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Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02222181
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Fernanda Mariana de Oliveira, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Pharmacotherapy Management Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease
Study Start Date : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pharmacotherapy follow-up
patients with Alzheimer's disease
 Other: Pharmacotherapy Management
  • 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222181


Locations
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Brazil
Centro de Referência do Idoso de Araraquara - CRIA
Araraquara, São Paulo, Brazil, 14800240
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Fernanda M Oliveira, student Universidade Estadual Paulista Júlio de Mesquita Filho
More Information
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Publications:

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Responsible Party: Fernanda Mariana de Oliveira, Master's degree student, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02222181    
Other Study ID Numbers: 24947914.5.0000.5426
First Posted: August 21, 2014    Key Record Dates
Results First Posted: May 6, 2016
Last Update Posted: May 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fernanda Mariana de Oliveira, Universidade Estadual Paulista Júlio de Mesquita Filho:
elderly, medication adherence,pharmaceutical care
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders