Contact information
Type
Scientific
Primary contact
Dr Michael Rapp
ORCID ID
Contact details
Psychiatric University Hospital St. Hedwig
Grosse Hamburger Str. 5-11
Berlin
10115
Germany
+49 2311 2057
michael.rapp@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LT 44-076
Study information
Scientific title
Evaluation of a combined guideline implementation protocol for neuropsychiatric symptoms in nursing home residents suffering from dementia
Acronym
VIDEANT
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet (in German)
Condition
Neuropsychiatric symptoms in dementia
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/11/2008
Overall trial end date
01/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Both male and female dementia patients aged 60 or older who live in a nursing home
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
400 (from 18 Berlin nursing homes)
Participant 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)
Recruitment start date
01/11/2008
Recruitment end date
01/05/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Psychiatric University Hospital St. Hedwig
Berlin
10115
Germany
Sponsor information
Organisation
Federal Office of Administration (Bundesverwaltungsamt [BVA]) (Germany)
Sponsor details
Eupener Str. 125
Koeln
50728
Germany
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Health (Bundesministerium für Gesundheit [BMG]) (ref: LT 44-076)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 protocol in: http://www.psycontent.com/content/18245348011151k2 (in German)
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23827658
Publication citations
-
Results
Rapp MA, Mell T, Majic T, Treusch Y, Nordheim J, Niemann-Mirmehdi M, Gutzmann H, Heinz A, Agitation in nursing home residents with dementia (VIDEANT trial): effects of a cluster-randomized, controlled, guideline implementation trial., J Am Med Dir Assoc, 2013, 14, 9, 690-695, doi: 10.1016/j.jamda.2013.05.017.