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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacotherapy follow-up | Experimental | patients with Alzheimer's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacotherapy Management | Other |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic pressure <140 mmHg | weekly |
| Total Cholesterol | Total Cholesterol <200 mg/dL | Total Cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernanda M Oliveira, student | Universidade Estadual Paulista Júlio de Mesquita Filho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Referência do Idoso de Araraquara - CRIA | Araraquara | São Paulo | 14800240 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3349924 | Background | 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. | |
| 19021302 | Background | 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. |
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Patients were excluded when in advanced or terminal stage of the disease, lived in nursing homes and when it was not possible to contact the patient.
Experimental, longitudinal and non-randomized study, carried out at Centro de Referência do Idoso de Araraquara (CRIA), from 2014 april to 2015 april, with patients in treatment for Alzheimer's disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacotherapy Follow-up | All the patients received pharmacotherapy workup at baseline and after the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | patients in treatment for Alzheimer's disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mini-mental State Examination (MMEE) | MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage) | Posted | Mean | Standard Deviation | score | six months |
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Do not apply.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Do not apply. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernanda Mariana de Oliveira | Unesp | +551636640217 | femoliveira12@gmail.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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 |
| 12975222 | Background | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | Clinical Dementia Rating (CDR) | CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage) | Posted | Mean | Standard Deviation | score | six months |
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| Secondary | Systolic Blood Pressure | Systolic pressure <140 mmHg | Posted | Mean | Standard Deviation | mmHg | weekly |
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| Secondary | Total Cholesterol | Total Cholesterol <200 mg/dL | Posted | Mean | Standard Deviation | mg/dL | Total Cholesterol |
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| Secondary | Triglycerides | Normal level: 150mg/dL | Posted | Mean | Standard Deviation | mg/dL | three months |
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| Secondary | Glycemia | Normal levels: 70-99mg/dL; diabetic: >121mg/dL. | Posted | Mean | Standard Deviation | mg/dL | two months |
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| Secondary | Diastolic Blood Pressure | Diastolic pressure <90 mmHg | Posted | Mean | Standard Deviation | mmHg | weekly |
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| 0 |
| 55 |
| 0 |
| 55 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |