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临床试验/NCT02222181
NCT02222181已完成不适用

Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

Universidade Estadual Paulista Júlio de Mesquita Filho1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Clinical Dementia Rating (CDR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

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

研究组 & 干预措施

Pharmacotherapy follow-up

Experimental

patients with Alzheimer's disease

干预措施: Pharmacotherapy Management (Other)

结局指标

主要结局

Clinical Dementia Rating (CDR)

时间窗: six months

CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)

Mini-mental State Examination (MMEE)

时间窗: six months

MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)

次要结局

  • Triglycerides(three months)
  • Systolic Blood Pressure(weekly)
  • Total Cholesterol(Total Cholesterol)
  • Glycemia(two months)
  • Diastolic Blood Pressure(weekly)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernanda Mariana de Oliveira

Master's degree student

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (1)

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