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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Spain1 site
  • Germans Trias i Pujol Hospital

    Badalona, Catalonia, 08916

Other trials in Spain

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.

  1. First, data will be collected to analyze the incidence of delirium in the unit prior to the intervention (baseline data/usual care).
  2. 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.
  3. 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.
  4. Implementation of the multicomponent care plan specific to the prevention of delirium. (Annex 3).
  5. The impact of training on clinical outcomes in the intervention unit will be analyzed.
  6. 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.

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 groups in NCT07119385
Study groupRoleWhat they receive
No intervention (usual medical care)OtherThe usual care will be provided according to the center's protocols.
Receives: Other: Usual care
Intervention (PREDELENF Multicomponent Intervention)ExperimentalA 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.

  1. 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)
  1. Sociodemographic Variables

    Gender, age, and place of origin (home, nursing home)

    Measured: Baseline

  2. 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

  3. 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

  4. 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.

  1. First posted13 Aug 2025
  2. Study start26 Oct 2023
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

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)
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 17949569
  • Cano 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 25378001
  • Restrepo 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 30017037
  • Witlox 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 20664045
  • Bellelli 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 33994990
  • Leslie 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 18195192
  • Inouye 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 23992774
  • Carrasco 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 23282695
  • Formiga 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 17988613
  • Pão-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

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.

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