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

Charlesworth, Georgina; Burnell, Karen; Beecham, Jennifer; Hoare, Zoë; Hoe, Juanita; Wenborn, Jennifer; Knapp, Martín; Russell, Ian; Woods, Bob; Orrell, Martin

doi:10.1186/1745-6215-12-205

Cited by 20 publications

(24 citation statements)

References 40 publications

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“…The trial protocol6 describes the research question, sample size calculation, recruitment, consent, randomisation, interventions, outcome measures, ethical considerations and research governance.…”

Section: Methodsmentioning

confidence: 99%

Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial

Charlesworth¹,

Burnell

Crellin

et al. 2016

J Neurol Neurosurg Psychiatry

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107

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ObjectiveThe objective of this study was to evaluate peer support and reminiscence therapy, separately and together, in comparison with usual care for people with dementia and their family carers.DesignFactorial pragmatic randomised trial, analysed by treatment allocated, was used for this study.SettingThe trial ran in Community settings in England.ParticipantsPeople with dementia and their family carers were the participants.InterventionsTreatment as usual (TAU) plus one of the following: one-to-one peer support to family carers from experienced carers (Carer Supporter Programme; CSP), group reminiscence therapy (Remembering Yesterday, Caring Today; RYCT) for people with dementia and carers, both or neither.Main outcome measuresPrimary outcomes included health-related quality of life (SF-12) for carers and quality of life (QoL-AD) for people with dementia; secondary outcomes included quality of relationship for carers and people with dementia; both were collected by blinded assessors at baseline, 5 and 12 months (primary end point).ResultsOf 291 pairs recruited, we randomised 145 (50%) to CSP (71% uptake) and 194 (67%) to RYCT (61% uptake). CSP and RYCT, separately or together, were not effective in improving primary outcomes or most secondary outcomes. For CSP versus ‘no CSP’, adjusted difference in means was 0.52 points on the SF-12 (95% CI −1.28 to 2.32) and −0.08 points on the QoL-AD (95% CI −1.70 to 1.56). For RYCT versus ‘no RYCT’, the difference was 0.10 points on the SF-12 (95% CI −1.72 to 1.93) and 0.51 points on the QoL-AD (95% CI −1.17 to 2.08). However, carers reported better relationships with the people with dementia (difference 1.11, 95% CI 0.00 to 2.21, p=0.05). Comparison of combined intervention with TAU, and of intervention received, suggested differential impacts for carers and persons with dementia.ConclusionsThere is no evidence from the trial that either peer support or reminiscence is effective in improving the quality of life.Trial registration numberISRCTN37956201; Results.

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Section: Methodsmentioning

confidence: 99%

Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial

Charlesworth¹,

Burnell

Crellin

et al. 2016

J Neurol Neurosurg Psychiatry

Self Cite

107

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“…This is currently under way, through the National Institute of Health Research (NIHR)-funded Support at Home -Interventions to Enhance Life in Dementia Programme 'SHIELD' (principal investigator: Professor Martin Orrell, University College London ), in which joint reminiscence groups are being compared with a caregiver support programme, based on the Befriending and Costs of Caring (BECCA) intervention, evaluated in a previous HTA trial. [65][66][67] The second relates to the effects of reminiscence groups for people with dementia alone. This was considered in the trial platform for REMCARE, in which outcomes appeared similar whether or not caregivers were included.…”

Section: Recommendations For Future Researchmentioning

confidence: 99%

REMCARE: reminiscence groups for people with dementia and their family caregivers – effectiveness and cost-effectiveness pragmatic multicentre randomised trial

Woods

Bruce²,

Edwards³

et al. 2012

Health Technol Assess

114

194

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How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address.Paying by credit card You can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume.How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. NIHR Health Technology Assessment programmeThe Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service' . The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. Fi...

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“…3) Based on the draft checklist we planned and tested methods of monitoring, and recorded outcomes of monitoring, for a pilot trial of psychological interventions for family carers of people with dementia [17]. We gathered evidence on design, methods and procedures from research participants, research staff, the providers of interventions (both experimental and control) and recipients of those interventions.…”

Section: Introductionmentioning

confidence: 99%

“…The trial compares four interventions: one-to-one peer support for family carers of people with dementia (CSP); large group reminiscence therapy for people with dementia and their family carers (Remembering Yesterday Caring Today – RYCT); CSP and RYCT in combination; and treatment as usual – neither CSP nor RYCT [17]. …”

Section: Introductionmentioning

confidence: 99%

Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

Charlesworth

Burnell

Hoe

et al. 2013

BMC Med Res Methodol

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Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity is key, greater flexibility is written into trial protocols to allow for ‘real life’ variation in procedures. We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity. We illustrate the use of the checklist using a pragmatic trial of psychosocial interventions for family carers of people with dementia as a case study.

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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

Cited by 20 publications

References 40 publications

Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial

Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial

REMCARE: reminiscence groups for people with dementia and their family caregivers – effectiveness and cost-effectiveness pragmatic multicentre randomised trial

Acceptance checklist for clinical effectiveness pilot trials: a systematic approach

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