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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The usual practice by community pharmacies |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANM | Other | communication intervention |
| |
| Placebo |
| 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 |
| 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 |
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Inclusion Criteria: patient who starts treatment of any of the following diseases:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Olry de Labry Lima, PhD | Contact | 958027400 | antonio.olrylabry.easp@juntadeandalucia.es | |
| Julia gomez | Contact | +34958027400 | julia.gomez.easp@juntadeandalucia.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andalusian School of Public Health & CIBER en EpidemiologÃa y Salud Pública (CIBERESP). | Recruiting | Granada | 18080 | Spain |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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cluster randomized controlled trial.
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The statistical analysis will be performed by a person who would be blinded to which arm were assigned the subjects.
| Other |
regular assistance in community pharmacies |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |