Condition category
Mental and Behavioural Disorders
Date applied
11/10/2012
Date assigned
16/10/2012
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 Alzheimer’s 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

Contact information

Type

Scientific

Primary contact

Mrs Aleksandra Kudlicka

ORCID ID

Contact details

Trial Manager
Bangor University
School of Psychology
Bangor
LL57 2AS
United Kingdom

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 June 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 measures

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

Eligibility

Participant inclusion criteria

1. The participant must have an ICD-10 diagnosis of Alzheimer’s 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

Trial Manager
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

http://www.bangor.ac.uk/psychology

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

Results - basic reporting

Publication summary

1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23710796

Publication citations

  1. 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.

Additional files

Editorial Notes