Improving the treatment of neuropsychiatric symptoms in nursing home residents suffering from dementia
| ISRCTN | ISRCTN43578978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43578978 |
| Secondary identifying numbers | 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
Scientific
Psychiatric University Hospital St. Hedwig
Grosse Hamburger Str. 5-11
Berlin
10115
Germany
| Phone | +49 2311 2057 |
|---|---|
| michael.rapp@charite.de |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet (in German) |
| 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 | 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 study start date | 01/11/2008 |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 400 (from 18 Berlin nursing homes) |
| 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
10115
Germany
Sponsor information
Federal Office of Administration (Bundesverwaltungsamt [BVA]) (Germany)
Government
Government
Eupener Str. 125
Koeln
50728
Germany
| Website | http://www.bundesverwaltungsamt.de |
|---|---|
"ROR" |
https://ror.org/04n9aye53 |
Funders
Funder type
Government
German Federal Ministry of Health (Bundesministerium für Gesundheit [BMG]) (ref: LT 44-076)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
