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Intervention to Improve the Adherence in Community Pharmacies

A

Andalusian School of Public Health

Status

Unknown

Conditions

Diabetes Mellitus
Arterial Hypertension
Chronic Obstructive Pulmonary Disease (COPD

Treatments

Other: Placebo
Other: ANM

Study type

Interventional

Funder types

Other

Identifiers

NCT04195191
2018713122010

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
The usual practice by community pharmacies
Treatment:
Other: Placebo
ANM
Experimental group
Description:
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.
Treatment:
Other: ANM

Trial contacts and locations

1

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Central trial contact

Antonio Olry de Labry Lima, PhD; Julia gomez

Data sourced from clinicaltrials.gov

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