A Software to Prevent Delirium (PREVEDEL) in Hospitalized Older Adults

NCT05108207 | Unknown DMC

• 1 other identifier: ID16AM2080
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Background Delirium, is a clinical condition characterized by acute and fluctuating deterioration of the cognitive state, generally secondary to an acute pathology. It is a common condition in hospitalized older adults and it develops in 20-30% of patients hospitalized in a general ward and up to 80% of those hospitalized in critical care units. Delirium is associated with negative outcomes in older adults, such as longer hospitalizations, higher mortality, and short and medium-term institutionalization. Randomized clinical trials have shown that delirium is preventable through non-pharmacological prevention measures, decreasing its incidence by 30 to 50%. These interventions include promoting physical activity, facilitating the use of glasses and hearing aids, cognitive stimulation, and providing frequent reorientation of time and space, among others. These measures are currently seldom applied in hospitals in Chile and around the world for various reasons some of which include the heavy workload of clinical staff, the lack of trained personnel, and, in general, the absence of systematic implementation processes. The main objective is to evaluate whether cognitive stimulation guided by PREVEDEL software prevents delirium status(full/subsyncromal delirium) in hospitalized older adults. Method/Design: randomized controlled trial, parallel groups, multicenter. Participants: patients 65 years or older who have been hospitalized for less than 48 hours in the general ward or in the intermediate care unit of 4 hospitals in Santiago, Chile. Intervention: participants in the intervention group will use a tablet with cognitive stimulation software for delirium prevention for 5 continuous days versus the control group who will use the tablet without the software. Evaluations: The incidence of delirium and subsyndromal delirium, duration, density of delirium, cognitive and functional status at discharge, adherence to prevention measures, as well as demographic variables of interest will be evaluated.

Conditions

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations

Keywords

delirium; prevention; cognitive stimulation

Outcome Measures

Primary Outcomes (1)

• Delirium Status (delirium and subsyndromal delirium)

  To evaluate the incidence of delirium and incidence of subsyndromal with Confusion Assessment Method (CAM).

  5 days

Secondary Outcomes (10)

• Duration of delirium

  5 days of protocol and 2 days of follow-up.

• Density of delirium

  5 days.

• Level of independence in basic activities of daily living

  At day 0 and 5.

• Cognitive level

  At day 0 and 5.

• Adherence to prevention measures

  At day 0 and 30 (before and after training in prevention measure).

Study Arms (2)

Control Group

PLACEBO COMPARATOR

will receive the standard delirium prevention measures outlined above, plus the use of a mobile device without delirium prevention software for 5 days (Control Group: nPPD package, without PREVEDEL).

Other: Placebo; Other: Implement a program of non-pharmacological interventions to prevent delirium

Experimental Group

EXPERIMENTAL

will receive the standard delirium prevention measures, plus the use of a mobile device with PREVEDEL software for 5 days (Experimental Group: nPPD package, with PREVEDEL).

Other: Prevention software; Other: Implement a program of non-pharmacological interventions to prevent delirium

Interventions

Prevention software OTHER

The software is installed on an Alcatel OneTouch Pixi-3 10 tablet and is delivered every day to each patient between 9:00 am and 8:00 pm, with nighttime pickup (8:00 pm to 09:00 am), so the patient can rest and to charge the device. The first day, a previously trained health professional delivers the tablet and trains the older adults in its use, taking 10 to 15 minutes. The day after the tablet is delivered, the same person goes to the patient's room to check if he or she has any doubts or problems with its use. Both groups are advised to use the tablet 3 times a day, at least 10 minutes each time.

Experimental Group

Placebo OTHER

All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.

Control Group

Implement a program of non-pharmacological interventions to prevent delirium OTHER

Three months before the start of the clinical trial, an intervention is carried out in the Internal Medicine, Geriatrics and Intermediate Care Unit services of the 4 participating centers in order to establish a homogeneous plan of nPPD and assess adherence. The implementation methodology in the first stage will be according to the Consolidated Framework for Advancing Implementation Science (CFIR) model, used in a local pilot study.

Control Group; Experimental Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients 65 years or older.
• Hospitalized less than an 48 hours ago in a general ward or in the intermediate care unit. Participating health center: 1) Hospital Clínico de la Universidad de Chile, 2) Hospital San Juan de Dios, 3) Clínica Las Condes, 4) Hospital Santiago Oriente Dr Luis Tisné.

You may not qualify if:

• Presence of full or syndromal delirium (CAM+ or presence of one core elements).
• History of dementia (AD8 greater than 2 points).
• Non-Spanish speaking patients.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

University of Chile

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (16)

• 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.

  PMID: 23992774 RESULT

• Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

  PMID: 22762316 RESULT

• Veiga D, Luis C, Parente D, Fernandes V, Botelho M, Santos P, Abelha F. Postoperative delirium in intensive care patients: risk factors and outcome. Rev Bras Anestesiol. 2012 Jul;62(4):469-83. doi: 10.1016/S0034-7094(12)70146-0.

  PMID: 22793963 RESULT

• Leslie DL, Zhang Y, Holford TR, Bogardus ST, Leo-Summers LS, Inouye SK. Premature death associated with delirium at 1-year follow-up. Arch Intern Med. 2005 Jul 25;165(14):1657-62. doi: 10.1001/archinte.165.14.1657.

  PMID: 16043686 RESULT

• Sepulveda E, Leonard M, Franco JG, Adamis D, McCarthy G, Dunne C, Trzepacz PT, Gaviria AM, de Pablo J, Vilella E, Meagher DJ. Subsyndromal delirium compared with delirium, dementia, and subjects without delirium or dementia in elderly general hospital admissions and nursing home residents. Alzheimers Dement (Amst). 2016 Dec 1;7:1-10. doi: 10.1016/j.dadm.2016.11.002. eCollection 2017.

  PMID: 28116342 RESULT

• Meagher D, O'Regan N, Ryan D, Connolly W, Boland E, O'Caoimhe R, Clare J, Mcfarland J, Tighe S, Leonard M, Adamis D, Trzepacz PT, Timmons S. Frequency of delirium and subsyndromal delirium in an adult acute hospital population. Br J Psychiatry. 2014 Dec;205(6):478-85. doi: 10.1192/bjp.bp.113.139865. Epub 2014 Oct 30.

  PMID: 25359923 RESULT

• Abraha I, Trotta F, Rimland JM, Cruz-Jentoft A, Lozano-Montoya I, Soiza RL, Pierini V, Dessi Fulgheri P, Lattanzio F, O'Mahony D, Cherubini A. Efficacy of Non-Pharmacological Interventions to Prevent and Treat Delirium in Older Patients: A Systematic Overview. The SENATOR project ONTOP Series. PLoS One. 2015 Jun 10;10(6):e0123090. doi: 10.1371/journal.pone.0123090. eCollection 2015.

  PMID: 26062023 RESULT

• Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.

  PMID: 10053175 RESULT

• Alvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceno CD, Gonzalez FJ. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial. J Crit Care. 2017 Feb;37:85-90. doi: 10.1016/j.jcrc.2016.09.002. Epub 2016 Sep 10.

  PMID: 27660922 RESULT

• Nydahl P, Dewes M, Dubb R, Hermes C, Kaltwasser A, Krotsetis S, von Haken R. Survey among critical care nurses and physicians about delirium management. Nurs Crit Care. 2018 Jan;23(1):23-29. doi: 10.1111/nicc.12299. Epub 2017 May 18.

  PMID: 28523698 RESULT

• Xing J, Sun Y, Jie Y, Yuan Z, Liu W. Perceptions, attitudes, and current practices regards delirium in China: A survey of 917 critical care nurses and physicians in China. Medicine (Baltimore). 2017 Sep;96(39):e8028. doi: 10.1097/MD.0000000000008028.

  PMID: 28953621 RESULT

• Alvarez EA, Garrido M, Ponce DP, Pizarro G, Cordova AA, Vera F, Ruiz R, Fernandez R, Velasquez JD, Tobar E, Salech F. A software to prevent delirium in hospitalised older adults: development and feasibility assessment. Age Ageing. 2020 Feb 27;49(2):239-245. doi: 10.1093/ageing/afz166.

  PMID: 31957783 RESULT

• Garrido MA, Alvarez EA, Ponce DP, Salech F, Tobar DI, Tobar EA. Consolidated framework for advancing implementation science for the implementation process and adherence assessment of a non-pharmacological delirium prevention program. Int J Geriatr Psychiatry. 2021 Feb;36(2):302-313. doi: 10.1002/gps.5425. Epub 2020 Sep 16.

  PMID: 32892410 RESULT

• Wei LA, Fearing MA, Sternberg EJ, Inouye SK. The Confusion Assessment Method: a systematic review of current usage. J Am Geriatr Soc. 2008 May;56(5):823-30. doi: 10.1111/j.1532-5415.2008.01674.x. Epub 2008 Apr 1.

  PMID: 18384586 RESULT

• Young Y, Fan MY, Hebel JR, Boult C. Concurrent validity of administering the functional independence measure (FIM) instrument by interview. Am J Phys Med Rehabil. 2009 Sep;88(9):766-70. doi: 10.1097/PHM.0b013e3181a9f1d6.

  PMID: 19487922 RESULT

• Garrido M, Alvarez E, Salech F, Rojas V, Jara N, Farias JI, de la Vega DP, Tobar E. Software-guided (PREVEDEL) cognitive stimulation to prevent delirium in hospitalised older adults: study protocol. BMC Geriatr. 2023 Aug 5;23(1):472. doi: 10.1186/s12877-023-04189-2.

  PMID: 37543590 DERIVED

MeSH Terms

Conditions

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Eduardo Tobar Almonacid, MD

CONTACT

+56992368717; etobar@hcuch.cl

Maricel A Garrido Montenegro, MSc

CONTACT

+56229788038; mgarridom@hcuch.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The enrollers, evaluators and healthcare personnel (nurses, physical therapists, physicians, occupational therapists) do not know the assigned group. Both groups receive a tablet of the same dimensions and with the same basic applications. However, blinding the patient is not possible, since when exploring the tablet, he or she will recognize whether or not it has the PREVEDEL program included. To reduce this bias, the staff that delivers the tablet encourages both groups to use its different basic applications (access the Internet) and that any doubts may have participants about its use should be made to the tablet coordinator, so that the evaluators or healthcare personnel remain masked. The time between assignment and delivery of the tablet is between 4 to 12 hours in all participating centers. This variable will be measured for later analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eduardo Tobar, Associated professor

Model Details: Multi-center, parallel-group, randomized controlled trial (RCT). CONSORT methodological recommendations are used for reporting non-pharmacological trials, in addition to TIDieR and SPIRIT recommendations.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: November 4, 2021
• Study Start: August 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: January 15, 2023
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

CL (1)