|- candidate number||13337|
|- NTR Number||NTR3620|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-sep-2012|
|- Secondary IDs||R0001593 UMCN|
|- Public Title||TENSE-study.|
|- Scientific Title||Training and Educating Nurses Effectively.|
|- hypothesis||Training nurses in managing challenging behavior of clients with dementia will improve their work satisfaction and decrease their work stress in the short and long term.|
Challenging behavior of the clients will decrease as an effect of the program.
|- Healt Condition(s) or Problem(s) studied||Dementia, Exercise, Education, Challenging behavior, Nursing staff|
|- Inclusion criteria||Nursing homes will be included if:|
1. They have at least two DSC Units (Dementia Special Care Units);
2. Nursing staff members work on one unit exclusively;
3. One care team cares for at least fifteen residents that are diagnosed with dementia;
4. Units that participate will not undergo a reorganization or other interventions within a half year before or during the study that can influence the research.
Residents will be included if:
1. They are diagnosed with dementia according to DSM-IV-TR criteria;
2. They are living longer than a month in the nursing home.
Nurses will be included if they:
1. Are being employed for at least three months and not expected to be transferred to another unit within the study period;
2. Have at least been working on the unit for three months;
3. Work more than one day a week.
|- Exclusion criteria||1. Not fullfilling the inclusion criteria;|
2. Declining participation in this study by the representative of the client.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2012|
|- planned closingdate||31-dec-2013|
|- Target number of participants||240|
|- Interventions||Nursing homes randomized to the intervention group, will receive a training course about challenging behavior of people with dementia that is tailored to the needs and wishes of the institution and of the nursing staff that is trained. In total the training will take three sessions of 2.5 hours (to be given in three or six weeks), two follow up meetings (after three and six months) and four measurements (before the training, immediately after the training, three months after the training and nine months after the training). The training course includes the following elements: knowledge about dementia; knowledge about the origin of challenging behavior and how to manage it; knowledge about what factors cause challenging behavior and how to signal signs of impending challenging behavior; practical training of behavior management skills. Specific features of the training are its follow up sessions designed to make continuous education possible and its individually tailored design.
In nursing home units randomized to the control group, usual care is continued.
|- Primary outcome||For nurses:|
1. Knowledge about the origin and how to manage challenging behavior (a self-developed knowledge test);
2. Work stress;
3. Work load;
4. Work satisfaction;
5. Emotional reactions at work.
1. Challenging behavior.
|- Secondary outcome||For residents:|
1. Quality of life;
2. Social Engagement.
|- Timepoints||0, 2, 5 and 11 months.|
|- Trial web site||www.tense-studie.nl|
|- CONTACT FOR PUBLIC QUERIES||Drs. T.J.G.M. Hazelhof|
|- CONTACT for SCIENTIFIC QUERIES||Mw. Dr. D.L. Gerritsen|
|- Sponsor/Initiator ||Radboud University Nijmegen Medical Centre|
(Source(s) of Monetary or Material Support)
|- Brief summary||Challenging behaviour exhibited by people with dementia can have adverse outcomes for nursing staff. Training nursing staff to manage this behaviour may reduce the impact of this behaviour. Although much of the research into training programs suffers from a weak design, some studies find some effect of training programs on knowledge about challenging behaviour and on management of challenging behaviour. Effects on stress or burnout are almost not found. To be more effective, a training has to be tailored to the needs of the institution. Sustaining the effects can be possible by using follow up sessions, on the job training and feedback.
The TENSE-study is a randomized controlled study investigating the effects of a continuous training program on work stress, work satisfaction and self-efficacy of nursing staff (n=120) and on challenging behaviour of clients with dementia (n=120). The main outcomes for nursing staff are knowledge about challenging behaviour, work stress and work satisfaction. The main outcome for clients is the frequency of challenging behaviour. Secondary outcomes for clients are quality of life and perceived quality of care. A process evaluation will take place.
The TENSE-Study presented here is a randomized controlled study into the effects of a tailor-made training program for nursing staff in managing challenging behavior.
|- Main changes (audit trail)|
|- RECORD||19-sep-2012 - 4-jan-2013|