Condition category
Mental and Behavioural Disorders
Date applied
04/09/2017
Date assigned
12/09/2017
Last edited
12/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Individual Cognitive Stimulation Therapy (CST) is a treatment for dementia that involves the individual with dementia taking part in activities such as a life story, discussion of current affairs, puzzles and being creative, which is designed to be mentally stimulating. There is evidence that group CST is effective in improving cognition in people with dementia in the general population. CST is now widely available for people with dementia in the general population but it is not routinely used in people with dementia who have learning disabilities. Sometimes it may be less appropriate to provide group based CST, for example in individuals who have mobility or behavioural problems. For these individuals, individual CST may be an alternative option. Individual CST involves a carer carrying out activities with the individual with dementia using a manual. However, there have been few studies of individual CST in the general population and they have shown mixed results in improving cognition. People with intellectual disabilities may find it more difficult to take part in group CST because the needs and abilities differ greatly between individuals and they are more likely to have visual and hearing problems that could make participating in a group more challenging. At the moment there is very little evidence for the use of CST in people with dementia and intellectual disabilities. The aim of this study is to find out whether the treatment is feasible and acceptable to individuals with dementia and their carers to see if it is carry out a larger study in the future to find out if the treatment is effective in improving cognition and quality of life.

Who can participate?
Adults aged 40 and older who have a diagnosis of intellectual disabilities and dementia.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive their usual care. Those in the second group receive the iCST programme as well as the usual care. All the participants have access to the care that they normally receive, which may include anti-dementia medication and visits to see their psychiatrist or nurse. In the intervention group, the carers of the participants will deliver a programme of activities designed to keep the brain active. The programme runs for 20 weeks, with the carer delivering two 30 minute sessions a week. Participants are assessed on their cognition, quality of life and functional ability. Carers are assessed on the amount of time spent caregiving, the burden they feel and their levels of anxiety and depression.

What are the possible benefits and risks of participating?
By participating, it may slow the rate at which memory or other cognitive functions decline in dementia. There are no direct risks from taking part in the study.

Where is the study run from?
This study is being run by the University of London (UK) and takes place in 6 trusts in the UK.

When is the study starting and how long is it expected to run for?
January 2014 to June 2019

Who is funding the study?
Baily Thomas Charitable Fund (UK)

Who is the main contact?
Dr Afia Ali
afia.ali@ucl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Afia Ali

ORCID ID

http://orcid.org/0000-0002-0104-9370

Contact details

6th Floor
Maple House
UCL
149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33410

Study information

Scientific title

Feasibility randomised controlled trial of individual Cognitive Stimulation Therapy (iCST) for dementia in people with Intellectual disability

Acronym

Study hypothesis

The aim of this study is to carry out a feasibility randomised controlled trial to determine the tolerability and acceptability of the intervention, individual Cognitive Stimulation Therapy (iCST), delivered to people with intellectual disability and dementia.

Ethics approval

Harrow Research Ethics Committee, 20/03/2017, ref: 17/LO/0030

Study design

Randomised; Both; Design type: Treatment, Screening, Diagnosis, Complex Intervention, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Please use the contact details below to request a patient information sheet

Condition

Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system

Intervention

Participants are randomly assigned to the intervention or control arm using a web based system called Sealed Envelope. Those in the control arm with receive treatment as usual. Those in the intervention arm receive a manualised programme of cognitive activities delivered by their carer twice a week for 20 weeks. Carers are trained in the delivery of the manual. Once the intervention and outcome measures have been completed, those in the control arm are offered the manual and training on how to use it if they wish.

Participants are assessed on their cognition, quality of life and functional ability. Carers are assessed on the amount of time spent caregiving, the burden they feel and their levels of anxiety and depression. These assessments are completed before the intervention, halfway through and when it has finished. The control group are offered access to the iCST manual and training at the end of the study.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Participant’s cognitive functioning will be measured using the CAMCOG-DS at baseline, 11 weeks and 21 weeks.

Secondary outcome measures

1. Participants cognitive functioning is measured using the Modified Memory for Objects test from the Neuropsychological Assessment of Dementia in Intellectual Disabilities Battery at baseline, 11 weeks and 21 weeks, and the Cognitive Scale for Down Syndrome (CS-DS) at baseline, 11 weeks and 21 weeks.
2. Functional ability is measured using ADCS- Activities of Daily Living Inventory (ADCS-ADL) at baseline, 11 weeks and 21 weeks
3. Participant’s health related quality of life is measured using the DEMQOL-proxy at baseline, 11 weeks and 21 weeks
4. Care giver burden is measured using the Care Giving Burden Scale at baseline, 11 weeks and 21 weeks
5. Time spent caring for the participant with dementia will be measured using the Care Giver Activity Survey-Intellectual Disability (CAS-ID) at baseline, 11 weeks and 21 weeks
6. Carer anxiety and depression is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 11 weeks and 21 weeks

Overall trial start date

01/01/2014

Overall trial end date

30/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of mild- moderate intellectual disability
2. Diagnosis of mild- moderate dementia
3. Aged 40 years old or above
4. Suitable verbal communication in English
5. No significant visual or hearing impairment
6. No significant physical illness, physical disability or behavioural problems that would affect participation
7. A willing carer available to deliver the intervention

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 111; UK Sample Size: 111

Participant exclusion criteria

1. Severe intellectual disability
2. Late stage dementia
3. Significant hearing or visual impairment
4. Unable to speak English
5. No carer willing to participate in the study

Recruitment start date

01/12/2017

Recruitment end date

31/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Waltham Forest Learning Disability Service (Lead centre)
30 Coleridge Road Walthamstow
London
E17 6QU
United Kingdom

Trial participating centre

Barking and Dagenham Learning Disability Service
Civic Centre Rainham Road North Dagenham
London
RM10 7BN
United Kingdom

Trial participating centre

Community Learning Disability Team - Havering
The Hermitage Billet Lane
Hornchurch
RM11 1XL
United Kingdom

Trial participating centre

Community Learning Disability Team - Redbridge
852 Cranbrook Road Illford
London
IG6 1HZ
United Kingdom

Trial participating centre

Camden Learning Disability Service
Camden Town Hall Judd Street
London
WC1H 9JE
United Kingdom

Trial participating centre

Islington learning Disability Service
52D Drayton Park Islington
London
N5 1NS
United Kingdom

Trial participating centre

Tower Hamlets Learning Disability Service
Beaumont House Mile End Hospital Bancroft Road
London
E1 4DG
United Kingdom

Trial participating centre

Newham Learning Disability Service
29 Romford Road Stratford
London
E15 4LY
United Kingdom

Trial participating centre

Hackney Learning Disability Service
Hackney Service Centre 1 Hillman Street
London
E8 1DY
United Kingdom

Trial participating centre

Haringey Learning Disabilities Partnership
River Park House 225 High Road Wood Green
London
N22 8HQ
United Kingdom

Trial participating centre

Barnet Learning Disability Service
Building 4 North London business Park Oakleigh Road South
London
N11 1NP
United Kingdom

Trial participating centre

Enfield Learning Disability Service
St Andrew's Court 1-4 River Front Enfield
London
EN1 3SY
United Kingdom

Trial participating centre

Westminster Learning Disability Partnership
215 Lisson Grove
London
NW8 8LF
United Kingdom

Trial participating centre

Kensington and Chelsea Learning Disability Service
1-9 St Mark's Road
London
W11 1RG
United Kingdom

Trial participating centre

Forston Clinic
Dorset Healthcare University NHS Foundation Trust# Herrison Road
Dorchester
DT2 9TB
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
1st Floor Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Baily Thomas Charitable Fund

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal and findings presented at conferences.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes