 3670-4.
- Background: PubMed 25378001Carrasco G M, Villarroel D L, Calderon P J, Martinez F G, Andrade A M, Gonzalez T M. [Development and validation of a clinical predictive model for delirium in hospitalized older people]. Rev Med Chil. 2014 Jul;142(7):826-32. doi: 10.4067/S0034-98872014000700002. Spanish.
- Background: PubMed 30017037Restrepo D, Duque M, Montoya L, Berrouet MC, Rojas M, Lopera G, Giraldo K. Risk Factors and Hospital Mortality in Surgical and Non-surgical Patients with Delirium. Rev Colomb Psiquiatr (Engl Ed). 2018 Jul-Sep;47(3):148-154. doi: 10.1016/j.rcp.2017.03.001. Epub 2017 Apr 21. English, Spanish.
- Background: PubMed 20664045Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
- Background: PubMed 33994990Bellelli G, Brathwaite JS, Mazzola P. Delirium: A Marker of Vulnerability in Older People. Front Aging Neurosci. 2021 Apr 30;13:626127. doi: 10.3389/fnagi.2021.626127. eCollection 2021.
- Background: PubMed 18195192Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-year health care costs associated with delirium in the elderly population. Arch Intern Med. 2008 Jan 14;168(1):27-32. doi: 10.1001/archinternmed.2007.4.
- Background: PubMed 23992774Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Background: PubMed 23282695Carrasco M, Accatino-Scagliotti L, Calderon J, Villarroel L, Marin PP, Gonzalez M. [Delirium in older medical inpatients: a one year follow up study]. Rev Med Chil. 2012 Jul;140(7):847-52. doi: 10.4067/S0034-98872012000700003. Spanish.
- Individual participant dataSharing planned: No
Related trials for Delirium in Old Age
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Recruiting
Low Pneumoperitoneum Pressure for Delirium Prevention in Elderly Laparoscopy
Postoperative Delirium (POD), Intracranial Hypertension
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
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. This study is not recruiting at the moment.
Miriam Moreno, RN,MSC,PhDc principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent non-pharmacological interventions in people with Delirium in Old Age, run by Germans Trias i Pujol Hospital 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Delirium (time frame: From baseline (day 1) until day 12 (expected date of hospital discharge or death from any cause)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07119385, which also lists 26 linked publications.
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 13 Aug 2025.