Intervention to Improve the Adherence in Community Pharmacies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD, Arterial Hypertension, Diabetes Mellitus

Intervention / Treatment
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* Other: ANM
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster randomized controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The usual practice by community pharmacies | Other: Placebo<br>* regular assistance in community pharmacies<br>|
| Experimental: ANM<br>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<br>* communication intervention<br>|

What is the study measuring?
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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 |