LAUSR

INTRODUCTION Alzheimer's Disease and Related Diseases (ADRD) are associated with a caregiver burden that increases with the progression of the disease. Psychosocial interventions reported a moderate improvement on caregivers' burden. Patients with ADRD and their older caregivers are also exposed to a higher risk of developing drug-related problems. The main objective of the PHARMAID study is to measure the impact of personalized pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on the burden of caregivers. METHODS The PHARMAID study is a 18-month randomized controlled trial that started in September 2016. This paper describes the study protocol. PHARMAID plans to enroll 240 dyads, i.e. ADRD patients and caregivers, whose inclusion criteria are: outpatient with mild or major neurocognitive disorders due to ADRD, living at home, receiving support from a family caregiver. Three parallel groups will compare a control group with two experimental groups: psychosocial intervention and integrated pharmaceutical care at a psychosocial intervention. The main outcome is the caregiver's burden assessed by the Zarit Burden Index at 6, 12 and 18months. DISCUSSION This is the first trial designed to assess the specific impact of the integration of pharmaceutical care in a multidisciplinary psychosocial program on the caregiver's burden. The results will inform policymakers on strategies to implement in the near future. TRIAL REGISTRATION NUMBER [ClinicalTrials.gov: NCT02802371] Registered in June 2016.