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Improving the treatment of neuropsychiatric symptoms in nursing home residents suffering from dementia
DOI 10.1186/ISRCTN43578978
ClinicalTrials.gov identifier
EudraCT number
Public title Improving the treatment of neuropsychiatric symptoms in nursing home residents suffering from dementia
Scientific title Evaluation of a combined guideline implementation protocol for neuropsychiatric symptoms in nursing home residents suffering from dementia
Serial number at source LT 44-076
Study hypothesis The implementation of guideline-driven training and occupational therapy interventions will reduce neuropsychiatric symptoms, specifically, agitation, depression, and apathy, in nursing home residents suffering from dementia
Lay summary Not provided at time of registration
Ethics approval Ethics Committee of Charite - University Medicine Berlin approved on the 17th of July 2008 (ref: EA1/065/08)
Study design Cluster randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Neuropsychiatric symptoms in dementia
Participants - inclusion criteria Both male and female dementia patients aged 60 or older who live in a nursing home
Participants - exclusion criteria 1. Inability to give informed consent and absence of a caregiver holding power of attorney
2. Any of the following conditions as defined by ICD-10 criteria
2.1. Presence of substance abuse (F 10)
2.2. Schizophrenia and associated conditions (F20)
2.3. Bipolar disorder (F30,31)
Anticipated start date 01/11/2008
Anticipated end date 01/05/2010
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet (in German)
Target number of participants 400 (from 18 Berlin nursing homes)
Interventions 18 care centres in Berlin will be randomised to the intervention or control conditions:
1. Intervention centres:
1.1. 20 hours of training for nursing staff on causes, symptomatology and treatment of neuropsychiatric symptoms in dementia
1.2. 4 hours of training for primary care psychiatrists on causes and medical treatment of neuropsychiatric symptoms in dementia
1.3. 15 minute individual occupational therapy sessions twice a week
1.4. Provision of and training in standardized assessments of neuropsychiatric symptoms in dementia (nursing staff)
2. Control centres: treatment as usual

The total duration of the intervention and follow up will be 9 months
Primary outcome measure(s) 1. Agitation as measured with the Cohen-Mansfield Agitation inventory (CMAI)
2. Depression as measured with the Dementia Mood Assessment Scale (DMAS)
3. Apathy as measured with the Apathy Evaluation Scale (AES)
All primary outcomes are measured at baseline and at 12 months.
Secondary outcome measure(s) 1. Psychotropic medication in defined daily dosages
2. Number of hospital admissions
3. Caregiver burden as measured with the Perceived Stress Scale (PSS)
4. Mortality
All secondary outcomes are measured at baseline, months 3, 6, and 12, and mortality dates are ascertained retrospectively.
Sources of funding German Federal Ministry of Health (Bundesministerium für Gesundheit [BMG]) (ref: LT 44-076)
Trial website
Publications 2008 protocol in: http://www.psycontent.com/content/18245348011151k2 (in German)
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23827658
Contact name Dr  Michael  Rapp
  Address Psychiatric University Hospital St. Hedwig
Grosse Hamburger Str. 5-11
  City/town Berlin
  Zip/Postcode 10115
  Country Germany
  Tel +49 2311 2057
  Fax +49 2311 2929
  Email michael.rapp@charite.de
Sponsor Federal Office of Administration (Bundesverwaltungsamt [BVA]) (Germany)
  Address Eupener Str. 125
  City/town Koeln
  Zip/Postcode 50728
  Country Germany
  Sponsor website: http://www.bundesverwaltungsamt.de
Date applied 30/01/2010
Last edited 25/04/2014
Date ISRCTN assigned 10/06/2010
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