Impact of interventions by a community pharmacist on care burden for people with dementia: development and randomized feasibility trial of an intervention protocol

BACKGROUND: Traditionally, the role of pharmacists has been to manage and monitor pharmacotherapy for patients with dementia. However, additional intervention by community pharmacists to collect and share patient information with other professionals may help reduce the care burden among caregivers. The aims of this study were to examine (1) the feasibility of a designed community pharmacist working procedure in dementia care and (2) the expected impact of pharmacist intervention on care burden. METHODS: This was a randomized, open-label, parallel-group feasibility study, involving eight Nara City pharmaceutical association member pharmacies that provided consent to participate. These pharmacies were assigned to an intervention group or a control group at a 1:1 ratio. The subjects were patients with dementia and their primary caregivers that visited the participating pharmacies and provided consent to participate. Pharmacists in the intervention group actively collected information from the patients’ family physicians and care managers and intervened to address medication-related problems, while those in the control group only performed their normal duties. The primary endpoint was a change in the caregiver’s score on the Japanese version of Zarit Caregiver Burden interview (J-ZBI) from the baseline to after 5 months of follow-up. The changes in mean J-ZBI scores from the beginning to the end of the study period of the two groups were compared. RESULTS: Obtaining consent from caregivers was certainly difficult, but possible. Pharmacists managed to fill out the survey form while practising pharmaceutical care. Totally, nine patients and nine caregivers in the intervention group and nine patients and eight caregivers in the control group completed the study. The changes in J-ZBI scores could be calculated for seven cases in the intervention group and five cases in the control group. The J-ZBI scores were found to decrease by 1.0 in the intervention group and increase by 3.0 in the control group. CONCLUSIONS: The protocol presented was considered feasible, but, the intervention process needs to be simplified in order to conduct a large study. Also, improvements are needed in the various survey forms and in the explanatory documents for caregivers. Although the sample size was small, the effect sizes suggested that community pharmacist interventions for patient with dementia may reduce the care burden for caregivers. TRIAL REGISTRATION: UMIN000039949 (registration date: 1 April 2020, retrospectively registered) SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01071-7.