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Completed

NCT Number: NCT02222181

Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Referência do Idoso de Araraquara - CRIA

Araraquara, São Paulo, 14800240, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacotherapy Management

Other
  • 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.

Primary outcomes

  1. Mini-mental State Examination (MMEE)

    Time frame: six months

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

  2. Clinical Dementia Rating (CDR)

    Time frame: six months

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

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: weekly

    Systolic pressure <140 mmHg

  2. Total Cholesterol

    Time frame: Total Cholesterol

    Total Cholesterol <200 mg/dL

  3. Triglycerides

    Time frame: three months

    Normal level: 150mg/dL

  4. Glycemia

    Time frame: two months

    Normal levels: 70-99mg/dL; diabetic: >121mg/dL.

  5. Diastolic Blood Pressure

    Time frame: weekly

    Diastolic pressure <90 mmHg

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2014
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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