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Dementia | Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia

Dementia research study

What is the primary objective of this study?

The increasing prevalence of dementia is a major challenge to the health authorities in most countries. Nearly all the persons suffering from dementia experience behavioural and psychological symptoms (BPSD). The prevalence of BPSD is particularly high in nursing homes. BPSD are often treated with psychotropic drugs even though the evidence for effect is minimal and the risk of serious adverse events is considerable. All the major treatment recommendations advise that non-pharmacological measures should be applied first when treating BPSD even though the evidence for such treatment is limited. The investigators will conduct a pilot study of a non-pharmacological treatment for BPSD. The method has been developed in Norway and has already been implemented in a number of nursing homes in the county of Nordland.

Who is eligible to participate?

Inclusion Criteria: - Patients are eligible for inclusion if they have a possible or probable dementia diagnosis and clinically significant agitation score 6 or higher (as measured by the CMAI: Cohen-Mansfield Agitation Behaviour - A permanent stay in nursing home of at least 4 weeks - Given verbal or written assent for participation or has written consent given on their behalf by their next of kin Exclusion Criteria: - Lack of consent, terminal state,unremitting pain.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dementia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Psychosocial interventionMultidisciplinary Intervention for challenging behavior in patients with Dementia (MID) is developed in clinical practice in nursing homes as an answer to the need of a systematic and simple tool for the nursing home health workers to meet agitation. The model is based on the theoretical framework of cognitive behavioural therapy (CBT) where human behaviour is understood as always acting under the influence of biological, social and psychological factors. The systematic and structured approach of CBT to problem solving is central and is transformed in the model to meet the specific characteristics of challenging behaviour in dementia.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Psychosocial interventionThis is a single-group pilot-study

Study Status

Completed

Start Date: May 2011

Completed Date: August 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory)

Secondary Outcome: The Cornell scale for depression in dementia (CSDD)

Study sponsors, principal investigator, and references

Principal Investigator: Geir Selbaek, MD PhD

Lead Sponsor: Sykehuset Innlandet HF

Collaborator: Norwegian Medical Association

More information:https://clinicaltrials.gov/show/NCT01183351

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