Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7
Study information
Scientific title
A randomised controlled trial to assess the impact that dementia advisors have on the quality of life of people with dementia
Acronym
DAPE
Study hypothesis
A dementia advisor program will improve the overall quality of life for individuals with dementia and carers as compare to information provision service without a dementia advisor.
Ethics approval
Not provided at time of registration
Study design
Parallel group randomised pragmatic cluster controlled trial
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 use the contact details below to request a patient information sheet
Condition
Dementia
Intervention
As of 09/02/2010 the status of this record was updated as this trial never started due to pragmatic difficulties combining the delivery service and the research assessments.
The aim of the DAPE trial is to evaluate the impact on quality of life for a person with dementia of accessing a Dementia Adviser programme compared to a standardised information pack. The trial will also provide robust evidence on whether this dementia adviser model facilitates earlier diagnosis for people with dementia and improved access to services. These are key measures that have a long-term impact on the quality of life for a person with dementia. The third element of this trial will be to provide evidence of the financial impact of the Dementia Adviser programme for the NHS, social services and society. These findings will be vital in influencing changes in policy and practice relating to services for people with dementia.
In order to meet the above detailed objectives a parallel group, randomised, pragmatic cluster trial will be conducted to evaluate the efficacy of the dementia advisor program in comparison to information provision alone. Twenty sites throughout England will be randomised to either receive the Dementia Advisor Service or to receive information provision alone. Consecutive people with dementia referred to each site will be invited to participate in the clinical trial until 35 participants have been enrolled into the study at that site. It is anticipated that it will take 3 - 4 months to recruit the 35 participants at each individual site.
Participating sites will be randomised by the trial statistics team. Each cluster (site) will be randomised to receive either;
1. The Dementia Advisor Service
2. Information only
Therefore all participants at a particular site will receive either 1 or 2 depending of which one they have been allocated to. The randomisation will be computer generated using stratified block randomisation (fixed blocks size of 2) using Stata v8 software.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Dementia Quality of Life (DEMQOL), which is considered the most sensitive measure currently available to measure quality of life in people with dementia. Assessments will be done at baseline and 12 months.
Secondary outcome measures
Assessments will be done at baseline and 12 months:
1. The Quality of Life in Alzheimer's Disease (QOL-AD)
2. The Cornell Scale for Depression in Dementia (CSDD)
3. General Health Questionnaire-12 (GHQ-12)
4. Service Use and Cost Effectiveness: Modified Client Service Receipt Inventory
Overall trial start date
15/09/2009
Overall trial end date
15/09/2013
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Individuals with a diagnosis of dementia made by their primary care physician or a specialist clinician (no age range although most participants will be over 60 years, either sex)
2. Individuals referred for a specialist assessment with a likely diagnosis of dementia
3. Individuals referred to the Dementia Advisor Programme
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
700
Participant exclusion criteria
1. Individuals who do not have significant cognitive impairment
2. Individuals with a diagnosis of mild cognitive impairment given by either their primary care physician or specialist clinician
3. Individuals who are not likely to receive a diagnosis of dementia within the next 6 months
Recruitment start date
15/09/2009
Recruitment end date
15/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Kingns College London
London
SE1 1UL
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
c/o Keith Brennan
Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 1UL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Alzheimer's Society (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
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