Improving the treatment of neuropsychiatric symptoms in nursing home residents suffering from dementia

ISRCTN	ISRCTN43578978
DOI	https://doi.org/10.1186/ISRCTN43578978
Protocol serial number	LT 44-076
Sponsor	Federal Office of Administration (Bundesverwaltungsamt [BVA]) (Germany)
Funder	German Federal Ministry of Health (Bundesministerium für Gesundheit [BMG]) (ref: LT 44-076)

Submission date: 30/01/2010
Registration date: 10/06/2010
Last edited: 25/04/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Rapp
Scientific

Psychiatric University Hospital St. Hedwig
Grosse Hamburger Str. 5-11
Berlin
10115
Germany

Phone	+49 2311 2057
Email	michael.rapp@charite.de

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of a combined guideline implementation protocol for neuropsychiatric symptoms in nursing home residents suffering from dementia
Study acronym	VIDEANT
Study objectives	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(s)	Ethics Committee of Charite - University Medicine Berlin approved on the 17th of July 2008 (ref: EA1/065/08)
Health condition(s) or problem(s) studied	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
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.
Key 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.
Completion date	01/05/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	400
Key inclusion criteria	Both male and female dementia patients aged 60 or older who live in a nursing home
Key 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)
Date of first enrolment	01/11/2008
Date of final enrolment	01/05/2010

Locations

Countries of recruitment

Germany

Study participating centre

Psychiatric University Hospital St. Hedwig

Berlin
10115
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes