Intervention to Improve the Adherence in Community Pharmacies

NCT ID: NCT04195191

Last Updated: 2020-02-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2020-07-31

Brief Summary

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The ANM is the first initiative that puts advanced pharmaceutical care into practice in Andalusia (Spain). The aim of this is study is to evaluate the effectiveness of the intervention Assistance to New Medicines (ANM) in the improvement of adherence to treatment in community pharmacies.

Detailed Description

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Design: parallel cluster pragmatic randomized controlled trial. The study includes patients users of a community pharmacies, who meet the following inclusion criteria: patient who starts treatment of any of the following pathologies: Chronic Obstructive Pulmonary Disease (COPD), Arterial Hypertension or Diabetes Mellitus in Andalusia (Spain).

In order to avoid possible contamination between patients assigned to the control and intervention group, randomization will be carried out at the pharmacy level; preventing the pharmacist from applying part of the intervention to the control group.

Interventions: patients randomized: (i) current practice; or (ii) ANM intervention thru a pharmacist delivered support for a newly prescribed medicine.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD Arterial Hypertension Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster randomized controlled trial.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The statistical analysis will be performed by a person who would be blinded to which arm were assigned the subjects.

Study Groups

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Placebo

The usual practice by community pharmacies

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

regular assistance in community pharmacies

ANM

This is an intervention based on pharmaceutical-patient communication through an open and fluid conversation, aimed at evaluating the patient's relationship with their new prescription, detecting possible problems, concerns and false beliefs or visual expectations.

Group Type EXPERIMENTAL

ANM

Intervention Type OTHER

communication intervention

Interventions

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ANM

communication intervention

Intervention Type OTHER

Placebo

regular assistance in community pharmacies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic Obstructive Pulmonary Disease (COPD).
* Arterial Hypertension
* Diabetes Mellitus.
* Anticoagulants

Exclusion Criteria

* those users who do not know how to read and write in Spanish,
* Suffer from a physical or mental disorder that makes it impossible to perform the
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Andalusian School of Public Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Antonio Olry de Labry Lima, PhD

Role: CONTACT

958027400

Julia gomez

Role: CONTACT

+34958027400

Facility Contacts

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Antonio Olry de Labry Lima, PhD

Role: primary

958027400

Other Identifiers

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2018713122010

Identifier Type: -

Identifier Source: org_study_id

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