|- candidate number||15662|
|- NTR Number||NTR4248|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-nov-2013|
|- Secondary IDs||VU University: WC_2012-025; CBP_2013-6 Inholland University of Applied Sciences, Zorgkantoren Co÷peratie VGZ|
|- Public Title||De implementatie van de Veder Methode in de dagelijkse zorg bij ouderen met dementie, die verblijven in woon-zorgcentra.
(Implementation study Veder Method)|
|- Scientific Title||Study into the implementation of the Veder Method in the 24-hour care for people with dementia living on nursing home wards. |
|- hypothesis||The Veder Method can be succesfully implemented in daily care of elderly with dementia and leads to a higher quality of care, higher job satisfaction of the caregivers and greater patient satisfaction. |
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||People with dementia who live on the participating nursing home, the control or experimental ward. Informed consent
All caregivers whom are working in day and/or eveningshifts.
|- Exclusion criteria||Tempory staff, students and caregivers working only at night are not eligible to participate. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||14-nov-2012|
|- planned closingdate||1-jun-2016|
|- Target number of participants||170|
|- Interventions||All caregivers from the participating nursing homes receive a training of the Veder Method. This lasts at about 9 months and consisted of education about the Veder Method, coaching-on-the-job and coaching meetings.
The caregivers from the participating control wards do not receive this training. |
|- Primary outcome||How the Veder Method is implemented and used by the caregivers in the daily care of people with dementia and what conditions are needed for a succesful implemention. (focusgroups, interviews, selfreportlists: DementiaZelfbeoordelingsvragenlijst Belevingsgerichte Vaardigheden in de Omgang met dementerende Ouderen)|
|- Secondary outcome||1. Quality of care (Observation lists: Quality of Caregivers Behaviour in dementia care and the 'Veder Methode in de 24-uurszorg; selfreport Approaches to Dementia Questionnaire) |
2. Behaviour and quality of life of elderly with dementia (Observationlists: Qualidem and Interact)
3. Jobsatisfaction of caregivers (Leiden quality of work questionnaire, focusgroups).
|- Timepoints||Pre-test before intervention, post-test after the intervention (between 9 and 12 months after pre-test). |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| P. Boersma|
|- CONTACT for SCIENTIFIC QUERIES|| P. Boersma|
|- Sponsor/Initiator ||Hogeschool INHolland, Vrije Universiteit Amsterdam, Fonds NutsOhra, University of Amsterdam (UvA)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background of the study:|
Dementia is characterized by memory problems, trouble with the language (aphasia), recognition (agnosia), action (apraxia) and problems with executive functions.
As dementia gradually progresses 80 to 90% of people with dementia will develop psychological symptoms and complaints, such as depression, apathy, agitation, aggression, anxiety and psychosis which seriously hamper the care. Difficult interactions can lead to caregivers experiencing stress and / or an increased workload. This may be associated with decreased job satisfaction and even lead to burnout. Both people with dementia, and their caregivers, may benefit from improved demand- or person centred care. However, the offer of person centred dementia care requires an understanding of needs, wishes and preferences of people with dementia and specific care expert skills.
The Veder Method is an innovative person centred care method that supports employees to give people with dementia a more person-centered care.
The Veder methods reaches out to them through theatre, song and poetry to go back in time to the period when the elderly with dementia were young. By reminiscence - evoking memories - using objects from the past, for example, pictures, songs and games creates recognition and thus recognition of who one was and is. This evokes a feeling of safety. A re-experience - even for a brief moment - of identity. This well-being provides the opportunity for better communication in present situations.
By integrating the Veder Method in 24-hour care the care can be given in a more personalized way. A more lasting effect may be expected on mood and behaviour of people with dementia when (elements) of the method are structurally integrated in the daily care, such as during meals and in the living room.
Objective of the study:
The main question addressed in this study is how the introduction of the Veder Method in the 24-hour care at Nursing home wards takes place and what the conditions for a successful integration of the Veder Method are. Subsequently the study determinates (second question) whether the introduction of the Veder Method has a positive effect on:
- the quality of care provided;
- the behaviour and quality of life of people with dementia;
- the job satisfaction of caregivers.
For answering the main question the study will be carried out as a longitudinal one-group design. The focus in answering this research question is on the description of the implementation process and tracing barriers as well as facilitators in the implementation, from which favourable conditions for successful implementation can be distilled.
The research tools used for this are:
-Care plan analysis
-Focus groups with caregivers.
-Interviews with key figures.
The second question investigates the implementation effectiveness (the extent to which the implementation is successful). With a pretest-posttest control group design the following research instruments were used to answer this question:
-Care plan analysis
-Focus groups with nursing staff
-Interviews with key figures
-Observations of caregivers and residents with dementia during 24-hour care
-Self Report Questionnaire for nursing staff on work experience and quality of care.
Care plan analysis, observations and questionnaires on work experience and quality of care are carried out on two occasions: before the implementation of the Veder Method in the 24-hour care and after the implementation of the Veder Method in the 24-hour care.
Study of the population:
The survey is conducted on minimal seven experimental nursing home wards, and minimal five control nursing home wards.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Participation in this study is for the elderly with dementia a very small burden: in the living room of the nursing homes researchers observe during 6 hours the behaviour of the elderly and the interactions between the elderly and their caregivers. If they are able to, the elderly were asked a few questions about their cognition and one question about their experienced quality of life.
Participation for the caregivers is more time consuming. Before and after the intervention they need to fill in a self-report questionnaire and will be asked to participate in a focus group after the intervention. Given the nature of the study, we expect that all elderly with dementia and their caregivers benefit from the training of the Veder Method.
There are no risks associated with participation.
|- Main changes (audit trail)|
|- RECORD||4-nov-2013 - 20-nov-2013|