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Grip op probleemgedrag bij jonge mensen met een dementie: de Beyond-II studie


- candidate number21706
- NTR NumberNTR5018
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-feb-2015
- Secondary IDs733050402 ZonMW
- Public TitleGrip op probleemgedrag bij jonge mensen met een dementie: de Beyond-II studie
- Scientific TitleGrip on neuropsychiatric symptoms in young-onset dementia: the Beyond-II study
- ACRONYMBeyond-II
- hypothesisRates of neuropsychiatric symptoms are extremely high in institutionalized people with young-onset dementia. Neuropsychiatric symptoms are associated with reduced quality of life of residents and higher caregiver burden. Therefore, the Grip care program on challenging behavior will be adapted to the specific characteristics and needs of people with young-onset dementia. This will result in a multi-component intervention on the reduction of neuropsychiatric symptoms, which consists of the detection, analyses, treatment and evaluation of neuropsychiatric symptoms. We assume that there is a significant effect of the multi-component intervention on the reduction of neuropsychiatric symptoms, especially agitation and aggression in people with young-onset dementia residing on young-onset dementia special care units.
- Healt Condition(s) or Problem(s) studiedNeuropsychiatric disorders, Early-onset dementia, Symptom burden
- Inclusion criteriaResidents of young-onset dementia special care units (YOD SCU’s) of the Dutch young-onset dementia Knowledge Centre (DKC) with an established dementia diagnosis according to regular criteria will be included in the study. Residents with a symptom onset before the age of 65 are included in the study, thus residents can be over the age of 65. Prerequisite for inclusion will be informed consent of the resident and/or his legal representative. Deceased and discharged residents are replaced by newly admitted residents.
- Exclusion criteriaResidents with symptom onset after the age of 65 or residents with a history of other neurological disorders (i.e. head injury, stroke, Korsakoff’s syndrome, multiple sclerosis) will be excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate31-mrt-2017
- Target number of participants200
- InterventionsIn this intervention study, the adapted Grip on challenging behavior care program will be implemented at ten YOD SCU's. A stepped wedge design will be used in which eventually all special care units will work according to the care program. The special care units will be randomly divided into three clusters. Cluster 1 will be the first to start working with the care program. They will receive psycho-education on specific characteristics of people with young-onset dementia and a training on how to use the care program. Cluster 2 and 3 are in the control condition and will receive care as usual. After six months Cluster 1 will receive a follow up training session. Six months after start of the intervention study cluster 2 will start using the care program, cluster 3 remains in the control condition at that time. Finally, cluster 3 will start using the care program, which will be 12 months after start of the intervention study. The total duration of the intervention study will be 18 months.
- Primary outcomeAgitation and Aggression as measured with the Dutch version of the Cohen-Mansfield Agitation Inventory (CMAI-D) Neuropsychiatric Symptoms measured with the Dutch version of the Neuropsychiatric Inventory-NH version (NPI-NH)
- Secondary outcomeResident related outcomes:
Quality of life of the resident measured with the Quality of Life in Dementia (Qualidem)
Psychotropic drug use (PDU) will be derived from medical files and classified using the Anatomical Therapeutical Chemical Classification.

Nursing staff related outcomes:
Workload measured with the Utrecht Burnout Scale-C (UBOS-C)
Job satisfaction and work/time pressure is assessed with two subscales of the Leiden Quality of Work Questionnaire Absence rate will be retrieved from periodical registrations done by the personnel departments of participating nursing homes.

Other outcomes:
Sociodemographic variables
Length of stay in the nursing home
Dementia Type will be classified with the DSM-IV-TR
Dementia severity with the Global Detoriation Scale (GDS)
Environmental factors of the dementia care unit will be assessed with the Therapeutic Environment Screening Survey for nursing homes (TESS-NH)
Nursing staff attitude will be measured with the Approaches to Dementia Questionnaire (ADQ)
- TimepointsT0 (September 2015): All variables/outcomes will be assessed.
T1 – T3 (interval every 6 months starting from T0): all variables will be assessed with the exception of sociodemographic variables, length of stay in the NH, dementia type and the environmental factors.
- Trial web site-
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESMSc, PhD Christian Bakker
- CONTACT for SCIENTIFIC QUERIESMSc, PhD Christian Bakker
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Alzheimer Nederland, Stichting Kenniscentrum Dementie op Jonge Leeftijd, Archipel Zorggroep, Stichting Florence
- Publications-
- Brief summaryThe Behavior in Young-Onset Dementia-II study focuses on improving the detection, analysis, treatment and evaluation of challenging behavior in people with young-onset dementia residing in nursing homes. This study consists of five consecutive workpackages. In workpackage 1 the existing care program ‘Grip on challenging behavior’ will be adapted and tailored for use in people with young-onset dementia residing in nursing homes. In workpackage 2 an enhanced implementation strategy will be developed, which contains a digitalization of the care program. In workpackage 3 the effectiveness of the care program will be evaluated using a stepped wedge design. In 18 months time the care program will be implemented on ten special care units for people with young-onset dementia in the Netherlands. The special care units will randomly switch from control to intervention condition, eventually all special care units will receive the care program. Next, the feasibility, satisfaction and actual use of the care program will be determined and the consequences of the costs of the implementation will be analyzed (workpackage 4). In workpackage 5 a blueprint for a care program at home will be developed.
- Main changes (audit trail)
- RECORD20-feb-2015 - 11-apr-2015


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