Condition category
Mental and Behavioural Disorders
Date applied
08/08/2009
Date assigned
14/10/2009
Last edited
09/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Clive Ballard

ORCID ID

Contact details

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

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 measures

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

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

Kingn’s 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

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

Alzheimer's Society (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes