- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03260335
A Biofeedback Intervention for the Prevention of Challenging Behaviour
A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A multiple baseline "A-B-A" single case experimental design will be adopted with baseline, intervention, and return to baseline phases.
Participants will wear the portable monitoring device with heart rate monitor, pedometer and global positioning system (GPS) functions. A pre-calculated algorithm, developed using machine learning software will be used to predict challenging behaviour episodes 2-4 hours in advance of the event. Recent research has developed a best predictor model with a sensitivity of 82% and specificity of 42%, when averaged across two participants (in press). The device will communicate with a smart phone, via Bluetooth connectivity, when an event has been predicted.
Following enrolment in the study, participants will be randomly assigned to a treatment start time, which will follow from an initial baseline phase. During the baseline phase, participants will wear a commercially available smart watch with physiological monitoring capability, for at least one month in order to gather behaviour frequency data, and associated physiological data; no prompts will be provided. During this period, behavioural and physiological data will be sent to a secure server where a machine learning algorithm will examine the relationships between data streams and 'self-tune' to improve its prediction of challenging behaviour episodes. In the treatment phase, participants and staff will receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart watch/connected mobile phone, when an event has been predicted. This will prompt participants to implement a proactive anxiety management strategy, and will prompt staff to support the participant in completing this, if required. The strategy used will be predetermined in the participant's standard care plan e.g. breathing relaxation, reframing the problem, behavioural redirection. Details will be recorded using an adapted version of the Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in which the biofeedback prompt occurred, participant and staff responses to the biofeedback prompt, and any resulting behaviours, including the occurrence of challenging behaviour. Following the intervention phase, participants will return to a baseline phase for one month, in which no prompts will be provided. Again, details of any challenging behaviour will be recorded via the OAS-MNR.
Undersøgelsestype
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- participants who have sustained a severe injury to the brain, as determined by length of unconsciousness (greater than 24 hours), a Glasgow Coma Scale of 3 to 8 and a Post Traumatic Amnesia period greater than 1 day
- participants who are resident in the Graham Anderson House, Brain Injury Rehabilitation (BIRT) Unit
- participants presenting with challenging behaviour, during the recruitment period
- participants will NOT be excluded on the basis of comorbid psychiatric disorders or drug/alcohol use, in order to provide conclusions representative of the clinical population
- participants will NOT be excluded on the basis of being unable to provide informed consent, in order to provide conclusions representative of the clinical population
Exclusion Criteria:
- a level of cognitive impairment that would prevent individuals from understanding the feedback obtained via digital or verbal prompts
- participants without the capacity to consent, that do not provide verbal assent to participate in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Biofeedback intervention
Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan
|
Anxiety management strategy as per standard care plan
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of incidents of challenging behaviour
Tidsramme: 5 months
|
Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
|
5 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Implementation of anxiety management strategy
Tidsramme: 5 months
|
Number of times anxiety management strategy successfully employed
|
5 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Jonathan Evans, BSc PhD, University of Glasgow
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17/SS/0119
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Erhvervet hjerneskade
-
Asan Medical CenterSeoul National University Bundang Hospital; EverEx Inc.RekrutteringICU Acquired Weakness (ICUAW)Sydkorea
-
University of MinnesotaRekruttering
-
Virginia Polytechnic Institute and State UniversityTrukket tilbage
-
BraindexClinique de la SauvegardeAfsluttetAnæstesi | Brain MonitorFrankrig
-
Assistance Publique Hopitaux De MarseilleUkendt
-
National Institute of Mental Health (NIMH)AfsluttetKÆLEDYR | Brain Imaging | Cannabinoid | CB1Forenede Stater
-
GE HealthcareAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Mayo ClinicAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Truway Health, Inc.Tilmelding efter invitationEvaluering af In-Vitro Cryo Terapeutiske Protokoller på Humane Celleprøver (TWH-CRYO-001) (CRYO-IVT)Cellular Injury and Post-Cryogenic Recovery | Kryogenisk cellulær stress | Kuldeinduceret cellulær skade | Termisk Skade Reaktion | Post-thaw levedygtighedsforringelse | Osmotisk Stressskade | Biomekanisk Skadesmodellering (In-Vitro) | Blunt Force Injuries to the Extremities (Cellular Injury Model) | Vævsskade... og andre forholdForenede Stater
-
Capital Medical UniversityChina-Japan Friendship Hospital; Beijing Municipal Health CommissionIkke rekrutterer endnuCommunity Acquired Pneumonia (CAP)Kina
Kliniske forsøg med Anxiety management strategy
-
Instituto Mexicano del Seguro SocialEscuela Superior de Medicina, Instituto Politécnico Nacional; Doctorado... og andre samarbejdspartnereIkke rekrutterer endnuPædiatrisk fedme | Fedme hos børn | Overvægt i barndommenMexico
-
Ibn Haldun UniversityAfsluttetAngst | Depressive symptomer | Angstlidelser og symptomer | Følelsesmæssig dysregulering | SorgTyrkiet (Türkiye)
-
Nova Scotia Health AuthorityCanadian Institutes of Health Research (CIHR); IWK Health CentreAfsluttet
-
The University of Texas at DallasMeadows Foundation; Hoglund FoundationRekruttering
-
Mclean HospitalAfsluttetTvangslidelse | Social angst | Paniklidelse | Separationsangst | Specifik fobi | AgorafobiForenede Stater
-
University of OregonAfsluttet
-
Boston Medical CenterBreast Cancer AllianceTrukket tilbage
-
Asst. Prof. Dr. Suleyman Emre MeseliAfsluttet
-
MED-EL Elektromedizinische Geräte GesmbHRekrutteringSensorineuralt høretab, bilateraltFrankrig
-
Karadeniz Technical UniversityOnur Yilmaz; Pinar SivrikayaAfsluttetTandlægeangst | Timing i tandlæge-patientkommunikationKalkun