Intervention to Improve the Adherence in Community Pharmacies

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195191
• Other study ID #: 2018713122010
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: July 2020

Study information

• Verified date: December 2019
• Source: Andalusian School of Public Health
• Contact: Antonio Olry de Labry Lima, PhD
• Phone: 958027400
• Email: antonio.olrylabry.easp[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Chronic Obstructive Pulmonary Disease (COPD
• Diabetes Mellitus
• Hypertension
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• ANM
communication intervention
• Placebo
regular assistance in community pharmacies

Locations

Country	Name	City	State
Spain	Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian School of Public Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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