Intervention to Improve the Adherence in Community Pharmacies

NCT04195191 | Unknown DMC

• 1 other identifier: 2018713122010
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD; Arterial Hypertension; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Satisfaction with the service

  Ten weeks and six months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The usual practice by community pharmacies

Other: Placebo

ANM

EXPERIMENTAL

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

Interventions

ANM OTHER

communication intervention

ANM

Placebo OTHER

regular assistance in community pharmacies

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andalusian School of Public Health: lead

Study Sites (1)

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

Granada, 18080, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Antonio Olry de Labry Lima, PhD

CONTACT

958027400; antonio.olrylabry.easp@juntadeandalucia.es

Julia gomez

CONTACT

+34958027400; julia.gomez.easp@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analysis will be performed by a person who would be blinded to which arm were assigned the subjects.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: cluster randomized controlled trial.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: December 11, 2019
• Study Start: January 18, 2019
• Primary Completion: March 2, 2020
• Study Completion: July 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)