|- candidate number||20383|
|- NTR Number||NTR4815|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-okt-2014|
|- Secondary IDs||2013/362 METC|
|- Public Title||Effects of a behavioral intervention for agitation of people with dementia
|- Scientific Title||A behavioral intervention for agitation of people with dementia living at home versus care as usual.|
|- hypothesis||In the Netherlands, case managers play an essential role in the care chain for people with dementia living in the community. Because the profession has just been started, there is a lack of evidence-based practice to provide treatment for agitation and other challenging behavior of people with dementia living at home with an informal caregiver. |
The objective of this study is to develop an evidence-based individualized intervention to treat or prevent agitation among people with dementia living in the community with the help of an informal caregiver and to compare the effectiveness of this individualized approach with care as usual. We expect that the effect on agitation of people with dementia (frequency and/or disruptiveness for the caregiver) is larger in the intervention group than the control group.
|- Healt Condition(s) or Problem(s) studied||Dementia, Alzheimer, Challenging behavior, Case-management, Informal care-givers|
|- Inclusion criteria||The inclusion criteria for regional dementia chains are: |
1. The job of case managers in the chain includes treatment. We want to include case managers who not only, coordinate the care, but also provide treatment to the dyads. With treatment we mean the activities of the case manager that are methodical performed with the purpose to influence or improve the disease, symptoms and limitations of the person with dementia and the caregiver;
2. A psychologist is available for consultation;
3. The case manager is in contact with the general practitioners.
The inclusion criterium for case managers is:
1. Working as a casemanager for at least 16 hours per week.
The inclusion criteria for the people with dementia are:
1. Living in the community;
2. Having a diagnosis of dementia according to the file of the general practitioner;
3. Having at least a positive score on two items of the questionnaire measuring several types of agitation (CMAI; see measurements);
4. Having a caregiver with at least a score of >=4 (very much or extremely) on at least two items of the CMAI disruptiveness scale;
5. Not using psychotropic drugs or being on a stable dose of psychotropic medication. With a stable dose we mean that the dose of psychotropic medication is not changed since 6 weeks before baseline.
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2012|
|- planned closingdate||1-jul-2016|
|- Target number of participants||160|
|- Interventions||The dyads in the experimental condition will receive the structured and tailor-made intervention that consists of a cycle of analyzing the behavior of the person with dementia and formulating and evaluating a treatment program tailored to the person's past, identity, preferences and abilities. The intervention will be carried out by case managers, professionals specialized in dementia care, in cooperation with the person with dementia and family caregiver. The family caregiver wherever possible together with the person with dementia, will carry out the treatment program.
|- Primary outcome||Person with dementia: frequency of the agitated behaviors of the person with dementia, frequency of the targeted agitated behaviors, desired behavior.
Informal Caregiver: perceived disruptiveness of the agitated behaviors by the caregiver, perceived disruptiveness of the targeted agitated behavior.
|- Secondary outcome||Person with dementia: quality of life of the person with dementia, frequency and severity of behavioral problems, use of psychotropic medication, movement to long term care facility.
Informal Caregiver: the current mental health, the level of perceived caregiver burden due to informal caregiving and self-efficacy.
The person with dementia and the informal caregiver together: the relationship quality
|- Timepoints||The study proposed is a RCT with an intervention period of 15 weeks and three measurements: pre- (T0), amid- (T1; 7 weeks from baseline) and post-measurement (T2) in the experimental and control group, and a follow-up measurement (T3) after 3 months in the experimental group only.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. B. Willemse|
|- CONTACT for SCIENTIFIC QUERIES||Drs. B. Willemse|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction|
(Source(s) of Monetary or Material Support)
|- Brief summary||The consequences of agitation among people with dementia living in the community are often far-reaching: reduced quality of life of people with dementia themselves, increased burden of the informal caregivers, and acceleration of nursing home placement with a substantial impact on the already high costs of long term care (Pot, 1996; de Vugt, 2004; Gaugler et al., 2009). In the Netherlands, case managers play an essential role in the care chain for people with dementia living in the community. Because the profession has just been started, there is a lack of evidence-based practice to provide treatment for agitation and other challenging behavior of people with dementia living at home with an informal caregiver. |
The objective of this study is to study the effect of an evidence-based individualized intervention to treat or prevent agitation among people with dementia living in the community with the help of an informal caregiver. The individualized intervention consists of a cycles of analyzing the behavior of the person with dementia and formulating and evaluating a treatment program, based on the behavioral analyses, tailored to the person's past identity, preferences and abilities.
The study entails a Randomized Controlled Trial (RCT) on the effectiveness of this individualized and structured approach to reduce or prevent agitation among people with dementia in comparison with care as usual. This RCT has three measurements in the experimental and control group, and a follow-up measurement in the experimental group only. Cluster-randomization of 16 regional dementia chains will be used (8 control; 8 experimental). In total 40 case managers will be included (2-5 case-managers per dementia care chain) and 80 dyads per condition will be included, 160 dyads in total.
|- Main changes (audit trail)|
|- RECORD||16-okt-2014 - 27-okt-2014|