The DAPE study: the impact of dementia advisors on the quality of life of dementia sufferers

ISRCTN	ISRCTN33790007
DOI	https://doi.org/10.1186/ISRCTN33790007
Secondary identifying numbers	7

Submission date: 08/08/2009
Registration date: 14/10/2009
Last edited: 09/02/2010

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Clive Ballard
Scientific

Kingns College London
Wolfson Centre for Age-Related Diseases
Guy's Campus
London
SE1 1UL
United Kingdom

Study information

Study design	Parallel group randomised pragmatic cluster controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial to assess the impact that dementia advisors have on the quality of life of people with dementia
Study acronym	DAPE
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	15/09/2009
Completion date	15/09/2013
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	700
Key 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
Key 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
Date of first enrolment	15/09/2009
Date of final enrolment	15/09/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Kingns College London

London
SE1 1UL
United Kingdom

Sponsor information

King's College London (UK)
University/education

c/o Keith Brennan
Room 1.8, Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom

Website	http://www.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

Alzheimer's Society (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): alzheimerssoc
Location: United Kingdom

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