Welcome
Support Centre
26 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
10/66 Dementia Research Group randomised controlled trial: helping carers to care - Russia
ISRCTN ISRCTN41039907
DOI 10.1186/ISRCTN41039907
ClinicalTrials.gov identifier
EudraCT number
Public title 10/66 Dementia Research Group randomised controlled trial: helping carers to care - Russia
Scientific title
Acronym 10/66 Dementia Caregiver Intervention
Serial number at source N/A
Study hypothesis The primary hypothesis is that an intervention focusing upon education and training of caregivers (10/66 intervention) will be associated with a reduction in caregiver psychological strain (the 20-item Self-Reporting Questionnaire [SRQ-20] score). We further hypothesise that the intervention will be associated with an improvement in the quality of life of both caregivers and people with dementia, and in the distress experienced by caregivers arising from behavioural and psychological symptoms in the person with dementia.
Lay summary
Ethics approval The study has been approved by:
1. The Institute of Psychiatry Ethical Committee, King's College London in April 2003 (ref: 076/03)
2. The Ethical committee of the Mental Health Research Centre of the Russian Academy of Medical Sciences in October 2003
Study design Randomised single-blind placebo-controlled cross-over study
Countries of recruitment Russian Federation
Disease/condition/study domain Dementia syndrome
Participants - inclusion criteria 1. Aged 65 years and over
2. Meet Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for dementia syndrome
Participants - exclusion criteria 1. Serious intercurrent illness (e.g. terminal illness) in the person with dementia, where the intervention might seem pointless to the family
2. A complete absence of family caregivers
Anticipated start date 05/04/2004
Anticipated end date 30/12/2005
Status of trial Completed
Patient information material
Target number of participants 60 participants (30 in each arm)
Interventions 60 caregivers of people with dementia in each centre were randomised to receive the intervention immediately (n = 30) or six months later (n = 30). The 10/66 intervention targets the main carer, but includes members of the immediate and extended family. The aim is to provide basic education about dementia and specific training on managing problem behaviours. The three simple, manualised modules are delivered over five, weekly, half hour sessions.

1. Module one: assessment (one session):
1.1. Cognitive/functional impairment
1.2. Carer's knowledge and understanding of dementia
1.3. Care arrangements:
1.3.1. Who are the family members?
1.3.2. Who lives with the person with dementia?
1.3.3. How do they assist the main carer?
1.3.4. Which behavioural problems present most difficulties?
1.3.5. How burdened do they feel?

2. Module two: basic education (two sessions):
2.1. General introduction to the illness
2.2. What to expect in the future
2.3. What causes/does not cause dementia?
2.4. Locally available care and treatment

3. Module three: training on problem behaviours (two sessions): up to eight problem behaviours identified in the assessment are addressed:
3.1. Personal hygiene
3.2. Dressing incontinence
3.3. Repeated questioning
3.4. Clinging
3.5. Aggression
3.6. Wandering
3.7. Apathy
Primary outcome measure(s) Caregiver psychological distress (SRQ-20) which is assessed at baseline and after six months.
Secondary outcome measure(s) 1. Caregiver:
1.1. Zarit Burden Interview
1.2. Quality of Life, measured with the World Health Organisation Quality of Life Assessment (WHO-QoL BREF)
2. Person with dementia:
2.1. Behavioural and Psychological symptoms (Neuropsychiatric Inventory Questionnaire [NPI-Q])
2.2. Quality of life, measured using the Dementia Quality Of Life instrument (DEMQOL)

All secondary outcomes will be measured at baseline and six months.
Sources of funding World Health Organization (WHO) (Switzerland)
Trial website http://www.alz.co.uk/1066
Publications Study protocol: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=17659078
Contact name Prof  Martin  Prince
  Address Health Services and Population Research Department
Section of Epidemiology, P060
Institute of Psychiatry
De Crespigny Park
Denmark Hill
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Tel +44 (0)20 7848 0137
  Fax +44 (0)20 7277 0283
  Email m.prince@iop.kcl.ac.uk
Sponsor 10/66 Dementia Research Group (UK)
  Address c/o Prof Martin Prince
Health Services and Population Research Department
Section of Epidemiology, P060
Institute of Psychiatry
De Crespigny Park
Denmark Hill
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Tel +44 (0)20 7848 0137
  Fax +44 (0)20 7277 0283
  Email m.prince@iop.kcl.ac.uk
  Sponsor website: http://www.iop.kcl.ac.uk/iopweb/departments/home/default.aspx?locator=403
Date applied 20/04/2007
Last edited 10/09/2007
Date ISRCTN assigned 11/06/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.