Implementation and evaluation of two different cognitive stimulation therapy training approaches
| ISRCTN | ISRCTN28793457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28793457 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/11/2010
- Registration date
- 10/03/2011
- Last edited
- 11/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Dementia is a common condition in the aging population. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worst over time (cognitive function). This can make it very difficult to deal with daily life and so many sufferers are eventually placed in nursing homes so that they can receive round-the-clock care. Cognitive Stimulation Therapy (CST) is a treatment for people suffering from mild to moderate dementia. CST involves group-sessions run by specially trained staff to help to stimulate and engage people with dementia, helping them to improve their memory and communication skills. The aim of this study is to look at the training and outreach support offered to staff providing CST, as well as the benefits to people with dementia who are taking part in CST groups.
Who can participate?
Adults with mild to moderate dementia and the staff members looking after them.
What does the study involve?
Staff members are randomly allocated to one of two groups. Participants in both groups receive their usual training, as well as the 1-day CST training, training DVD and two manuals containing information of training and maintaining the skills they learn. For those in the first group, outreach support is also provided, which consists of online forum, email support, telephone conferences and local supervision, available over 12 months. For those in the second group, no additional support is provided. At the start of the study, and then again after 6 and 12 months, participants in both groups complete three questionnaires designed to find out their thoughts on the programme, the knowledge they have gained, and if the training has changed the way they work. In a second aspect of the trial, the participants are contacted in order to find out whether staff members have been running the CST groups after purchasing the manual and/or attending the training day. For those who are given access to outreach support (providing extra support that is not usually offered), the amount that they have used it is recorded. In a third aspect of the trial, people with dementia who are taking part in the CST programme undergo additional tests to find out if the CST has had any effect on their cognitive function and quality of life.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
North East London NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2011 to August 2012
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Professor Martin Orrell
Contact information
Scientific
North East London NHS Foundation Trust (NELFT)
R&D 1st Floor
Maggie Lilley Suite
Goodmayes Hospital
Ilford
Essex
IG3 8XJ
United Kingdom
Study information
| Study design | Multicentre randomised controlled trial with a monitoring trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An evaluation and comparison of the effectiveness of two different cognitive stimulation therapy (CST) approaches and their implementation in practice |
| Study objectives | The level of adherence to cognitive stimulation therapy (CST) will increase in relation to the degree of support that the site receives. The null hypothesis is that training alone would not be sufficient knowledge to run groups. |
| Ethics approval(s) | East London REC3 pending approval as of 26/11/2010 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Randomised controlled trial (RCT): In the RCT all staff members will be expected to attend training and will receive two manuals, workbook and DVD. They will then be randomised to receive outreach support or no outreach support. The outreach support consists of online forum, email support, telephone conferences and local supervision, these will be offered over a twelve month period. All of the people with dementia will receive CST and maintenance CST therapy sessions and half of the people with dementia will be randomised to complete minimal outcome measures, relating to their cognition and quality of life. Monitoring trial: The members of staff will be recruited if they have independently bought the training manual and/or attended the training day. So this will not be offered to them. They will then be split in to which one they apply to and half from each group will be offered outreach support linked in to the RCT. All of the people with dementia will receive CST and maintenance CST therapy sessions and half of the people with dementia will be randomised to complete minimal outcome measures, relating to their cognition and quality of life. |
| Intervention type | Other |
| Primary outcome measure | 1. Number of attendees to the CST groups 2. Level of adherence 3. Competency of staff member For staff the measures will be completed at baseline, 6 and 12 months. For the people with dementia they will be measured at baseline, 7 and 31 weeks. |
| Secondary outcome measures | 1. Minimal outcome measures with person with dementia (cognition and quality of life) 2. Job satisfaction 3. Approaches to dementia 4. Dementia knowledge 5. Learning transfer system inventory 6. Barriers to change For staff the measures will be completed at baseline, 6 and 12 months. For the people with dementia they will be measured at baseline, 7 and 31 weeks. |
| Overall study start date | 01/02/2011 |
| Completion date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | Staff: 1. Staff members' working directly for people with dementia 2. Willingness to self complete three sets of questionnaires within a year time frame 3. Adequate written and spoken comprehension of the English language 4. Opportunity to recruit five to eight suitable people in the mild to moderate stages of dementia 5. Access to a computer and an adequate level of competency to complete questionnaires online 6. Each centre will contribute three or more staff members who will intend to run CST groups 7. Agreement with management to have two hours, set aside, each week to run CST sessions and one hour a week, set aside, for the following 24 weeks of maintenance CST groups Person with dementia: 1. Previous diagnosis of mild to moderate dementia, with a score of between 0.5 and 2 on the Clinical Dementia Rating 2. Adequate spoken and written English 3. Ability to participate in a 'meaningful' conversation 4. Good eyesight and hearing 5. Level of comprehension to willingly give informed consent to take part in groups 6. Ability to partake in a group for 45 minutes 7. Willingness to complete the QoL-AD and Mini-Mental State Examination (MMSE) at three intervals over a year time frame 8. Do not have a major physical illness or disability which could affect participation 9. Do not have a diagnosis of a learning disability Both: 10. Male and female, aged between 18 - 99 years |
| Key exclusion criteria | Staff: 1. Not having direct access to people with dementia 2. Not being able to recruit between five to eight people with dementia 3. Unable to complete self-completing questionnaires 4. Inability to access or use a computer 5. Unable to write or speak fluently in English 6. Inability to provide three staff members to take part in the the trial 7. No consent from management Person with dementia: 1. No diagnosis of dementia 2. Inability to write or speak fluently in English 3. Unable to enagage in a conversation 4. Unable to stay in a group for 45 minutes 5. Bad eyesight or hearing 6. Unable to give informed consent 7. Not willing to complete minimal outcome measures |
| Date of first enrolment | 01/02/2011 |
| Date of final enrolment | 31/08/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
IG3 8XJ
United Kingdom
Sponsor information
Hospital/treatment centre
c/o John Brouder, Chief Executive
Goodmayes Hospital
Ilford
Essex
IG3 8XJ
England
United Kingdom
| Website | http://www.nelft.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/023e5m798 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/06/2012 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No |
Editorial Notes
11/12/2018: Publication reference added.
08/12/2015: Plain English summary added.
