Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RP-PG-0606-1083
Study information
Scientific title
SHIELD Carer Supporter Programme: a peer support intervention for newer family carers of people with dementia
Acronym
SHIELD CSP
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
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
Condition
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
Phase
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
01/07/2009
Overall trial end date
30/09/2012
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
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
01/07/2009
Recruitment end date
30/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
W1W 7EJ
United Kingdom
Sponsor information
Organisation
North East London NHS Foundation Trust (UK)
Sponsor details
Research and Development department
Maggie Lilley Suite
Goodmayes Hospital
Barley Lane
Ilford
IG3 8XJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
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
Location
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: http://www.ncbi.nlm.nih.gov/pubmed/21917187
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27521377
Publication citations
-
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.
-
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.