Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Sykehuset Innlandet HF.
Recruitment status was  Recruiting
Norwegian Medical Association
Information provided by:
Sykehuset Innlandet HF Identifier:
First received: August 13, 2010
Last updated: May 3, 2011
Last verified: May 2011

August 13, 2010
May 3, 2011
May 2011
December 2011   (final data collection date for primary outcome measure)
Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01183351 on Archive Site
  • The Cornell scale for depression in dementia (CSDD) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI ) which measures neuropsychiatric symptoms and behaviour [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Lawton's self-maintenance scale (Lawton and Brody 1969), which measures function in activities of daily living (ADL) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Quality of life in Alzheimers's Disease (QUALID) (Weiner et al. 2000), which measures quality of life [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Staff measures: Psychosocial factors in work life will be measured by a scale developed by Sund (1992). [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Use of antipsychotic drugs [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Staff measures:P-cat:Person-centered Care Assessment Tool [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Measure of the degree of person-centered dementia care in the unit
the Cornell scale for depression in dementia (CSDD) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia
Pilot Study of a Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia

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.

Intervention description:

Initially the intervention group will receive education about dementia, BPSD, quality of care and use of psychotropic drugs Subsequently, staff in the nursing home will receive training in the intervention method: MID. Two or three nurses from each nursing home will receive more intensive training in the method to ensure effective implementation of the method in daily practice. After this initial period that will last for four weeks, trained research nurses will visit each nursing home every fortnight ensuring that the intervention is properly implemented and thereby assure adherence to the treatment protocol.

Description of the intervention Multidisciplinary Intervention model for challenging behaviour in Dementia, MID, consists of three stages: a registration-observation stage, a staff guiding stage, and an evaluation stage.

  1. Registration-observation stage:

    The nurses use a daily registration sheet for the actual types of behaviour that are challenging. This ensures that the behaviour is properly observed on a daily basis.

    The next step in the registration-observation stage is:

    • Collection of the medical history by the nursing home nurses
    • Standard physical examination by the nursing home physician
    • Critical review of medication by the nursing home physician
    • Pain assessment (clinical), by the nursing home physician
    • Assessment of the type and degree of dementia by the nursing home physician
    • Assembly of the patients personal history by the nursing homes nurses After completion of the registration-observation stage (lasting 1 day up to 4 weeks) the staff guiding stage starts.
  2. Staff guiding stage - guiding meeting The trained nurses from the nursing home set a meeting for 1-1,5 hours for the nursing home health workers. The meeting is lead by the nursing home nurses and the nursing home physician.

    The meeting follows a structured agenda and is conducted following the principles of problem solving in cognitive behavioural therapy taking into account one type of challenging behaviour at a time. Results from the registration-observation stage are presented at the beginning of the meeting. (A 5-column sheet, based on classical cognitive change thoughts records, is used to structure problem solving during the meeting: 1.facts, 2.interpretations (thoughts), 3.feelings, 4. solutions/actions and 5. evaluation)

  3. Evaluation stage This stage starts just after the guiding meeting and is conducted by the nursing home nurses. The nurses continue the same registration of the behaviour on a daily basis as in the registration-observation stage for the next 4 weeks.
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Behavioral: Psychosocial intervention
Multidisciplinary 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.
Other Names:
  • Multidisclinary Intervention in Dementia patients
  • Psychosocial intervention for challenging behavior
Experimental: Psychosocial intervention
This is a single-group pilot-study
Intervention: Behavioral: Psychosocial intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2012
December 2011   (final data collection date for primary outcome measure)

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.
Not Provided
Contact: Bjørn Lichtwarck, MD 004797523048
Unni Aaboen, Research Centre for Old Age Psychiatry Research, Innlandet Hospital trust
Sykehuset Innlandet HF
Norwegian Medical Association
Study Chair: Geir Selbaek, MD PhD Sykehuset Innlandet HF
Sykehuset Innlandet HF
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP