title: PHARMAID study protocol: Randomized controlled trial to assess the impact of integrated pharmaceutical care at a psychosocial intervention on caregiver's burden in Alzheimer's disease or related diseases.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  [ClinicalTrials.gov: NCT02802371] Registered in June 2016.
authors.affiliation: University Lyon, EA-7425 HESPER, Health Services and Performance Research, Lyon F-69003, France; Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France; Pharmaceutical Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France. Electronic address: teddy.novais@chu-lyon.fr.
authors.forename: T
authors.initials: T
authors.lastname: Novais
authors.affiliation: Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France. Electronic address: claire.moutet@chu-lyon.fr.
authors.forename: C
authors.initials: C
authors.lastname: Moutet
authors.affiliation: Clinical and Research Memory Centre of Lyon (CMRR), Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France. Electronic address: floriane.delphin-combe@chu-lyon.fr.
authors.forename: F
authors.initials: F
authors.lastname: Delphin-Combe
authors.affiliation: Clinical and Research Memory Centre of Lyon (CMRR), Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France. Electronic address: virginie.dauphinot@chu-lyon.fr.
authors.forename: V
authors.initials: V
authors.lastname: Dauphinot
authors.affiliation: University Lyon, EA-7425 HESPER, Health Services and Performance Research, Lyon F-69003, France; University Lyon 1, Lyon F-69000, France; Department of Medical Information Evaluation and Research, University Hospital of Lyon, Lyon F-69000, France. Electronic address: cyrille.colin@chu-lyon.fr.
authors.forename: C
authors.initials: C
authors.lastname: Colin
authors.affiliation: Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France; Clinical and Research Memory Centre of Lyon (CMRR), Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France; University Lyon 1, Lyon F-69000, France; INSERM U1028, CNRS UMR5292, Lyon Neuroscience Research Center, Brain Dynamics and Cognition Team, Lyon F-69000, France. Electronic address: pierre.krolak-salmon@chu-lyon.fr.
authors.forename: P
authors.initials: P
authors.lastname: Krolak-Salmon
authors.affiliation: Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France; Pharmaceutical Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne F-69100, France; University Lyon 1, Lyon F-69000, France; INSERM U1028, CNRS UMR5292, Lyon Neuroscience Research Center, Brain Dynamics and Cognition Team, Lyon F-69000, France. Electronic address: christelle.mouchoux@chu-lyon.fr.
authors.forename: C
authors.initials: C
authors.lastname: Mouchoux
mesh_terms: D000223:Adaptation, Psychological; D000544:Alzheimer Disease / Q000451:nursing / Q000628:therapy*; D001294:Attitude to Health; D017028:Caregivers; D003299:Cooperative Behavior; D003695:Delivery of Health Care / Q000379:methods*; D003704:Dementia / Q000451:nursing; D005602:France; D006801:Humans; D010348:Patient Care Team; D010593:Pharmaceutical Services; D012944:Social Support
keywords: Alzheimer's Disease and Related Diseases; Burden; Caregivers; Pharmaceutical care; Psychosocial intervention; Study protocol