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Data collection and analysis Two review authors selected studies for inclusion, independently extracted data and assessed methodological quality. We sought original data from trialists. We categorised interventions into three groups: support and information, teaching procedural knowledge/vocational training type interventions, and psycho-educational type interventions. The primary outcome was caregivers’ stress or strain. We resolved disagreements by consensus. Main results Eight studies, including a total of 1007 participants, met our inclusion criteria. We did not pool the results of all the studies because of substantial methodological, statistical and clinical heterogeneity. For caregivers’ stress or strain we found no significant results within categories of intervention, with the exception of one single-centre study examining the effects of a ’vocational training’ type intervention which found a mean difference between the intervention and comparator group at the end of scheduled follow-up of -8.67 (95% confidence interval -11.30 to -6.04, P < 0.001) in favour of the ’teaching procedural knowledge’ type intervention group. Authors’ conclusions It was not possible to carry out a meta-analysis of the evidence from RCTs because of methodological, clinical and statistical heterogeneity. One limitation across all studies was the lack of a description of important characteristics that define the informal caregiver population. However, ’vocational educational’ type interventions delivered to caregivers prior to the stroke survivor’s discharge from hospital appear to be the most promising intervention. However, this is based on the results from one, small, single-centre study. P L A I N L A N G U A G E S U M M A R Y Services to help people who look after or provide help and support to stroke survivors People who look after or provide help and support to stroke survivors have a very important part in the life of a stroke survivor. However, looking after or giving help and support to a stroke survivor can affect the health and well-being of the person who is the main carer. Therefore, it is important that health and social care professionals, policy makers and, more importantly, carers of stroke survivors and stroke survivors are aware of what educational, respite or other type of services might help carers. Based on the results of this review, which included eight studies involving 1007 participants, there is currently not enough information available to help us work out what services might be best for informal caregivers of stroke survivors. However, another 11 studies are currently underway, which may help us find out what works best. B A C K G R O U N D An informal caregiver (or unpaid caregiver) has been defined as “a person of any age who provides unpaid help and support to a relative, friend or neighbour who cannot manage to live independently without the carers help due to frailty, illness, disability or addiction” (SGHD 2005). Informal caregivers play an important and sizeable part in the total care provided to stroke survivors and often provide significant amounts of assistance with personal and instrumental activities of daily living: they monitor signs and symptoms and general health; store, control and appropriately administer medications; organise and co-ordinate care among health and social care providers; act as an advocate for the care recipient; and provide emotional and psychosocial support. Therefore, the care-giving scenario can be complex, demanding and challenging. Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Providing informal unpaid care, help or support to stroke survivors who live in the community can be burdensome (McCullagh 2005) and stressful (Smith 2003), and can have an adverse effect on the caregiver’s psychological well-being (Berg 2005; Kotila 1998) and physical health (Carnwath 1987). A range of healthcare interventions targeted towards stroke survivors and their family or other informal caregivers has been tested in randomised controlled trials (RCTs). The aim of this systematic review and meta-analysis was to determine more clearly the effects of interventions directed towards the informal caregiver, the care-giving working conditions (e.g. typical hours of care provided, flexibility, the nature of care-giving tasks performed, the physical environment, the physical, emotional and 2
mental demands, autonomy in decision-making, training opportunities, availability of professional support, etc) or interventions that target both caregiver and care-giving working conditions on a range of outcomes. Description of the condition An increasing number of studies have found an association between stress in informal caregivers and immune dysregulation (Gouin 2008), an increased risk of mortality (Schulz 1999), elevated blood pressure (King 1994), impaired wound healing (Kiecolt-Glaser 1995), increased risk of coronary heart disease (Lee 2003) and poorer cognitive function among women who provide care to their disabled or ill spouses (Lee 2004). The hypothesis is that when the demands placed on the informal caregiver are at variance with the needs, expectations and capacity of the caregiver, this stress can predispose the caregiver to ill health. Description of the intervention We are interested in any interventions targeted towards the caregiver or the care-giving working conditions, or interventions that target the combination of caregiver and care-giving working conditions. How the intervention might work These interventions might work to reduce the care-giving demands through: • changing the knowledge, beliefs, attitudes or behaviours of the caregiver; or • temporarily reducing or removing the caregiver’s responsibility for the stroke survivor; or • addressing ongoing psychological and social problems. Why it is important to do this review Given that caregivers provide a substantial amount of the overall care delivered to stroke survivors and are likely to be at risk of adverse health outcomes, it would be useful for healthcare professionals, informal caregivers, as well as those responsible for the disbursement of health and social care resources, to have easy access to this information to prevent further associated morbidity. Furthermore, aspects of the health of caregivers are addressed in several Cochrane Reviews (Ellis 2010; Smith 2008); however, the caregivers are not the primary focus of any review. O B J E C T I V E S The objective of this review was to provide the most reliable summary of the effect of interventions targeted towards informal caregivers of stroke survivors or targeted towards informal caregivers and the care recipient (the stroke survivor). The specific questions were as follows. 1. What are the effects of interventions targeted towards informal caregivers of stroke survivors? 2. Is the evidence of benefit greater in any pre-defined subgroup? M E T H O D S Criteria for considering studies for this review Types of studies Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. We sought all truly randomised controlled trials (RCT) of nonpharmacological interventions targeted towards informal caregivers of stroke survivors with the aim of either: changing knowledge, beliefs, attitude or behaviours of the informal caregiver, or temporarily reducing/removing the caregiver’s responsibility for the stroke survivor. We excluded studies which included stroke survivors and caregivers if the stroke survivors were the primary target of the intervention. Types of participants We included trials that recruited informal caregivers of stroke patients. A definition of an informal caregiver is ’a person of any age who provides one or more hours of unpaid help and support per week to a stroke survivor’. However, for the purpose of this review, we accepted the investigators’ definition. We excluded trials of mixed aetiology if the percentage of stroke patients was less than 80%. Types of interventions The review focused on trials of non-pharmacological interventions, compared with no care or routine care that has the following features: • delivered to an informal caregiver of a stroke survivor; • delivered to an informal caregiver and a stroke survivor as a dyad: that is, both informal caregiver and stroke survivor are randomised; and • where there is an intention to have an impact on caregivers’ knowledge, beliefs, attitude or behaviour. Trials of non-pharmacological interventions where there is an intention to reduce or remove the responsibility for care-giving, for 3
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