Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Martin Orrell


Contact details

Department of Mental Health Sciences (Bloomsbury Campus)
University College London
67-73 Riding House Street
1st Floor
Charles Bell House
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

SHIELD Carer Supporter Programme: a peer support intervention for newer family carers of people with dementia



Study hypothesis

SHIELD Carer Supporter Programme (CSP) alone or in combination with reminiscence group work will be more effective in improving quality of life, effect, and self-efficacy of family carers than treatment as usual.

Ethics approval

Outer North East London Research Ethics Committee (REC), 11/06/2009, ref: 09/H0701/54

Study design

Multicentre single-blind randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

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




Three intervention conditions and one control condition are evaluated. These are:
1. SHIELD Carer Supporter Programme (CSP)
2. Remembering Yesterday, Caring Today (RYCT) group reminiscence work
4. Treatment as Usual (TAU)

The aim of the SHIELD CSP intervention is to improve a sense of self-efficacy/competence in the early stage carer through encouragement and positive reinforcement of carer skills development and carer network building activities. The Carer Supporters will be recruited through the voluntary sector by the Carer Supporter Manager based at Age Concern Havering, and will be supported by local Carer Supporter Coordinators based in voluntary organisations at each research site. Once recruited and trained, Carer Supporters will be matched with newer family carers through the voluntary sector. The SHIELD CSP intervention will involve weekly contact between a research participant and a more experienced carer (Carer Supporter) over a 3-month period. In this time, Carer Supporters may meet with the carers alone or jointly with the carer and relative with dementia. They may also attend support groups, educational meeting sor social gatherings with the matched newer carer. The Carer Supporter will not meet with the PwD in the absence of the carer. Ongoing contact between the Carer Supporter and early stage carer will be encouraged with a target of a fortnightly meeting, supported and monitored for a further 7 months.

The aim of the RYCT intervention is to improve the relationship and communication between the carer and PwD. This is achieved through the carer and PwD attending a weekly Remembering Yesterday Caring Today (RYCT) Reminiscence group over a 3-month period. The RYCT uses memory triggers (photographs, recordings, artefacts, etc.) to promote personal and shared memories. Groups of approximately 12 pairs are facilitated by a worker with experience in reminiscence work and running active or arts groups, and are supported by a team of paid staff and volunteers drawn from health, social services and the voluntary sector. After the initial 3 months of the RYCT intervention, participants are encouraged to take part in 'reunion' meetings at monthly intervals.

The aim of the SHIELD CSP/RYCT intervention is to combine the essential elements of the SHIELD CSP and RYCT interventions, and to extend the benefits of RYCT through bringing knowledge of the care dyad to the group, and taking knowledge of reminiscence into the carer's home. As such, it will involve both attendance at the RYCT group intervention and contact with a more experienced carer (Carer Supporter). The newer carer will have weekly contact with the Carer Supporter for at least 1 month prior to attending a 12-week RYCT group. During the RYCT group programme, Carer Supporters will be encouraged to attend as a part of the reminiscence team in place of other health, social care or voluntary sector personnel. After the RYCT group programme is complete, carers will be in contact with the Carer Supporters on a fortnightly basis, including attendance at the monthly RYCT 'reunions'.

NB. All participants, including those in the intervention groups, will continue to receive treatment as usual from statutory and voluntary services in their locality.

Treatment as Usual:
Participants randomised to the control group will continue to receive treatment as usual.

Baseline assessments will be carried out pre-randomisation. After this, two follow up assessments will be carried out at 5 months and 12 months after baseline. It is anticipated that participants will be involved in the intervention for a total of 12 months.

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Quality of life
2. Self-efficacy

Measured at baseline pre-randomisation, then at 2 follow ups: + 5 months from randomisation and +12 months randomisation.

Secondary outcome measures

1. Relationship quality
2. Anxiety and depression
3. Social Support
4. Hospitalisation/institutionalisation

Measured at baseline pre-randomisation, then at 2 follow ups: + 5 months from randomisation and +12 months randomisation.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. English-speaking family caregivers aged 18 years or over, either sex
2. Identified by themselves as a carer for person with a primary progressive cognitive impairment/dementia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for dementia including Alzheimer's, vascular dementia, dementia of Lewy Body type, and mixed dementias
3. Both the family carers and the person with dementia live within the areas covered by the research

Participant type


Age group




Target number of participants

300 family carer/person with dementia dyads

Participant exclusion criteria

1. Carers of people who are living in Residential, Nursing or long-stay hospital accommodation on a permanent basis
2. Carers of people with: congenital cognitive impairments (e.g. Down's syndrome); acquired non-progressive brain injury; cognitive impairments in the context of longstanding psychiatric illness e.g. schizophrenia
3. 'Carers' with significant congenital or acquired cognitive impairment, or where cognitive deficits are suspected in the carer
4. Family members with whom the suspected diagnosis of dementia has not been disclosed/discussed
5. Seriously ill carers, e.g. those receiving hospice or hospital treatment for terminal illness
6. Carers unable to take part in an intervention of 10 months duration
7. Carer unwilling for their person they care for to be approached
8. Non-family, paid carers
9. Either party already taking part in a psychosocial research study

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London
United Kingdom

Sponsor information


North East London NHS Foundation Trust (UK)

Sponsor details

Research and Development department
Maggie Lilley Suite
Goodmayes Hospital
Barley Lane
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1083)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2011 protocol in:
2016 results in:

Publication citations

  1. Protocol

    Charlesworth G, Burnell K, Beecham J, Hoare Z, Hoe J, Wenborn J, Knapp M, Russell I, Woods B, Orrell M, Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial., Trials, 2011, 12, 205, doi: 10.1186/1745-6215-12-205.

  2. Results

    Charlesworth G, Burnell K, Crellin N, Hoare Z, Hoe J, Knapp M, Russell I, Wenborn J, Woods B, Orrell M, Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial, J Neurol Neurosurg Psychiatry, 2016, pii: jnnp-2016-313736, doi: 10.1136/jnnp-2016-313736.

Additional files

Editorial Notes

22/08/2016: Publication reference added.