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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychosocial intervention
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia, Agitation, Challenging behaviour, Behavioural and psychological symptoms in dementia (BPSD)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department for Research and Development, Innlandet Hospital Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychosocial intervention

Arm Description

This is a single-group pilot-study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Cornell scale for depression in dementia (CSDD)
Neuropsychiatric Inventory (NPI ) which measures neuropsychiatric symptoms and behaviour
Lawton's self-maintenance scale (Lawton and Brody 1969), which measures function in activities of daily living (ADL)
Quality of life in Alzheimers's Disease (QUALID) (Weiner et al. 2000), which measures quality of life
Staff measures: Psychosocial factors in work life will be measured by a scale developed by Sund (1992).
Use of antipsychotic drugs
Staff measures:P-cat:Person-centered Care Assessment Tool
Measure of the degree of person-centered dementia care in the unit

Full Information

First Posted
August 13, 2010
Last Updated
December 11, 2014
Sponsor
Sykehuset Innlandet HF
Collaborators
Norwegian Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT01183351
Brief Title
Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia
Acronym
TID
Official Title
Pilot Study of a Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
Norwegian Medical Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. 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. 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Agitation, Challenging behaviour, Behavioural and psychological symptoms in dementia (BPSD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial intervention
Arm Type
Experimental
Arm Description
This is a single-group pilot-study
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial intervention
Other Intervention Name(s)
Multidisclinary Intervention in Dementia patients, Psychosocial intervention for challenging behavior
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory)
Time Frame
8 months
Secondary Outcome Measure Information:
Title
The Cornell scale for depression in dementia (CSDD)
Time Frame
8 months
Title
Neuropsychiatric Inventory (NPI ) which measures neuropsychiatric symptoms and behaviour
Time Frame
8 months
Title
Lawton's self-maintenance scale (Lawton and Brody 1969), which measures function in activities of daily living (ADL)
Time Frame
8 months
Title
Quality of life in Alzheimers's Disease (QUALID) (Weiner et al. 2000), which measures quality of life
Time Frame
8 months
Title
Staff measures: Psychosocial factors in work life will be measured by a scale developed by Sund (1992).
Time Frame
8 months
Title
Use of antipsychotic drugs
Time Frame
8 months
Title
Staff measures:P-cat:Person-centered Care Assessment Tool
Description
Measure of the degree of person-centered dementia care in the unit
Time Frame
8 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Selbaek, MD PhD
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Study Chair
Facility Information:
Facility Name
Department for Research and Development, Innlandet Hospital Trust
City
Hamar
ZIP/Postal Code
2312
Country
Norway

12. IPD Sharing Statement

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

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