Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
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. People are now living longer, meaning that dementia represents a significant public health and care challenge. About 60% of people with dementia live in their own homes but finding the best ways of helping them to live well at home and supporting their carers is a challenge. Although more innovative home support services, from the NHS, social care and voluntary organisations exist in some areas, they are often underdeveloped. The study will be for those in early stage dementia, receiving care through memory clinics. The aim of this study is to evaluate the effectiveness of memory aids (a tool used to trigger memory), delivered by Dementia Support Practitioners (DSPs).

Who can participate?
Adults aged 50 years and over with early stage dementia who are under the care of a participating memory clinic or equivalent.

What does the study involve?
Practices are randomly allocated to one of two groups. Those in the first group receive specialist advice, information and memory aids from DSPs, as well as usual care from the memory clinic or equivalent that they attend. The memory aids pack includes a calendar or clock, whiteboard with electric time, and ‘post-it’ note dispenser. Those in the second group receive usual care from memory clinics with a general guide to dementia for patients and carers. Participants and their carers are visited at the start of the study and then three and 12 months later to be interviewed about their opinions, quality of life and use of services in order to establish the effectiveness of the DSP program.

What are the possible benefits and risks of participating?
Participants may or may not benefit from participating in the treatment from the DSP. If participants are not chosen to take part in the treatment, there may be no direct benefits from taking part in the study. However, the information participants provide will help to strengthen the evidence for developing more appropriate support at home for those in early stage dementia. There are no notable risks involved with participating in this study.

Where is the study run from?
Nine Memory clinics or Older Adult Services in England (UK)

When is the study starting and how long is it expected to run for?
July 2015 to September 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Paul Clarkson

Trial website

Contact information



Primary contact

Dr Paul Clarkson


Contact details

2nd Floor
Crawford House
University of Manchester
M13 9PL
United Kingdom
+44 161 275 5674

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effective home support in dementia care: Project 2.1 dementia early stage cognitive aids new trial



Study hypothesis

The aim of this study is to evaluate whether memory aids, delivered by Dementia Support Practitioners (DSPs), are effective and cost-effective.

Ethics approval

North West - Haydock Research Ethics Committee, 20/06/2016, ref: 16/NW/0389

Study design

Randomised; Interventional; Design type: Treatment, Process of Care, Device, Rehabilitation

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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


Randomisation will take place after baseline interviews with consented participants but before data entry in MACRO4, the data entry database used in the study. On receiving completed screening forms and baseline interview schedules, the Trial Manager will complete a randomisation request form and email this to the Trials Unit (Swansea Trials Unit - STU). The participant will then be randomised by the Assistant Trial Manager at STU who will email the Trial Manager with a PDF with details of the allocation. Participants will be allocated on a 1:1 basis into Intervention: Dementia Support Practitioner – DSP or Comparator: Treatment As Usual – TAU without DSP.

Comparator: Participants will receive a general guide to dementia for patients and carers as well as treatment as usual (TAU) in the form of support from their carers with or without help from memory clinic staff, post-diagnostic counselling and advice, and specialist follow-up.

Intervention: Dementia Support Practitioners (DSPs) will augment TAU with specialist advice, information and memory aids. They will dispense appropriate aids; and provide training in using these aids and general advice about improving memory. Their standard pack of memory aids will include: calendar or clock, whiteboard with electric time, and ‘post-it’ note dispenser, with a budget of £150 per participant. Support and follow-up will seek to ensure correct use of the aids. DSPs will work alongside any existing support and offer the memory aids in addition. The total duration of treatment will be 4 weeks.

For participants in both groups, follow up will be at 3 and 12 months after baseline (referral from memory clinic).

Intervention type



Drug names

Primary outcome measures

Activities of Daily Living (ADLs) are measured using the Bristol Activities of Daily Living Scale (BADLS) at baseline, 3, and 12 months.

Secondary outcome measures

1. Cognitive function measured using the Standardised Mini-Mental State Examination (S-MMSE) at baseline, 3, and 12 months
2. Quality of life measured using DEMQOL and DEMQOL-PROXY (carer rated) at baseline, 3, and 12 months
3. Health status measured using the EQ-5D-5L at baseline, 3, and 12 months
4. Service receipt measured using the Client Service Receipt Inventory and the Resource Utilisation in Dementia (RUD) at baseline, 3, and 12 months
5. Minor psychiatric morbidity in carers measured using the General Health Questionnaire (GHQ-12) at baseline, 3, and 12 months
6. Carer coping measured using the Short Sense of Competence Questionnaire (SSCQ) at baseline, 3, and 12 months
7. Carer rating of patients’ performance of activities measured using the Revised Interview for Deterioration in Daily living activities in Dementia (R-IDDD) at baseline, 3, and 12 months
8. Patient quality of life measured using the ICECAP-O and CASP-19 at baseline, 3, and 12 months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Participants with dementia:
1. Aged 50 years or older
2. Under care of one of the trial memory clinics or equivalent
3. Within one year of their first attendance at that clinic
4. Dementia is of mild to moderate severity
5. Physically able to engage with the intervention, usually as judged by researcher
6. Clinically able to engage with the intervention, usually as judged by responsible clinician
7. Living in their own home, or sharing a home with relative (i.e. not in residential or nursing home at baseline)

The primary person who feels responsible for, and supports, the person with dementia. They may be any age and may live with the person with dementia or independently.

Participant type


Age group




Target number of participants

Planned Sample Size: 360; UK Sample Size: 360

Participant exclusion criteria

Participants with dementia:
1. Individuals who are under 50 years of age
2. Advanced dementia, e.g. in late stages
3. Resident outside local authority boundary served by the service
4. Those currently undergoing emergency treatment or care

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Stockport Memory Service
The Meadows Owens Farm Drive
United Kingdom

Trial participating centre

Tameside Memory Service
Etherow Building Tameside Hospital Fountain Street
Ashton under Lyne
United Kingdom

Trial participating centre

Oldham Memory Service
Forrest House Royal Oldham Hospital Westhulme Avenue
United Kingdom

Trial participating centre

Rochdale Memory Service
Watergrove Day Hospital Birch Hill Hospital Union Road
OL12 9QB
United Kingdom

Trial participating centre

Bury Memory Service
The Ribchester Centre
United Kingdom

Trial participating centre

Havering Older Adults Services
Victoria Centre Pettits Lane
United Kingdom

Trial participating centre

Barking and Dagenham Older Adults Services
Broad Street Health Centre Morland Road
RM10 9HU
United Kingdom

Trial participating centre

Waltham Forest Memory Service
Red Oak Lodge Leytonstone
E11 4HU
United Kingdom

Trial participating centre

Redbridge Older Adults Services
Older Adult Mental Health Team Goodmayes Hospital Barley Lane
United Kingdom

Sponsor information


The University of Manchester

Sponsor details

Faculty of Medical & Human Sciences
Room 3.53 Simon Building
Brunswick Street
M13 9PL
United Kingdom
+44 161 275 5436

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

The findings of this trial will inform the case for structured support to patients diagnosed with early-stage dementia and their carers. It is therefore planned to present findings to professionals who care for dementia; and to submit them for publication in high-impact medical journals and specialist mental health journals. If the trial is successful, the study team intends to develop a toolkit to inform commissioners, managers and practitioners in late 2018.

Intention to publish date


Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes