Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma

NCT ID: NCT01644357

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2014-07-31

Brief Summary

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Only a few well-designed studies have investigated the effect of pharmaceutical care on asthma patients and to date there are no published studies investigating this effect specifically on severe and refractory asthma.

The objective of this study is evaluate the effect of pharmaceutical care on asthma control and quality of life (QoL) of patients with severe or refractory asthma compared with pharmacist dispensation only.

Detailed Description

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Conditions

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Asthma Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Dispensing only

Non clinical pharmacists will dispense drugs to patients and usual care will be offered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pharmaceutical care

Patients on experimental group will receive counseling and education on the asthma condition, medication and lifestyle issues. In all visits, the inhaler technique will be reviewed, adherence to treatment and drug related problems were checked. If necessary the patient will be referred to the respiratory specialist to change the medication or to prescribe dose adjustment. Pharmacists document their initial and monthly follow up encounters using a specified form.

Group Type EXPERIMENTAL

Pharmaceutical care

Intervention Type OTHER

Pharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified.

Interventions

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Pharmaceutical care

Pharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with severe/refractory asthma presenting other respiratory disease,
* ≥ 18 years of age,
* using high dose of inhaled corticosteroids (≥ 800mcg of budesonide or equivalent)
* FEV1\<60%,
* regular visitor of the pharmacy and the physicians.

Exclusion Criteria

* participation in other intervention study during this study,
* living in other cities,
* could not participate in all visits of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal University of Bahia

OTHER

Sponsor Role lead

Responsible Party

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Pablo de Moura Santos

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo M Santos, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Álvaro A Cruz, Professor

Role: STUDY_DIRECTOR

Federal University of Bahia

Lúcia B Noblat, Professor

Role: STUDY_CHAIR

Federal University of Bahia

Locations

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Program for Asthma Control (ProAR) of the Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ATENFAR-PROAR

Identifier Type: -

Identifier Source: org_study_id

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