Intervention to Improve the Adherence in Community Pharmacies

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease (COPD; Arterial Hypertension; Diabetes Mellitus

• Registration Number: NCT04195191
• Lead Sponsor: Andalusian School of Public Health

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.

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 Timeline

• Study First Submitted: 2018-10-17
• Study Start: 2019-01-18
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-03-02
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to treatment	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the service	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).

Trial Locations

Locations (1)

Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).; 🇪🇸 Granada, Spain