Cognitive stimulation therapy in people with intellectual disability and dementia
| ISRCTN | ISRCTN18312288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18312288 |
| Secondary identifying numbers | 33410 |
- Submission date
- 04/09/2017
- Registration date
- 12/09/2017
- Last edited
- 20/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 their competence to look after someone with dementia, the burden of looking after someone with dementia 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
Contact information
Public
6th Floor, Maple House
UCL
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
 ORCID ID |
0000-0002-0104-9370 |
|---|
Study information
| Study design | Randomised; Both; Design type: Treatment, Screening, Diagnosis, Complex Intervention, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Please use the contact details below to request a patient information sheet |
| Scientific title | Feasibility randomised controlled trial of individual Cognitive Stimulation Therapy (iCST) for dementia in people with intellectual disability |
| Study objectives | 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(s) | Harrow Research Ethics Committee, 20/03/2017, ref: 17/LO/0030 |
| Health condition(s) or problem(s) studied | Dementia in people with an intellectual disability |
| 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 |
| Primary outcome measure | Participant’s cognitive functioning will be measured using the CAMCOG-DS at baseline, 11 weeks and 21 weeks. |
| Secondary outcome measures | Current secondary outcome measures as of 03/08/2018: 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 QOL-AD proxy at baseline, 11 weeks and 21 weeks 4. Caregiver burden is measured using the Care Giving Burden Scale at baseline, 11 weeks and 21 weeks 5. Competence to look after someone with dementia will be assessed using the Sense of Competence in Dementia Care Staff (SCIDS) scale 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 Previous 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. Caregiver 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 study start date | 01/01/2014 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 111; UK Sample Size: 111. This includes 40 dyads (40 participants with intellectual disability and 40 carers). |
| Total final enrolment | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2017 |
| Date of final enrolment | 31/03/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Walthamstow
London
E17 6QU
United Kingdom
Rainham Road North
Dagenham
London
RM10 7BN
United Kingdom
Billet Lane
Hornchurch
RM11 1XL
United Kingdom
Illford
London
IG6 1HZ
United Kingdom
Judd Street
London
WC1H 9JE
United Kingdom
Islington
London
N5 1NS
United Kingdom
Mile End Hospital Bancroft Road
London
E1 4DG
United Kingdom
Stratford
London
E15 4LY
United Kingdom
1 Hillman Street
London
E8 1DY
United Kingdom
225 High Road
Wood Green
London
N22 8HQ
United Kingdom
North London business Park
Oakleigh Road South
London
N11 1NP
United Kingdom
1-4 River Front
Enfield
London
EN1 3SY
United Kingdom
London
NW8 8LF
United Kingdom
London
W11 1RG
United Kingdom
Herrison Road
Dorchester
DT2 9TB
United Kingdom
Sponsor information
University/education
Joint Research Office
1st Floor Maple House
149 Tottenham Court Road
London
W1T 7NF
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Baily Thomas Charitable Fund
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 02/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal and findings presented at conferences. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V3 | 10/03/2017 | 12/09/2017 | No | No |
| Protocol file | version V5 | 14/02/2018 | 06/08/2018 | No | No |
| Protocol article | protocol | 09/12/2018 | 18/12/2019 | Yes | No |
| Results article | 04/01/2021 | 20/12/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN18312288_PROTOCOL_V3_10Mar2017.pdf
- Uploaded Protocol Version 3 10 March 2017 on 12/09/2017
- ISRCTN18312288_PROTOCOL_V5_14Feb2018.pdf
- Uploaded 06/08/2018
Editorial Notes
20/12/2021: Publication reference added.
29/10/2020: The following changes have been made:
1. The intention to publish date has been changed from 31/07/2019 to 02/01/2021.
2. The Participant inclusion criteria: Target number of participants has been changed from "Planned Sample Size: 111; UK Sample Size: 111.)" to "Planned Sample Size: 111; UK Sample Size: 111. This includes 40 dyads (40 participants with intellectual disability and 40 carers).".
18/12/2019: Publication reference added.
03/04/2019: The condition has been changed from "Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system" to "Dementia" following a request from the NIHR.
06/08/2018: Uploaded protocol Version 5, 14 February 2018 (not peer reviewed).
03/08/2018: The secondary outcome measures were updated.
26/10/2017: Internal review.
12/09/2017: Uploaded protocol Version 3, 10 March 2017 (not peer reviewed).
