Alzheimer's Disease
Conditions
Keywords
elderly, medication adherence,pharmaceutical care
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.
Interventions
OTHERPharmacotherapy 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.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini-mental State Examination (MMEE) | six months | MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage) |
| Clinical Dementia Rating (CDR) | six months | CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides | three months | Normal level: 150mg/dL |
| Systolic Blood Pressure | weekly | Systolic pressure \<140 mmHg |
| Diastolic Blood Pressure | weekly | Diastolic pressure \<90 mmHg |
| Glycemia | two months | Normal levels: 70-99mg/dL; diabetic: \>121mg/dL. |
| Total Cholesterol | Total Cholesterol | Total Cholesterol \<200 mg/dL |
Countries
Brazil
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment patients in treatment for Alzheimer's disease. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 46 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacotherapy Follow-up | Clinical Dementia Rating (CDR) | After | 1.7 score | Standard Deviation 0.08 |
| Pharmacotherapy Follow-up | Clinical Dementia Rating (CDR) | Before | 1.6 score | Standard Deviation 0.08 |
p-value: 0.05t-test, 1 sided
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacotherapy Follow-up | Mini-mental State Examination (MMEE) | Before | 12 score | Standard Deviation 7.3 |
| Pharmacotherapy Follow-up | Mini-mental State Examination (MMEE) | After | 12 score | Standard Deviation 7.8 |
p-value: 0.23t-test, 1 sided
Secondary
Diastolic Blood Pressure
Diastolic pressure \<90 mmHg
Time frame: weekly
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacotherapy Follow-up | Diastolic Blood Pressure | Before | 75.49 mmHg | Standard Deviation 12 |
| Pharmacotherapy Follow-up | Diastolic Blood Pressure | After | 73.03 mmHg | Standard Deviation 9.8 |
p-value: 0.05t-test, 1 sided
Secondary
Glycemia
Normal levels: 70-99mg/dL; diabetic: \>121mg/dL.
Time frame: two months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacotherapy Follow-up | Glycemia | Before | 121.9 mg/dL | Standard Deviation 57.3 |
| Pharmacotherapy Follow-up | Glycemia | After | 93.9 mg/dL | Standard Deviation 15.3 |
p-value: <0.001t-test, 1 sided
Secondary
Systolic Blood Pressure
Systolic pressure \<140 mmHg
Time frame: weekly
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacotherapy Follow-up | Systolic Blood Pressure | Before | 136.6 mmHg | Standard Deviation 22.3 |
| Pharmacotherapy Follow-up | Systolic Blood Pressure | After | 126.7 mmHg | Standard Deviation 18.5 |
p-value: 0.03t-test, 1 sided
Secondary
Total Cholesterol
Total Cholesterol \<200 mg/dL
Time frame: Total Cholesterol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacotherapy Follow-up | Total Cholesterol | Before | 202.2 mg/dL | Standard Deviation 41.6 |
| Pharmacotherapy Follow-up | Total Cholesterol | After | 187.6 mg/dL | Standard Deviation 39.5 |
p-value: <0.001t-test, 1 sided
Secondary
Triglycerides
Normal level: 150mg/dL
Time frame: three months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacotherapy Follow-up | Triglycerides | Before | 154.1 mg/dL | Standard Deviation 63.2 |
| Pharmacotherapy Follow-up | Triglycerides | After | 137.8 mg/dL | Standard Deviation 48.7 |
p-value: 0.025t-test, 1 sided