Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia (TID)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2010 | ||||
| Last Updated Date | May 3, 2011 | ||||
| Start Date ICMJE | May 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory) [ Time Frame: 8 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Agitation measured by the C-MAI (The Cohen-Mansfield Agitation Inventory) [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01183351 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
the Cornell scale for depression in dementia (CSDD) [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia | ||||
| Official Title ICMJE | Pilot Study of a Multidisciplinary Intervention for Challenging Behaviour (Agitation) in Patients With Dementia | ||||
| 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. |
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| 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.
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Dementia | ||||
| Intervention ICMJE | 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:
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| Study Arm (s) | Experimental: Psychosocial intervention
This is a single-group pilot-study
Intervention: Behavioral: Psychosocial intervention |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 35 | ||||
| Estimated Completion Date | May 2012 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01183351 | ||||
| Other Study ID Numbers ICMJE | MID | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Unni Aaboen, Research Centre for Old Age Psychiatry Research, Innlandet Hospital trust | ||||
| Study Sponsor ICMJE | Sykehuset Innlandet HF | ||||
| Collaborators ICMJE | Norwegian Medical Association | ||||
| Investigators ICMJE |
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| Information Provided By | Sykehuset Innlandet HF | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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