Discuss about the Randomised Control Trial for Dementia Patient.
Yes, the Randomized controlled trial (RCT) gave idea of a clearly focused issue on which the research was conducted. The aim of the research was to compare the effect of foot massage (intervention) and quiet presence (comparator and control) on agitation and mood in dementia patient (population) (Moyle et al. 2014).
Participants were randomized to treatment and control group. This can be understood by the review of method section of the article which explained that block randomization was used to achieve equality in the size of intervention and control groups. Allocation concealment was done by randomizing participants by a computer program. Allocation was concealed from data collection research assistants, care staffs and patient’s families (Moyle et al. 2014).
Yes, the patients were analyzed in the groups to which they were randomized. This is also understood because the trial was not stopped in between and all participants were followed up between baseline and post-test. No participants were lost to follow up after being randomized to treatment.
Yes, family’s health workers and study personnel were blinded to treatment. This is understood as Moyle et al. (2014) mentioned about care staffs, data collections research assistant and families in the section of randomization and blinding. The purpose of blinding in clinical trial is to eliminate any impact of study findings due to different expectation of staffs (Schulz et al. 2011). Treatment allocation is not revealed to many research staffs until they enter the trial to prevent selection bias and any uninfluenced in study results because of knowledge about concealment (Karanicolas, Farrokhyar and Bhandari 2010). Hence, it serves to prevent differential treatment of the group at the onset of trial.
The validity of any RCT study is understood by keeping the baseline variables same at the start of the trial (Piantadosi 2017). This is understood by reviewing the ‘result’ section of the stud which states that no difference in group at baseline were found for participants on the basis of age, gender, time spend in facility, living condition, regular medication and PNR medication for dementia patients. Example of baseline variables includes age, sex, social class, risk factors and other adverse outcomes in participant. The advantage of keeping groups similar at the start of the trial is that it helps to prevent baseline imbalance (Doig and Simpson 2014).
The unique feature of a RCT study is that it tries to study the effect of an intervention by randomization of participants to intervention and control group (Hayes and Moulton 2017). In such studies, the only different between the intervention group and control group is the intervention itself and other parameters are kept same (Latimer et al. 2017). In the RCT study by Moyle et al. (2014), intervention group received foot massage and control group received quiet presence. However, other things such as duration of session, time frame of giving intervention was kept same for the first treatment arm. As it used crossover study design, participants were exposed to opposite treatment arm after the completion of first treatment arm. The advantage of a cross-over design is that it reduces variability in participants as both types of treatment are compared on the same patient (Apiliogullari and Onal 2015).
The main purpose of the research study by Moyle et al. (2014) was to analyze the effect of foot massage in dementia patients compared to those with quite presence. The size of the treatment effect can be understood by the final outcome of the study. Both intervention and control groups were evaluated on the outcome measure of assessing agitation and mood of patients post the treatment. Agitation was assessed in participants by means of Cohen-Mansfield Agitation Inventory Short Form (CMAI) and mood was evaluated by observed emotion rating (OERS) scale. The validity of the RCT study is evident as the researcher also reported about the consistency and inter-reliability of both the tools. Detailed description of both the tools and the scale on which agitation and mood were evaluated was also comprehensively described by the researcher (Moyle et al. 2014).
The primary outcome of the study was that the study showed that increase in agitation was found in both group, however the effect was greater in the quiet presence group compared to treatment group. The main reason for increase in total CMAI was the increase in the subscale of verbal aggression. However, outcome remained same for OERS item and only difference was found in general alertness in both groups. Therefore, slight effect of intervention was found in foot massage group as had reduced alertness and agitation compared to control group. In addition, the research also gave idea about the variability in research finding due to difference in the acceptance of treatment by participants, agitation due to unfamiliar assistants (Moyle et al. (2014). Hence, all this is regarded as the confounding factors in the study that has affected the efficacy of the foot massage intervention. The validity of the research finding is questionable because it is not consistent with other studies. For instance, the pilot study by Moyle et al. (2013) has revealed that foot massage significantly reduced levels of agitation in cognitively impaired patients. Hence, the transferability of Moyle et al. (2014) is low due to inconsistency with other research results and presence of confounding factors. Moyle et al. (2014) was also in favor of foot massage to address stress in dementia patient as the findings shows that close presence of another person promoted relaxation in patient.
The estimate of the treatment effect is also understood by the method of statistical analysis of the research data and confidence interval between outcomes in two groups. The proportion of variance was illustrated and the result data mainly showed that there was more than 10% of variance in CMAI and OERS item indicating different factors playing complex role in mood and agitation of individuals (Moyle et al. 2014). Hence, with data regarding means, standard deviation and confidence interval at baseline and post-test for treatment and control groups, the treatment effect was determined. Confidence interval is used by many health care journals as it helps to identify whether a treatment has any effect or not (Freemantle et al. 2013). The overall conclusion regarding the study finding is that desired results was not achieved by providing foot massage to dementia patients and this is explained by some limitations in research methods. For example, familiarity was an issue for many participants as they were disturbed by the presence of a stranger in their room. Hence, if the researcher had considered about familiarity issues, then the research outcome would have been different. There is a need to focus on conditions that will enhance the effect of foot massage (Oliver 2017).
The results of the study cannot be applied in local context because inconsistent result has been found for effect of foot massage on dementia patient. Certain confounding factors affected the outcome and so it is necessary to do further research in this area by modifying the condition under which the treatment was provided. However, moderate benefits were found and it may be applied as there is no selection bias and similar participant group like real setting was selected for the study. The inclusion criteria of taking 65 years above patient living in long-term care with all having recent history of agitation eliminated selection bias. Research has shown that agitation and aggressive behavior is frequently seen in dementia patients living in nursing homes (Husebo, Ballard and Aarsland 2011).
As the research mainly aimed to investigate about the effect of foot massage on agitation and mood in dementia patients, the important clinical outcomes were considered by the researcher. The main outcome variable for the study included agitation and mood and appropriate evidence based tool was used evaluate agitation and mood of participants. For example CMAI tool was used to assess agitation and this is a evidence that has been used in many research related to agitated behavior. Cooke et al. (2010) used CMAI tool to analyze the effect of music programme on agitation and anxiety in dementia patient.
Although the research did not achieved desired results, however the research has benefits because it is the first trial that considered foot massage to address agitation in dementia patient and it has highlighted the potential of foot massage only if the conditions in which the intervention is provided is modified in the future. Hence, the benefits of the research are worth the harm and the cost involved in doing the research. Aggressive behavior is a challenging issue for dementia patient because as it has impact on social life of people. Therefore, research by Kunik et al. (2010) is important as it focused on intervention to reduce aggression in dementia patient.
Reference
Apiliogullari, S. and Onal, O., 2015. Randomization in a crossover design is not to be a minor issue. Anesthesia & Analgesia, 121(4), p.1112.
Cooke, M.L., Moyle, W., Shum, D.H., Harrison, S.D. and Murfield, J.E., 2010. A randomized controlled trial exploring the effect of music on agitated behaviours and anxiety in older people with dementia. Aging and mental health, 14(8), pp.905-916.
Doig, G.S. and Simpson, F., 2014. Understanding clinical trials: emerging methodological issues. Intensive care medicine, 40(11), pp.1755-1757.
Freemantle, N., Marston, L., Walters, K., Wood, J., Reynolds, M.R. and Petersen, I., 2013. Making inferences on treatment effects from real world data: propensity scores, confounding by indication, and other perils for the unwary in observational research. Bmj, 347, p.f6409.
Hayes, R.J. and Moulton, L.H., 2017. Cluster randomised trials. CRC press.
Husebo, B.S., Ballard, C. and Aarsland, D., 2011. Pain treatment of agitation in patients with dementia: a systematic review. International journal of geriatric psychiatry, 26(10), pp.1012-1018.
Karanicolas, P.J., Farrokhyar, F. and Bhandari, M., 2010. Blinding: Who, what, when, why, how?. Canadian journal of surgery, 53(5), p.345.
Kunik, M.E., Snow, A.L., Davila, J.A., McNeese, T., Steele, A.B., Balasubramanyam, V., Doody, R., Schulz, P.E., Kalavar, J.S., Walder, A. and Morgan, R.O., 2010. Consequences of aggressive behavior in patients with dementia. The Journal of neuropsychiatry and clinical neurosciences, 22(1), pp.40-47.
Latimer, N.R., Abrams, K.R., Lambert, P.C., Crowther, M.J., Wailoo, A.J., Morden, J.P., Akehurst, R.L. and Campbell, M.J., 2017. Adjusting for treatment switching in randomised controlled trials–A simulation study and a simplified two-stage method. Statistical methods in medical research, 26(2), pp.724-751.
Moyle, W., Cooke, M.L., Beattie, E., Shum, D.H., O’Dwyer, S.T. and Barrett, S., 2014. Foot massage versus quiet presence on agitation and mood in people with dementia: A randomised controlled trial. International journal of nursing studies, 51(6), pp.856-864.
Moyle, W., Cooke, M.L., Beattie, E., Shum, D.H., O’Dwyer, S.T., Barrett, S. and Sung, B., 2014. Foot massage and physiological stress in people with dementia: a randomized controlled trial. The Journal of Alternative and Complementary Medicine, 20(4), pp.305-311.
Moyle, W., Murfield, J.E., O’Dwyer, S. and Van Wyk, S., 2013. The effect of massage on agitated behaviours in older people with dementia: a literature review. Journal of clinical nursing, 22(5-6), pp.601-610.
Oliver, M., 2017. Effectiveness of Foot Massage on Improving the Balance among Elderly in a Selected Destitute Home, Mangalore. Indian Journal of, 31(4), pp.444-455.
Piantadosi, S., 2017. Clinical trials: a methodologic perspective. John Wiley & Sons.
Schulz, K.F., Altman, D.G., Moher, D. and Consort Group, 2011. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. International journal of surgery, 9(8), pp.672-677.
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