Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
85327
Study information
Scientific title
Development of an awareness-based intervention to enhance quality of life in severe dementia: a cluster randomised trial across 8 care homes
Acronym
Study hypothesis
Providing care staff with an observational tool that can help to identify evidence of awareness in residents with severe dementia, supported by appropriate training and supervision, will lead to improvements.
Ethics approval
North West Wales Research Ethics Committee approved on the 17th October 2008 (ref: 08/WNo01/60)
Study design
Cluster randomised trial of an observational measure of awareness
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please contact catherine.quinn@bangor.ac.uk to request a patient information sheet
Condition
Dementia
Intervention
Care staff in homes allocated to the intervention condition will be trained and mentored in using an observational measure of awareness with selected residents over an 8-week period.
The control group will consist of 4 care homes, which will be paired with 4 care homes receiving the intervention. Baseline assessments will be conducted at the control homes after which they will receive no additional input for the 8 week period in which other homes will be receiving the intervention.
Follow-up assessments will be conducted at both homes after the end of the intervention period.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Care staff:
1.1. Staff attitudes: Approaches to Dementia Questionnaire (ADQ)
1.2. Care practice: The Dementia Care Practitioner's Assessment (DCPA)
1.3. Well-being: Maslach Burnout Inventory (MBI); General Health Questionnaire (GHQ-12)
2. Assessment of the person with dementia:
2.1. Behaviour: Behavioural Assessment Scale Of Later Life (BASOLL)
2.2. Well-being: Positive Response Scale (PRS)
2.3. Quality of life: Quality of Life in Late-stage Dementia (QUAL-ID)
All measured at baseline and at the end of the 8 week intervention period.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2010
Overall trial end date
28/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Care staff:
1.1. Working in the identified homes
1.2. All ages, either sex
1.3. Permanent employees
1.4. Have been in post for at least six months
1.5. Work at least 15 hours per week
2. Individuals:
2.1. All ages, either sex
2.2. Severe dementia
2.3. Have no, or only very limited, verbal communication
Participant type
Patient
Age group
Other
Gender
Not Specified
Target number of participants
Up to 80 care staff, observing in total 80 residents with severe dementia
Participant exclusion criteria
1. Agency staff
2. Staff who are unable to communicate effectively in English
3. Individuals with dementia who are wholly or largely confined to bed
Recruitment start date
01/06/2010
Recruitment end date
28/02/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Psychology
Bangor
LL57 2AS
United Kingdom
Sponsor information
Organisation
Bangor University (UK)
Sponsor details
School of Psychology
Brigantia Building
Bangor University
Bangor
LL57 2AS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (ref: 85327)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20579370
2. 2012 results of tool development in https://www.ncbi.nlm.nih.gov/pubmed/22264147
3. 2013 results of RCT in https://www.ncbi.nlm.nih.gov/pubmed/22840185
Publication citations
-
Protocol
Clare L, Woods RT, Whitaker R, Wilson BA, Downs M, Development of an awareness-based intervention to enhance quality of life in severe dementia: trial platform., Trials, 2010, 11, 73, doi: 10.1186/1745-6215-11-73.