10/66 Dementia Research Group randomised controlled trial: helping carers to care - Argentina

ISRCTN	ISRCTN95135433
DOI	https://doi.org/10.1186/ISRCTN95135433
Secondary identifying numbers	N/A

Submission date: 20/04/2007
Registration date: 11/06/2007
Last edited: 06/11/2019

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Martin Prince
Scientific

Health Services and Population Research Department
Section of Epidemiology, P060
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0137
Email	m.prince@iop.kcl.ac.uk

Study information

Study design	Randomised single-blind placebo-controlled cross-over study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title	10/66 Dementia Research Group randomised controlled trial: helping carers to care - Argentina
Study acronym	10/66 Dementia Caregiver Intervention
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2007
Completion date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	60 participants (30 in each arm)
Key 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
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	01/06/2008

Locations

Countries of recruitment

Argentina
England
United Kingdom

Study participating centre

Health Services and Population Research Department

London
SE5 8AF
United Kingdom

Sponsor information

10/66 Dementia Research Group (UK)
Research organisation

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

Phone	+44 (0)20 7848 0137
Email	m.prince@iop.kcl.ac.uk
Website	http://www.iop.kcl.ac.uk/iopweb/departments/home/default.aspx?locator=403
"ROR"	https://ror.org/04jmzkq74

Funders

Funder type

Research organisation

Alzheimers Association (USA)

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?
Protocol article	Study protocol:	01/12/2007		Yes	No

Editorial Notes

06/11/2019: Internal review.