Condition category
Mental and Behavioural Disorders
Date applied
30/01/2010
Date assigned
10/06/2010
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.bundesverwaltungsamt.de

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

Results - basic reporting

Publication summary

2008 protocol in: http://www.psycontent.com/content/18245348011151k2 (in German)
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23827658

Publication citations

  1. 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.

Additional files

Editorial Notes