Kalra, L., Evans, A., Perez, I., Melbourn, A., Patel, A., Knapp, M., & Donaldson, N., (2004). Training caregivers of stroke patients: randomised controlled trial. BMJ, 328, 1099-1103.
Summary of aims and results
Kalra et al., (2004) acknowledge that rehabilitation of stroke patients has been found to effectively reduce severe disability and that this has translated into an increased amount of patients with residual disability being cared for in the home. They therefore aimed to investigate whether providing training in such skills as lifting, positioning, continence, etc., along with advice on communication techniques, would reduce caregiver burden and contribute to the improvement of both patient and caregiver outcomes (Kalra et al., 2004). A randomised controlled trial of 300 stroke patients and their care givers was conducted to test this hypothesis. The experimental group received 3 to 5 hospital based training sessions with an additional ‘follow-through’ home session (Kalra et al., 2004). The control group received only standard care. Results of assessments carried out at 3 and 12 months post intervention indicated that patients whose care givers participated in the training reported significantly improved quality of life and mood scores (Kalra et al., 2004). Significantly reduced burden of care and a significant improvement in quality of life at 3 and 12 months was also evidenced in the carers who had received the training (Kalra et al., 2004). Moreover, this reduction in depression and anxiety in the carers who had received the training was found to be independent of the degree of disability, severity of stroke, or age. However, there were no significant differences between groups in mortality, re-institutionalisation or functional abilities (Kalra et al., 2004).
A randomised controlled trial is deemed to be the most rigorous research design for establishing a cause – effect relationship between an intervention and outcome (Hicks, 2009) specifically due to the employment of a randomisation technique. In their trial, Kalra et al., (2004), adopted a block randomisation process to assign participants to either the conventional care group or the care giver training group. This ensured that the two resulting groups were similar in all respects, with the single difference being that one group would receive the care giver training and the other group would not. This controls for the effects of confounding variables and bias, as it is assumed that if present, these would be equally distributed among the groups (Field, 2009). Therefore, the resulting differences between groups can be assumed to be the outcome of the intervention. Additionally, this process ensures that an equal number of participants is allocated to each group (Field, 2009). A further methodological strength of the study is the measurement of baseline variables. Based on previous literature, Kalra et al., (2004) identified the patient and care giver variables which they considered to affect the outcome of the study including, patient demographics, stroke subtype, scores on the Barthel and Frenchay activity indexes, etc. This information identified the prognostic factors for the outcome (Hicks, 2009), which were subsequently inspected in pre-specified subgroup regression analysis. Essentially, baseline and post-intervention measures are compared to determine whether or not the intervention was effective and whether there is a significant difference between groups on these measures (Field, 2009). Thirdly, an important methodological strength of the study conducted by Kalra et al., (2004), is that the data was analysed on an intention – to –treat basis. The authors report that for patients who were lost to follow up, the last obtained data sets were included in analyses. This inclusion is important as individuals may drop out of a study because the intervention may have had an adverse...
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