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

Dementia Clinical Trial

— TID  

Official title:

Pilot Study of a Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183351
• Other study ID #: MID
• Status: Completed
• Phase: N/A
• First received: August 13, 2010
• Last updated: December 11, 2014
• Start date: May 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2011
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
Norway	Department for Research and Development, Innlandet Hospital Trust	Hamar

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	Norwegian Medical Association

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory)		8 months	No
Secondary	The Cornell scale for depression in dementia (CSDD)		8 months	No
Secondary	Neuropsychiatric Inventory (NPI ) which measures neuropsychiatric symptoms and behaviour		8 months	No
Secondary	Lawton's self-maintenance scale (Lawton and Brody 1969), which measures function in activities of daily living (ADL)		8 months	No
Secondary	Quality of life in Alzheimers's Disease (QUALID) (Weiner et al. 2000), which measures quality of life		8 months	No
Secondary	Staff measures: Psychosocial factors in work life will be measured by a scale developed by Sund (1992).		8 months	No
Secondary	Use of antipsychotic drugs		8 months	No
Secondary	Staff measures:P-cat:Person-centered Care Assessment Tool	Measure of the degree of person-centered dementia care in the unit	8 months	No