Contact information
Type
Scientific
Primary contact
Prof Martin Prince
ORCID ID
Contact details
Health Services and Population Research Department
Section of Epidemiology
P060
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0137
m.prince@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
10/66 Dementia Research Group randomised controlled trial: helping carers to care - Russia
Acronym
10/66 Dementia Caregiver Intervention
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Dementia syndrome
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Caregiver psychological distress (SRQ-20) which is assessed at baseline and after six months.
Secondary outcome measures
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.
Overall trial start date
05/04/2004
Overall trial end date
30/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
60 participants (30 in each arm)
Total final enrolment
60
Participant 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
Recruitment start date
05/04/2004
Recruitment end date
30/12/2005
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Health Services and Population Research Department
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
10/66 Dementia Research Group (UK)
Sponsor details
c/o Prof Martin Prince
Health Services and Population Research Department
Section of Epidemiology
P060
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0137
m.prince@iop.kcl.ac.uk
Sponsor type
Research organisation
Website
http://www.iop.kcl.ac.uk/iopweb/departments/home/default.aspx?locator=403
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
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
Study protocol: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=17659078
2009 results in https://www.ncbi.nlm.nih.gov/pubmed/18814197 (added 10/01/2020)
Publication citations
-
Study protocol
Prince M, Ferri CP, Acosta D, Albanese E, Arizaga R, Dewey M, Gavrilova SI, Guerra M, Huang Y, Jacob KS, Krishnamoorthy ES, McKeigue P, Rodriguez JL, Salas A, Sosa AL, Sousa RM, Stewart R, Uwakwe R, The protocols for the 10/66 dementia research group population-based research programme., BMC Public Health, 2007, 7, 165, doi: 10.1186/1471-2458-7-165.