Intervention to Improve the Adherence in Community Pharmacies

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: Diabetes Mellitus; Arterial Hypertension; Chronic Obstructive Pulmonary Disease (COPD
• Intervention / Treatment: Other: Placebo; Other: ANM

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

• Study Contact: Name: Antonio Olry de Labry Lima, PhD; Phone Number: 958027400; Email: antonio.olrylabry.easp@juntadeandalucia.es
• Study Contact Backup: Name: Julia gomez; Phone Number: +34958027400; Email: julia.gomez.easp@juntadeandalucia.es

Study Locations

• Spain
  • Granada, Spain, 18080
    • Recruiting
    • Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).
    • Contact: Antonio Olry de Labry Lima, PhD; Phone Number: 958027400; Email: clara.bermudez.easp@juntadeandalucia.es

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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

• Sponsor: Andalusian School of Public Health

Study record dates

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: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• 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