Although this study did not show statistically significant differences owing to the small sample size, the effect size suggests that active interventions by the community pharmacist may reduce the burden of care for caregivers of people with dementia. To discuss factors contributing to the reduction of care burden, we assessed the relevant information from three caregivers (Case 1–3) from the intervention group whose J-ZBI scores improved during the study (Table 4).
Table 4
Summary of three cases in which the caregiving burden reduced
| Case 1 (ID 429) | Case 2 (ID 4540) | Case 3 (ID 73570) |
Primary caregiver | Son | Grandchild | Spouse |
Change in J-ZBI scores | 51 to 50 | 15 to 10 | 31 to 29 |
Items that improved the J-ZBI score* | ・Afraid of what the future holds for your relative | ・Feel that because of the time you spend with your relative that you don't have enough time for yourself | ・Feel that you will be unable to take care of your relative much longer |
| ・Feel stressed between caring for your relative and trying to meet other responsibilities for your family or work | ・Feel you have lost control of your life since your relative's illness |
| ・Afraid of what the future holds for your relative | |
| ・Feel strained when you are around your relative | |
| ・Feel you have lost control of your life since your relative's illness | |
Changes in comprehension scores | 5 to 5 | 3 to 5 | 4 to 5 |
Items that improved in comprehension score* | | ・Understand that there are several types of dementia | ・Understand that there are several types of dementia |
| ・Understand that dementia has peripheral symptoms | |
Problems identified by the pharmacist from the Grasp problem sheet* | ・Take medication at one’s own discretion or not at all | ・Not coping with continued medications | ・Dissatisfied with the current dosing regimen for the rest of their life |
・Discontinue the medication at your own discretion when your condition changes | | ・Lack of care for any changes in the patient’s condition while taking the medicines |
・Not being able to ask questions about medications to healthcare providers without hesitation | | ・Not finding and using the information needed for the patient's medication |
・Not finding and using the information needed for the patient's medication | | Not asking when you don't know about the medication the patient is using |
・Not coping with continued medications | | |
・Not knowing about the medication used by patient and why they are needed. | | |
・Not asking when you don't know about the medication the patient is using | | |
Reply to the form for request of information | Reply from family physician and care manager | Reply from family physician and care manager | Reply from family physician and care manager |
Actions by the family physician or care manager | ・The family physician instructed the pharmacist to visit the patient residence. | ・Care manager asked pharmacists to participate in care conferences. | ཥFamily physician contacted separately |
| | ・Care manager directly contacted. There was an increase in direct contact from care managers to pharmacists (3 times during the study period). | |
Details of the prescription change* | Addition of antitussives | ཥDonepezil dose increased from 3 mg to 5 mg. | ・Linaclotide and mirabegron tablets were discontinued. |
| | ・Changed from internal vicosulfate solution to tablet |
Note. *The items cite the expressions used in the questionnaires; J-ZBI: the Japanese version of Zarit Caregiver Burden Interview. |
In Case 1, the pharmacist identified problems related to the ‘awareness of medication’, ‘collaboration with healthcare providers regarding medication’, and ‘motivation to access and utilize information regarding medication’, including discontinuing medication at own direction, not being able to ask questions about medications to healthcare providers without hesitation, and not knowing about the medication used by the patient and why it is required. This information was shared with the family physician and care manager via ‘The form for request of information’, and the pharmacist was subsequently instructed to visit the patient's residence. As a result, it became possible for the pharmacist to provide the necessary information. For instance, they were able to discuss the need and policy for the patient’s specific pharmacotherapy as well as the features of the additional medication; in response, the pharmacist was provided the opportunity to respond to the caregiver’s questions. These interactions may have served to reduce caregiver anxiety as it would be made clear that the necessary support would be available when required, while also providing the pharmacist with a better understanding of patient and caregiver living circumstances, allowing them to tailor the patient’s care accordingly.
In Case 2, the pharmacist identified problems related to ‘motivation to access and utilize information regarding medication’, particularly related to continuation of medication. Subsequently, through information sharing via ‘The form for request of information’, the frequency of contact between the care manager and pharmacist increased, leading to pharmacist participation in the care conference of the patient in question. Care conferences are organized by care managers and include the gathering of healthcare providers and caregivers to identify specific issues and requests related to the patient’s medical care, while assessing the support measures. During the care conference, the pharmacist involved in the patient’s care is afforded the opportunity to respond directly to the caregiver’s questions and concerns, thus, improving the caregiver’s understanding of dementia. The conference also allows caregivers to experience the benefits of a multi-profession support system in the care of the patient, as well as the support system’s capacity to potentially reduce stress and anxiety associated with care. Additionally, in this specific case, treatment with donepezil was effectively continued after a prescription change. This discussion is also supported by previous reports claiming that the addition of pharmacists to care teams for people with dementia leads to a reduction in the care burden for caregivers [34].
In Case 3, issues related to ‘awareness of medication’ and ‘motivation to access and utilize information regarding medication’ were identified, including dissatisfaction with the current dose for the rest of the patient’s life, lack of regard for any changes in the patient’s condition while taking the medicine, not finding and using the information needed for medication, and not asking questions when not knowing what the patient is using. Subsequently, information obtained through the ‘The form for request of information’ increased the frequency of contact between the family physician and the pharmacist and revealed that the patient was reluctant to use the patch medication, while the caregiver believed that there were no side effects to it. No changes were made to this prescription during the survey period; however, two other medications were discontinued, and the route for administering constipation medication was changed for ease of management. Enhanced collaboration between the physician and pharmacist may have improved the caregivers' comprehension of dementia and reduced the caregivers’ sense of constraint due to the care provided. These findings were consistent with previous reports that have indicated that effective physician-pharmacist communication contributes to a better understanding of patient needs [35], while information sharing among families, physicians, care managers, and other professionals involved in care contributes to a reduction in the care burden [36].
In the three case studies discussed, we believe that the active information gathering from other professionals conducted by the pharmacists in the intervention group enabled the identification and individualization of problems contributing to the burden of care and improved the caregivers' comprehension of medication. Both factors contributed to the reduction in the caregiving burden. This conclusion is supported by the caregivers' improved comprehension of the dementia medication, allowing for better medication control and improved medication adherence [37], and by the reported increase in the caregivers’ self-efficacy and reduction in the burden of caregiving [38–40]. Meanwhile, it has also been reported that psychological interventions for caregivers by healthcare professionals contribute to reduced care burden [41, 42]. Therefore, in the future, it is important for pharmacists to actively conduct information gathering for people with dementia, cooperate with other professionals, share information, and conduct assessments. It will also be important for pharmacists to gain familiarity with programs to support self-care for caregivers, such as cognitive behavioural therapy, and to seek and practice communication and engagement with caregivers.
However, the small sample size and short follow-up period represent limitations of this study. Additionally, interviews conducted with pharmacists after study completion revealed that while the presented protocol was believed to be feasible, the explanatory document provided to the pharmacists requires improvement. Specifically, a more thorough explanation regarding the study design and commitments is required for the pharmacies to provide consent for participation. It was also noted that the intervention process requires simplification. Accordingly, the proposed changes include simplifying the methods by which data is collected, using a shorter version of the J-ZBI (J-ZBI 8) [43], and prolonging the follow-up period (e.g., matching the care manager to the 6-month interval between periodic reviews of the care plan).
Generalizability (applicability) of pilot trial methods and findings to future definitive trial and other studies
The feasibility of this trial was verified. However, large-scale studies are required for further standardization and simplification of the protocol to generalize these results. In addition, accurate outcome measures need to be developed to evaluate the effectiveness and wider application of these interventions. Thus, although this trial focused on dementia, we believe that the protocol can be restructured to be applied to other diseases.