An interventional study of Pharmacotherapy Management in Alzheimer's Disease, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Completed at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-05-06.
Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable and Interventional
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 55 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
Mini-mental State Examination (MMEE)
MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)
Time frame: six months
Clinical Dementia Rating (CDR)
CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)
Time frame: six months
Systolic Blood Pressure
Systolic pressure \<140 mmHg
Time frame: weekly
Total Cholesterol
Total Cholesterol \<200 mg/dL
Time frame: Total Cholesterol
Triglycerides
Normal level: 150mg/dL
Time frame: three months
Glycemia
Normal levels: 70-99mg/dL; diabetic: \>121mg/dL.
Time frame: two months
Diastolic Blood Pressure
Diastolic pressure \<90 mmHg
Time frame: weekly
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.
| Milestone | Pharmacotherapy Follow-up |
|---|---|
| Started | 163 |
| Completed | 55 |
| Not completed | 108 |
MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)
| score | Pharmacotherapy Follow-up |
|---|---|
| Before | 12 ± 7.3 |
| After | 12 ± 7.8 |
CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)
| score | Pharmacotherapy Follow-up |
|---|---|
| Before | 1.6 ± 0.08 |
| After | 1.7 ± 0.08 |
Systolic pressure \<140 mmHg
| mmHg | Pharmacotherapy Follow-up |
|---|---|
| Before | 136.6 ± 22.3 |
| After | 126.7 ± 18.5 |
Total Cholesterol \<200 mg/dL
| mg/dL | Pharmacotherapy Follow-up |
|---|---|
| Before | 202.2 ± 41.6 |
| After | 187.6 ± 39.5 |
Normal level: 150mg/dL
| mg/dL | Pharmacotherapy Follow-up |
|---|---|
| Before | 154.1 ± 63.2 |
| After | 137.8 ± 48.7 |
Normal levels: 70-99mg/dL; diabetic: \>121mg/dL.
| mg/dL | Pharmacotherapy Follow-up |
|---|---|
| Before | 121.9 ± 57.3 |
| After | 93.9 ± 15.3 |
Diastolic pressure \<90 mmHg
| mmHg | Pharmacotherapy Follow-up |
|---|---|
| Before | 75.49 ± 12 |
| After | 73.03 ± 9.8 |
Collected over Do not apply.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 0/55 (0%) | 0/55 (0%) |
| Age, Categorical(Participants) | Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 46 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 42 |
| Male | 13 |
Plan to share: No
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Universidade Estadual Paulista Júlio de Mesquita Filho