Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Other: Pharmacotherapy Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacotherapy follow-up<br>patients with Alzheimer's disease | Other: Pharmacotherapy Management<br>* assessment of patient characteristics as alcoholic, smoker, food, drugs Pharmacotherapy follow-up to evaluated medication adherence Assessment of the individual clinical parameters each patient at baseline and after the educational or pharmacy intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-mental State Examination (MMEE) | MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage) | six months | 
| Clinical Dementia Rating (CDR) | CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage) | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | Systolic pressure <140 mmHg | weekly | 
| Total Cholesterol | Total Cholesterol <200 mg/dL | Total Cholesterol | 
| Triglycerides | Normal level: 150mg/dL | three months | 
| Glycemia | Normal levels: 70-99mg/dL; diabetic: >121mg/dL. | two months | 
| Diastolic Blood Pressure | Diastolic pressure <90 mmHg | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, medication adherence,pharmaceutical care