Condition category
Mental and Behavioural Disorders
Date applied
26/11/2010
Date assigned
10/03/2011
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Orrell

ORCID ID

Contact details

North East London NHS Foundation Trust (NELFT)
R&D 1st Floor
Maggie Lilley Suite
Goodmayes Hospital
Ilford
Essex
IG3 8XJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An evaluation and comparison of the effectiveness of two different cognitive stimulation therapy (CST) approaches and their implementation in practice

Acronym

Study hypothesis

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

East London REC3 pending approval as of 26/11/2010

Study design

Multicentre randomised controlled trial with a monitoring trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2011

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant 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

Recruitment start date

01/02/2011

Recruitment end date

31/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North East London NHS Foundation Trust (NELFT)
Essex
IG3 8XJ
United Kingdom

Sponsor information

Organisation

North East London NHS Foundation Trust (NELFT) (UK)

Sponsor details

c/o John Brouder
Chief Executive
Goodmayes Hospital
Ilford
Essex
IG3 8XJ
United Kingdom

Sponsor type

Government

Website

http://www.nelft.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22735077

Publication citations

  1. Protocol

    Streater A, Spector A, Aguirre E, Hoe J, Hoare Z, Woods R, Russell I, Orrell M, Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial., Trials, 2012, 13, 91, doi: 10.1186/1745-6215-13-91.

Additional files

Editorial Notes

08/12/2015: Plain English summary added.