Condition category
Mental and Behavioural Disorders
Date applied
20/04/2007
Date assigned
11/06/2007
Last edited
25/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.alz.co.uk/1066

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

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 Specified

Drug names

Primary outcome measures

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

01/06/2007

Overall trial end date

01/06/2008

Reason abandoned

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)

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

01/06/2007

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Mexico

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 Professor 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

Alzheimers Association (USA)

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

Study protocol: http://www.biomedcentral.com/1471-2458/7/165/abstract

Publication citations

Additional files

Editorial Notes