JMIR Publications

ABSTRACT

Background:

Chronic metabolic diseases, including hypertension, diabetes mellitus, and dyslipidemia, require sustained pharmacotherapy, the clinical effectiveness of which depends substantially on medication adherence. Adherence is a multidimensional construct with both behavioral and cognitive dimensions; within the Necessity-Concerns Framework, patients’ beliefs about the necessity of and concerns about their medicines are established cognitive determinants of adherence behavior. Community pharmacists are increasingly recognized as key contributors to promoting adherence, yet standardized approaches to assessing adherence-related beliefs with validated patient-reported outcome (PRO) instruments remain limited in Japanese community pharmacy practice.

Objective:

The primary objective is to characterize adherence-related beliefs—specifically medication necessity beliefs and concerns—among patients with hypertension, diabetes mellitus, or dyslipidemia who use community pharmacies in Japan. The secondary objective is to examine the associations between these beliefs, trust in physicians, and satisfaction with pharmacist services and subsequent medication intensification.

Methods:

This multicenter, prospective, observational cohort study was conducted across 7 community pharmacies affiliated with the Hachioji Pharmacists’ Association in Tokyo, Japan. Eligible participants were adults aged 18 years or older who were receiving pharmacotherapy for hypertension, diabetes mellitus, or dyslipidemia and initiating a new medication or undergoing dose escalation at enrollment. The primary outcomes were the necessity score, the concerns score, and the necessity-concerns differential (NCD) derived from the Japanese version of the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific), with subscales scored as mean item scores. Secondary outcomes included satisfaction with pharmacist services (Functional Assessment of Chronic Illness Therapy-Satisfaction with Pharmacist [FACIT-SWiP]), trust in physicians (short-form Wake Forest Physician Trust Scale [WFPTS]), and the association of baseline scores with time to medication intensification, defined as dose escalation of an existing medication or addition of a new medication for a target condition. PRO instruments were administered at baseline through an electronic PRO system, and prescription records were reviewed over 12 months to identify intensification events. A target sample size of approximately 500 participants was set on feasibility grounds.

Results:

Enrollment began in August 2025 and was completed in July 2026, with 414 participants enrolled. Each participant is being followed for 12 months after enrollment. This protocol was submitted after enrollment had been completed. Data collection is expected to be completed in July 2027, and the primary results are expected to be submitted for publication in 2028. No outcome data have been analyzed at the time of manuscript submission.

Conclusions:

This study will provide foundational data on adherence-related beliefs, trust in physicians, and satisfaction with pharmacist services across three chronic metabolic conditions in real-world Japanese community pharmacy settings. The findings are expected to inform the development of pharmacist-led interventions and patient-centered strategies to support long-term medication use. Clinical Trial: UMIN Clinical Trials Registry UMIN000058581; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067012