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

• Register: ISRCTN
• Last refreshed on: 21 January 2020
• Main ID: ISRCTN41039907
• Date of registration: 11/06/2007
• Prospective Registration: No
• Primary sponsor: 10/66 Dementia Research Group (UK)
• Public title: 10/66 Dementia Research Group randomised controlled trial: helping carers to care - Russia
• Scientific title: 10/66 Dementia Research Group randomised controlled trial: helping carers to care - Russia
• Date of first enrolment: 05/04/2004
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN41039907
• Study type: Interventional
• Study design: Randomised single-blind placebo-controlled cross-over study (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Russian Federation

Contacts

• Name: Martin Prince

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Dementia syndrome
Mental and Behavioural Disorders
Dementia

Intervention(s)

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(s)

Caregiver psychological distress (SRQ-20) which is assessed at baseline and after six months.

Secondary Outcome(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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

World Health Organization (WHO) (Switzerland)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/12/2005