From rehabilitation to recovery: protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke

Inroads in the efficacy of acute stroke management have resulted in reduced mortality rates and morbidity from the event of stroke. However, stroke remains a leading cause of death, and the rise in life expectancy of the Australian population (with the proportion of the population aged over 65 years having considerably increased) has resulted in a higher prevalence of stroke, with an estimated 60 000 events occurring per year [1, 2]. About 320 000 people (aged between 16-85 years) had suffered a stroke in 2007 in Australia, with a large subset (42.5%) reporting a disability that resulted in ongoing activity restriction [2]. Disability caused by stroke has enduring social and economic consequences, in part due to the burden on the healthcare system and the dependency on carers for physical and financial assistance [3]. It is important to continue to address the management of the sequelae of stroke, not just in the acute and immediate sub-acute settings, but into the longer-term chronic phase. There is a need to determine and develop strategies that may facilitate longer term outcomes and maximise an individual's capabilities.

Early post-stroke rehabilitation tends to focus on the amelioration of impairments and activity restrictions, so that basic mobility and self-care tasks can be achieved. Upon returning to the community, further sub-acute rehabilitation resources may be required to maximise recovery and prevent deterioration [4, 5]. Surprisingly, research on the most effective way to further assist the patient and their carers to re-establish their lives in the community during the first year after stroke, especially with regard to the resumption of valued activities, is scant. Most people who have had a stroke display ongoing activity limitations (such as problems with basic self-care tasks and mobility), and also a resultant negative impact on domestic and community-based activities [3]. There can also be alterations in participation levels, health-related quality of life (HRQoL), and mood status. Variables such as these may reflect the concept of adaptive functioning, and can provide an important gauge of an individual's perception of their current situation [6].

Alteration in mood status, particularly in the form of emerging depression, is a common problem post-stroke. It is estimated that a third of people who have had a stroke will display post-stroke depression (PSD) [7]. Depression is characterised by persistent low mood (of a duration greater than two weeks), often with addition symptoms of: alterations to weight or appetite; disturbed sleep patterns; loss of energy; sense of worthlessness; suicidal ideation; anhedonia; psychomotor retardation and/or agitation. PSD has not only been associated with a diminished re-uptake of previously valued activities, but a reduced perception of HRQoL [8, 9]. Thus, there is the need for interventions aimed at not only improving physical impairment and disability, but also addressing mood status, participation, and HRQoL [8]. This was highlighted in a recent systematic review which found that rehabilitation therapies, conducted in patients' community context, which endeavoured to frame the intervention to target patients' valued activities (such as leisure pursuits), showed moderate evidence for improvement in global participation measures and HRQoL [10].

Participation status can also be markedly affected post-stroke, with mobility problems and the presence of depressive symptoms being particularly predictive of adversely altering participation levels [11, 12]. Participation, in this context, relates to a person's ability to engage in life situations [13]. This concept also encompasses aspects of personal and social re-integration, and a return to valued and meaningful activities [14]. Valued activities are an individual phenomenon, and may relate to life aspects such as: domestic, family, and social roles; employment; hobbies, socialising; and sporting pursuits [15]. Resumption of previously valued activities may also have an impact on an individual's sense of life quality [8, 15]. The perception of HRQoL is generally reported to be reduced post-stroke [16, 17]. The concept of HRQoL tries to capture how an individual views the impact of their health status on their quality of life, especially in relation to physical, cognitive, and emotional factors. Presence of depressed mood, low functional activity status, and lack of social support are predictors of HRQoL post-stroke [18, 19]. However, a study by Sturm et al. (2004) ascertained that a significant number of people who have had a stroke report a diminished HRQoL despite an overall good functional recovery [8].

Central to the aim of the post-stroke rehabilitation process should be a client-centred framework that adopts a goal-setting model. Meaningful, collaborative goal-setting is an acknowledged essential part of rehabilitation practice [14]. Endorsement of goal-directed behaviour (by the patient, support network, and rehabilitation services) is an important element for ongoing recovery and overall adjustment to post-stroke abilities [20]. In addition, the process of goal setting may assist to reduce carer anxiety and offer active problem-solving coping strategies [21]. The need to provide long-term care for the person who has had a stroke can place carers under considerable emotional, financial, and physical stress [22]. To date, many interventions aimed at reducing the negative impacts of caring have shown minimal effect, and there is a requirement for a heightened understanding of the relationships between patient and carer characteristics, and overall carer outcomes [23]. Awareness of the impact of the broader social context, and in particular consideration of psychosocial factors (such as carer involvement and their emotional well-being) on rehabilitation outcomes is required. Carers can facilitate the recovery process, and their inclusion in the overall rehabilitation model is essential. In shifting to a rehabilitation paradigm that is consumer and carer-directed, there may also emerge a shift from a model based on clinician-driven rehabilitation programs to one that primarily aims to achieve patient-centred recovery.

The issues that are faced by the person who has had a stroke, and their family and carers, in the first year post-stroke are multifactorial and complex. The relationship that has been established in the literature between mood status, participation level, and HRQoL post-stroke warrants further investigation. The exploration of an integrated, goal-oriented approach (utilising activities that the patient nominates as important to their notion of recovery) is the basis of the intervention framework in this randomised controlled trial. The additional effect of such an intervention on the primary carer will also be investigated.

The objectives of the study are to:

This paper provides a detailed description of the methodology of this post-stroke interventional study, based on the following hypotheses:

This is a single blind randomised controlled trial of a multifaceted, client-centred intervention for post-stroke management.

The recommendation for healthcare clinicians to incorporate a client-centred approach to the rehabilitation process is well entrenched in guidelines for stroke rehabilitation and current policy trends [44]. However the adoption of such practice is variable, and many goals of stroke rehabilitation remain clinician-directed and focused on basic mobility and self-care activities. There is a distinct need for a wider adoption of patient-determined goals to adequately focus on activities that have intrinsic meaning for the individual. It is hoped that such a shift in focus will produce more favourable outcomes with regards to mood status, participation levels, and perception of health-related quality of life. The additional involvement of carers as 'partners' in the rehabilitation process may also lead to favourable patient outcomes, as well as lessening the emergence of adverse carer outcomes. The goal of this study is to investigate whether offering an integrated intervention to facilitate goal achievement is more effective for these outcomes than usual care.

There are many complexities that arise when performing research on a community-based post-stroke cohort. In this trial there will inevitably be variation between patients with regards to the time from stroke event to baseline data collection (discharge from inpatient rehabilitation). The other formal assessments are taken at a fixed time post-stroke (six and twelve months). The intervention for this study is essentially non-standardised, making description of the protocol challenging. Its operation is based on emerging 'flags' that activate consideration of a relevant intervention to address the identified situation. However, a distinct advantage of such a protocol is that it enables the intervention to be responsive and based on individualised needs. There is evidence to support the adoption of community-based interventions that endeavour to take into account the valued activities of the person who has had a stroke [10]. The effect of the event of a stroke on mood status, participation levels, and health-related quality of life are well documented. The interest should now shift to how to best intervene to positively alter these outcomes, for both the stroke patient and their carer.

If the intervention in this study is shown to be of benefit to both the patient and carer, it would provide the basis for a model of community-based rehabilitation management for people who have had a stroke and their carers, that adopts a robust client-centred approach. This model could conceivably be implemented within the current sub-acute rehabilitation services framework, without need for extensive additional resources.