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

BackgroundPeer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design.DesignA 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness.DiscussionThe methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches.Trial RegistrationISRCTN37956201

[1]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance , 2008, BMJ : British Medical Journal.

[2]  Housing Lin,et al.  Living Well with Dementia: A National Dementia Strategy , 2009 .

[3]  D. Roth,et al.  Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease , 2006, Neurology.

[4]  L. Burgio,et al.  Resources for Enhancing Alzheimer's Caregiver Health (REACH): overview, site-specific outcomes, and future directions. , 2003, The Gerontologist.

[5]  D. Watson,et al.  Development and validation of brief measures of positive and negative affect: the PANAS scales. , 1988, Journal of personality and social psychology.

[6]  C. P. Hughes,et al.  A New Clinical Scale for the Staging of Dementia , 1982, British Journal of Psychiatry.

[7]  B. Winblad,et al.  A comparative study of the social conditions of spouses of long term patients cared for either in nursing homes or home care. , 1992, Scandinavian journal of caring sciences.

[8]  A. Kasuya EuroQol--a new facility for the measurement of health-related quality of life. , 1990, Health policy.

[9]  M. Mega,et al.  The Neuropsychiatric Inventory , 1994, Neurology.

[10]  R. Snaith,et al.  Doctors and overpopulation , 1986 .

[11]  C. Keyes,et al.  The structure of psychological well-being revisited. , 1995, Journal of personality and social psychology.

[12]  R. Schulz,et al.  Prevalence and impact of caregiving: a detailed comparison between dementia and nondementia caregivers. , 1999, The Gerontologist.

[13]  References , 1971 .

[14]  C. Heaney Support networks of older people: A guide for practitioners: By G. Clare Wenger. University of Wales, Bangor, 1994. 106pp, £6 (soft) , 1995 .

[15]  Martin Knapp,et al.  Costing psychiatric interventions. , 1992 .

[16]  C. Dennis,et al.  Peer support within a health care context: a concept analysis. , 2003, International journal of nursing studies.

[17]  L. Curtis,et al.  Unit Costs of Health and Social Care 2016 , 2015 .

[18]  Uk Beam Trial Team,et al.  United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care , 2004, BMJ : British Medical Journal.

[19]  G. Lamura,et al.  The COPE index--a first stage assessment of negative impact, positive value and quality of support of caregiving in informal carers of older people , 2003, Aging & mental health.

[20]  Rose-Marie Dröes,et al.  Effects of combined intervention programmes for people with dementia living at home and their caregivers: a systematic review , 2007, International journal of geriatric psychiatry.

[21]  Crispin Jenkinson,et al.  Development and Testing of the UK SF-12 , 1997 .

[22]  J. Rabe-Jabłońska,et al.  [Affective disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association -- diagnostic and statistical manual of mental disorders]. , 1993, Psychiatria polska.

[23]  M Knapp,et al.  Measurement of health-related quality of life for people with dementia: development of a new instrument (DEMQOL) and an evaluation of current methodology. , 2005, Health technology assessment.

[24]  M. Mugford,et al.  Befriending carers of people with dementia: randomised controlled trial , 2008, BMJ : British Medical Journal.

[25]  J. Burleson,et al.  Spouse caregivers of Alzheimer patients: problem responses to caregiver burden , 2006, Aging & mental health.

[26]  S. Folstein,et al.  "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. , 1975, Journal of psychiatric research.

[27]  K. Lichstein,et al.  Fair tests of clinical trials: A treatment implementation model , 1994 .

[28]  P. Bower,et al.  Effects of befriending on depressive symptoms and distress: systematic review and meta-analysis , 2010, British Journal of Psychiatry.

[29]  D. Moher,et al.  CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials , 2010, BMJ : British Medical Journal.

[30]  Henry Brodaty,et al.  Meta‐Analysis of Psychosocial Interventions for Caregivers of People with Dementia , 2003, Journal of the American Geriatrics Society.

[31]  J. Ware,et al.  A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. , 1996, Medical care.

[32]  M. Orrell,et al.  Quality of life in dementia: care recipient and caregiver perceptions of quality of life in dementia: the LASER‐AD study , 2007, International journal of geriatric psychiatry.

[33]  M. Sano,et al.  An Inventory to Assess Activities of Daily Living for Clinical Trials in Alzheimer's Disease , 1997, Alzheimer disease and associated disorders.

[34]  W. Stroebe,et al.  The role of loneliness and social support in adjustment to loss: a test of attachment versus stress theory. , 1996, Journal of personality and social psychology.

[35]  J. Ware,et al.  User’s manual for the SF-12v2 Health Survey (with a supplement Documenting SF-12 Health Survey) , 2007 .

[36]  C. Brewin,et al.  Measuring mental health needs , 1992 .

[37]  M. Mugford,et al.  Befriending carers of people with dementia: a cost utility analysis , 2009, International journal of geriatric psychiatry.

[38]  M. Patterson,et al.  Predictors of successful relationships in a peer support program for Alzheimer's caregivers , 2003, American journal of Alzheimer's disease and other dementias.

[39]  Masami Nishishiba,et al.  Understanding the relative importance of positive and negative social exchanges: examining specific domains and appraisals. , 2005, The journals of gerontology. Series B, Psychological sciences and social sciences.

[40]  R. Snaith,et al.  The Hospital Anxiety and Depression Scale , 1983 .

[41]  M. Mugford,et al.  Does befriending by trained lay workers improve psychological well-being and quality of life for carers of people with dementia, and at what cost? A randomised controlled trial. , 2008, Health technology assessment.

[42]  C. Browning,et al.  Challenges of recruitment and retention of older people from culturally diverse communities in research , 2008, Ageing and Society.

[43]  Martin Orrell,et al.  Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocol , 2009, Trials.

[44]  A. Williams EuroQol : a new facility for the measurement of health-related quality of life , 1990 .

[45]  A. Bandura,et al.  The revised scale for caregiving self-efficacy: reliability and validity studies. , 2002, The journals of gerontology. Series B, Psychological sciences and social sciences.

[46]  R Philip Snaith The Hospital Anxiety And Depression Scale , 1986, British medical journal.

[47]  Laura E. Gibbons,et al.  Assessing Quality of Life in Older Adults With Cognitive Impairment , 2002, Psychosomatic medicine.

[48]  D. Moher,et al.  Improving the reporting of pragmatic trials: an extension of the CONSORT statement , 2008, BMJ : British Medical Journal.

[49]  C. Carver You want to measure coping but your protocol’ too long: Consider the brief cope , 1997, International journal of behavioral medicine.

[50]  Barbara Gandek,et al.  Sf-12v2 How to score version 2 of the sf-12 health survey. Quality Metric Incorporated , 2002 .

[51]  E. Bruce,et al.  Remembering Yesterday, Caring Today: Reminiscence in Dementia Care: A Guide to Good Practice , 2008 .

[52]  G. Storms,et al.  The quality of the caregiving relationship in informal care for older adults with dementia and chronic psychiatric patients. , 2002, Psychology and psychotherapy.