NCT02222181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 months until next milestone

Results Posted

Study results publicly available

May 6, 2016

Completed
Last Updated

May 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

August 4, 2014

Results QC Date

April 3, 2016

Last Update Submit

April 3, 2016

Conditions

Alzheimer's Disease

Keywords

elderly, medication adherence,pharmaceutical care

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Systolic Blood Pressure

    weekly

  • Total Cholesterol

    Total Cholesterol

  • Triglycerides

    three months

  • Glycemia

    two months

  • Diastolic Blood Pressure

    weekly

Study Arms (1)

Pharmacotherapy follow-up

EXPERIMENTAL

patients with Alzheimer's disease

Other: Pharmacotherapy Management

Interventions

Pharmacotherapy ManagementOTHER

* 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.

Pharmacotherapy follow-up

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Fold over pharmacotherapy follow-up;
  • Being institutionalized;
  • Patients unable to respond to collection instruments MMSE and CDR data;
  • Patient without phone contact.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Referência do Idoso de Araraquara - CRIA

Araraquara, São Paulo, 14800240, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 3349924BACKGROUND

  • 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.

    PMID: 19021302BACKGROUND

  • 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.

    PMID: 12975222BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseMedication Adherence

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Fernanda Mariana de Oliveira
Organization
Unesp
femoliveira12@gmail.com
+551636640217

Study Officials

  • Fernanda M Oliveira, student

    Universidade Estadual Paulista Júlio de Mesquita Filho

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree student

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 21, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

May 6, 2016

Results First Posted

May 6, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)