Intervention to Improve the Adherence in Community Pharmacies

February 3, 2020 updated by: Andalusian School of Public Health

Effectiveness of an Intervention to Improve the Adherence to Treatment of New Medicines From the Community Pharmacy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18080
        • Recruiting
        • Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: patient who starts treatment of any of the following diseases:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
The usual practice by community pharmacies
Other: Placebo
regular assistance in community pharmacies
Experimental: 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.
Other: ANM
communication intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: Ten weeks
adherence to treatment may be defined as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment.
Ten weeks
Adherence to treatment
Time Frame: Six months
adherence to treatment may be defined as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the service
Time Frame: Ten weeks and six months
The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial. The satisfaction with the service, will be collected thru a likert question (1 not satisfied, 10 very satisfied).
Ten weeks and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Anticipated)

March 2, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 11, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018713122010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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