Plain English Summary
Background and study aims:
Early treatment offers the possibility of helping people with early-stage dementia (PwD) and their family members (carers) to manage the impact of the disease on everyday life, and reduce or delay the progression of disability. A new treatment called cognitive rehabilitation (CR), has been developed to meet this need. CR involves identifying realistic and achievable goals in the areas of everyday activity affected by changes in memory and other cognitive abilities, where the PwD wishes to see improvements. A therapist works with the PwD and carer on the priorities they have identified and helps to tackle the things that are most important to them and most likely to make a difference. This study aims to provide evidence about whether CR is a beneficial and cost-effective treatment for PwD and carers.
Who can participate?
Participants will be PwD diagnosed with early-stage Alzheimers disease (AD), vascular dementia, or mixed AD and vascular dementia. They will be recruited from memory clinics, old age mental health services and GP practices. For each participant, a carer will also be involved.
What does the study involve?
After initial assessment, PwD will be randomly assigned to receive either treatment as usual or to receive CR. The therapist will want to find out how memory difficulties are affecting the everyday life of the PwD and where they would like to see improvements, and will work with the patients to address these goals. CR will be conducted in participants homes. All participants will be re-assessed after 3 months and again 6 months later.
What are the possible benefits and risks of participating?
Participants may find it interesting and enjoyable to talk with the researcher and complete the questionnaires and tasks included in the study. The findings will be used to train staff working in Memory Clinics to improve the services they for people with early-stage dementia. We do not anticipate any risks associated with taking part in the study.
Where is the study run from?
Bangor University
When is study starting and how long is it expected to run for?
The study will start in October 2012 and run for 51 months.
Who is funding the study?
NIHR Health Technology Assessment Programme
Who is the main contact?
Aleksandra Kudlicka
a.kudlicka@bangor.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11/15/04
Study information
Scientific title
Goal-oriented cognitive Rehabilitation in Early-stage Alzheimer's disease: multi-centre single-blind randomised controlled Trial (GREAT)
Acronym
GREAT
Study hypothesis
To provide definitive evidence about whether goal-oriented cognitive rehabilitation (CR) is a clinically-effective and cost-effective intervention for people with early stage dementia and their family carers.
Ethics approval
North Wales Research Ethics Committee, 25/06/2012, ref: 12/WA/0185
Study design
Multi-centre single blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format; please contact a.kudlicka@bangor.ac.uk to request a patient information sheet
Condition
Dementia
Intervention
Participants will be randomised to either cognitive rehabilitation or treatment as usual. The cognitive rehabilitation intervention protocol will consist of 10 weekly sessions followed by 4 maintenance sessions spread over a 6 month period. Outcomes will be assessed at 3 and 9 months post randomisation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Bangor Goal-Setting Interview
Secondary outcome measures
For participants with dementia (PwPD)
1. DEMQOL
2. Generalized Self-Efficacy Scale (GSES)
3. Hospital Anxiety and Depression Scale (HADS)
4. Rivermead Behavioural Memory Test (RBMT) story recall sub-test
5. Test of Everyday Attention (TEA) elevator counting and elevator counting with distraction sub-tests
6. Delis-Kaplan Executive Function System (D-KEFS) letter fluency sub-test
7. Client Services Receipt Inventory (CSRI)
For carers:
1. Relatives' Stress Scale (RSS)
2. EuroQOL (EQ5D)
3. WHO Quality of Life BREF (WHOQOL-BREF)
Overall trial start date
01/10/2012
Overall trial end date
31/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The participant must have an ICD-10 diagnosis of Alzheimers disease (AD), vascular dementia, or mixed AD and vascular dementia
2. The participant must be in the early stages of dementia, as indicated by an MMSE score of 18 or above
3. If taking acetylcholinesterase inhibitors, the participant must have been receiving a stable dose for one month prior to trial entry, and there should be no intention to change the dose over the period of participation in the study unless clinically indicated
4. The participant must have a carer who is willing to participate
5. The participant must be able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
480
Participant exclusion criteria
1. Participants will be excluded if they have a prior history of stroke, brain injury or other significant neurological condition
2. Participants will be excluded if they are unable to speak English
Recruitment start date
01/10/2012
Recruitment end date
31/01/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bangor University
Bangor
LL57 2AS
United Kingdom
Sponsor information
Organisation
Bangor University (UK)
Sponsor details
School of Psychology
Bangor
LL57 2AS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK) ref:11/15/04
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23710796
Publication citations
-
Protocol
Clare L, Bayer A, Burns A, Corbett A, Jones R, Knapp M, Kopelman M, Kudlicka A, Leroi I, Oyebode J, Pool J, Woods B, Whitaker R, Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)., Trials, 2013, 14, 152, doi: 10.1186/1745-6215-14-152.