10/66 Dementia Research Group randomised controlled trial: helping carers to care - Russia
| ISRCTN | ISRCTN41039907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41039907 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/04/2007
- Registration date
- 11/06/2007
- Last edited
- 10/01/2020
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Prince
Scientific
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 |
|---|---|
| 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 - Russia |
| 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 | 05/04/2004 |
| Completion date | 30/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 60 participants (30 in each arm) |
| Total final enrolment | 60 |
| 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 | 05/04/2004 |
| Date of final enrolment | 30/12/2005 |
Locations
Countries of recruitment
- England
- Russian Federation
- United Kingdom
Study participating centre
Health Services and Population Research Department
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
10/66 Dementia Research Group (UK)
Research organisation
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 |
|---|---|
| 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
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
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: | 20/07/2007 | Yes | No | |
| Results article | results | 01/04/2009 | 10/01/2020 | Yes | No |
Editorial Notes
10/01/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
06/11/2019: Internal review.
