- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01183351
Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia (TID)
Pilot Study of a Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hamar, Norway, 2312
- Department for Research and Development, Innlandet Hospital Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Psychosocial intervention
This is a single-group pilot-study
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory)
Time Frame: 8 months
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8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Cornell scale for depression in dementia (CSDD)
Time Frame: 8 months
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8 months
|
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Neuropsychiatric Inventory (NPI ) which measures neuropsychiatric symptoms and behaviour
Time Frame: 8 months
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8 months
|
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Lawton's self-maintenance scale (Lawton and Brody 1969), which measures function in activities of daily living (ADL)
Time Frame: 8 months
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8 months
|
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Quality of life in Alzheimers's Disease (QUALID) (Weiner et al. 2000), which measures quality of life
Time Frame: 8 months
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8 months
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Staff measures: Psychosocial factors in work life will be measured by a scale developed by Sund (1992).
Time Frame: 8 months
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8 months
|
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Use of antipsychotic drugs
Time Frame: 8 months
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8 months
|
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Staff measures:P-cat:Person-centered Care Assessment Tool
Time Frame: 8 months
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Measure of the degree of person-centered dementia care in the unit
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8 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Geir Selbaek, MD PhD, Sykehuset Innlandet HF
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MID
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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