SHIELD Carer Supporter Programme for family carers of people with dementia

ISRCTN	ISRCTN37956201
DOI	https://doi.org/10.1186/ISRCTN37956201
Secondary identifying numbers	RP-PG-0606-1083

Submission date: 15/06/2009
Registration date: 27/08/2009
Last edited: 22/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Martin Orrell
Scientific

Department of Mental Health Sciences (Bloomsbury Campus)
University College London
67-73 Riding House Street
1st Floor, Charles Bell House
London
W1W 7EJ
United Kingdom

Study information

Study design	Multicentre single-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	SHIELD Carer Supporter Programme: a peer support intervention for newer family carers of people with dementia
Study acronym	SHIELD CSP
Study objectives	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(s)	Outer North East London Research Ethics Committee (REC), 11/06/2009, ref: 09/H0701/54
Health condition(s) or problem(s) studied	Dementia
Intervention	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 3. Combined SHIELD CSP/RYCT 4. Treatment as Usual (TAU) SHIELD CSP: 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. RYCT: 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. Combined SHIELD CSP/RYCT: 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	Other
Primary outcome measure	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 study start date	01/07/2009
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300 family carer/person with dementia dyads
Key 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
Key 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
Date of first enrolment	01/07/2009
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London

London
W1W 7EJ
United Kingdom

Sponsor information

North East London NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development department
Maggie Lilley Suite
Goodmayes Hospital
Barley Lane
Ilford
IG3 8XJ
England
United Kingdom

Website	http://www.nelmht.nhs.uk/
"ROR"	https://ror.org/023e5m798

Funders

Funder type

Government

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

No information available

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	15/09/2011		Yes	No
Results article	results	01/11/2016		Yes	No

Editorial Notes

22/08/2016: Publication reference added.