Clinical trial NCT02222181: Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease
Official title: Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: elderly, medication adherence,pharmaceutical care
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2014-08-21
Enrollment: 55
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In Brazil, patients with Alzheimer's disease (AD) receiving free drugs of government. Even having access to, little is known about the effectiveness, safety and adherence of drug therapy in this group of patients. The research aims to promote adherence and develop strategies to address Drug-Related Problems (DRP's) in AD patients elderly of reference centre for the Elderly of Araraquara. The clinical parameters will be assessed at the beginning and after the educational intervention period from April 2014 to April 2015.

Detailed description: Dementia is characterized by memory loss associated with cognitive impairment, which directly interferes in learning process, social and professional performance, besides being the main cause of dementia or Alzheimer's disease (AD). In Brazil, patients are medicated for AD through "Programa de Medicamentos Excepcionais" (Exceptional Drug Program) that ensure the patient´s treatment by providing high cost medications. Even having access to, little is known about the effectiveness, safety and adherence of drug therapy in this group of patients. The research aims to promote adherence and develop strategies to address Drug-Related Problems (DRP's) in AD patients. For this end, we intend to conduct a descriptive, almost experimental and longitudinal uncontrolled research, from April 2014 to December 2015, at the CRIA: "Centro de Referência do Idoso de Araraquara" (Reference Centre for the Elderly of Araraquara). Patients included in the research must have a diagnosis of AD and must be using drugs supplied by the "Programa de Medicamentos Excepcionais". For data collection pharmaceutical care will be employed as a technique, carried out through pharmaceutical meetings, including the steps of initial assessment, care plan (pharmaceutical intervention) and results evaluation. The results will be monitored for pharmacotherapy adherence, cognitive assessment and other clinical parameters related to their health problems and resolution of DRP's before and after the proposed follow-up.The expected outcomes include knowledge of the medication experiences of AD patients, how they influence the adherence and other DRP's and how they can contribute by solving these problems, in addition to the impact evaluation of pharmaceutical care in cognitive improving and other clinical parameters monitored and evaluated individually.

Eligibility criteria: Inclusion Criteria:

* Elderly patients who are assisted in CRIA, diagnosed with Alzheimer's in use of rivastigmine or donepezil or galantamine, assisted by the "Program for special drugs".
* Be resident in the city of Araraquara / SP
* Accept part of pharmacotherapeutic follow-up;
* Sign the Statement of Informed Consent Form (ICF).

Exclusion Criteria:

* Fold over pharmacotherapy follow-up;
* Being institutionalized;
* Patients unable to respond to collection instruments MMSE and CDR data;
* Patient without phone contact.

Primary outcomes:
measure: Mini-mental State Examination (MMEE)
timeFrame: six months
measure: Clinical Dementia Rating (CDR)
timeFrame: six months
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: weekly
measure: Total Cholesterol
timeFrame: Total Cholesterol
measure: Triglycerides
timeFrame: three months
measure: Glycemia
timeFrame: two months
measure: Diastolic Blood Pressure
timeFrame: weekly
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Centro de Referência do Idoso de Araraquara - CRIA
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
name: Fernanda M Oliveira, student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strand LM, Cipolle RJ, Morley PC. Documenting the clinical pharmacist's activities: back to basics. Drug Intell Clin Pharm. 1988 Jan;22(1):63-7. doi: 10.1177/106002808802200116.
citation: Arlt S, Lindner R, Rosler A, von Renteln-Kruse W. Adherence to medication in patients with dementia: predictors and strategies for improvement. Drugs Aging. 2008;25(12):1033-47. doi: 10.2165/0002512-200825120-00005.
citation: Lanctot KL, Herrmann N, Yau KK, Khan LR, Liu BA, LouLou MM, Einarson TR. Efficacy and safety of cholinesterase inhibitors in Alzheimer's disease: a meta-analysis. CMAJ. 2003 Sep 16;169(6):557-64.