Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

NCT ID: NCT02222181

Last Updated: 2016-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-03-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Pharmacotherapy follow-up

patients with Alzheimer's disease

Group Type: EXPERIMENTAL

Pharmacotherapy Management

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Mariana de Oliveira

Master's degree student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernanda M Oliveira, student

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual Paulista Júlio de Mesquita Filho

Locations

Centro de Referência do Idoso de Araraquara - CRIA

Araraquara, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 3349924 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19021302 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12975222 (View on PubMed)

Other Identifiers

24947914.5.0000.5426

Identifier Type: -

Identifier Source: org_study_id