Living well with memory difficulties

ISRCTN	ISRCTN21027481
DOI	https://doi.org/10.1186/ISRCTN21027481
Secondary identifying numbers	11/15/04

Submission date: 11/10/2012
Registration date: 16/10/2012
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Aleksandra Kudlicka
Scientific

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

Study information

Study design	Multi-centre single blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format; please contact a.kudlicka@bangor.ac.uk to request a patient information sheet
Scientific title	Goal-oriented cognitive Rehabilitation in Early-stage Alzheimer's disease: multi-centre single-blind randomised controlled Trial (GREAT)
Study acronym	GREAT
Study objectives	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(s)	North Wales Research Ethics Committee, 25/06/2012, ref: 12/WA/0185
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2012
Completion date	31/01/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	480
Total final enrolment	475
Key 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
Key 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
Date of first enrolment	01/10/2012
Date of final enrolment	31/01/2017

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Bangor University

Bangor
LL57 2AS
United Kingdom

Sponsor information

Bangor University (UK)
University/education

School of Psychology
Bangor
LL57 2AS
Wales
United Kingdom

Website	http://www.bangor.ac.uk/psychology
"ROR"	https://ror.org/006jb1a24

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK) ref:11/15/04

No information available

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	27/05/2013		Yes	No
Results article		01/03/2019		Yes	No
Results article		01/03/2019	30/07/2021	Yes	No
Results article		26/10/2021	28/10/2021	Yes	No

Editorial Notes

25/10/2022: Internal review.
28/10/2021: Publication reference added.
05/08/2021: Internal review.
30/07/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
13/07/2021: Internal review.
19/03/2019: Publication reference added.
03/10/2018: No publications found, verifying study status with principal investigator.