Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Impact of Pharmacotherapy Management in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02222181
• Other study ID #: 24947914.5.0000.5426
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2014
• Last updated: May 28, 2015
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: August 2014
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: Fernanda M Oliveira, student
• Phone: +5516981417029
• Email: fernanda_moliveira[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

In Brazil, patients with Azheimer'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 . Will be assessed the clinical parameters at the beginning and after the educational intervention period from April 2014 to December 2015.

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 Azheimer'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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
Brazil	Centro de Referência do Idoso de Araraquara - CRIA	Araraquara	São Paulo

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., CRIA - Centro de Referência do Idoso de Araraquara, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Arlt S, Lindner R, Rösler 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. Review. — View Citation

Lanctôt 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mini-mental state examination (MMEE) and CDR	Scores value of MMEE and CDRE will be utilized of classification of degree of ilness. score is related to educational level.; MEEM: score > 25 : excluded of service: normal anging score 24-12: > 4 years of education score 8-17: up to 4 years of education score 8 :illiterate; score -; CDR:	six months	No
Secondary	glycated hemoglobin	Normal level for Elderly: < 8%	three months	No
Secondary	Total cholesterol	Normal level : < 200mm/Hg	three months	No
Secondary	triglycerides	Normal level: 150mg/dL	three months	No
Secondary	Cholesterol - HDL	Normal level: 40mg/dL - 60 mg/dL	three months	No
Secondary	Cholesterol - LDL	Normal levels: <130mg/dL	three months	No
Secondary	Thyroid-Stimulating Hormone (TSH)	Normal levels: 0,4-4,0 mUI/mL	Two months	No
Secondary	Prostate-Specific Antigen (PSA)	Normal levels: <3,0ng/mL	three months	No
Secondary	Glycemia	Normal levels: 70-99mg/dL Pre-diabetic: 100-120; Diabetic: >121mg/dL:	two months	No
Secondary	Serum iron	Normal levels: For man: 75-175 µg/dL For woman: 65-165 µg/dL	Two months	No
Secondary	Liver enzymes	Normal levels: AST/TGO: 10-39 U/L and ALT/TGP: 10 - 45 U/L	two months	No
Secondary	Vitamin B12	Normal levels: 210-980 pg/mL	two months	No
Secondary	Creatinine	Normal levels: 0,6-1,0 mg/dL	Two months	No
Secondary	Urea	Normal Levels: 15-40 mg/dL	Two months	No
Secondary	Electrolytes	Normal levels: sodium: 138-148mEq/L; potassium: 3,8-5,5 mEq/L; magnesium: 1,9-2,5 mg/dL ; calcium: 8,8-11,0 mg/dL; phosphorus: 2,5-4,8 mg/dL (adult)	Two months	No
Secondary	Blood pressure	Normal level: systolic pressure <130 mmHg and diastolic pressure <85 mmHg	weekly	No