Effectiveness of an Intervention to Improve the Adherence to Treatment of New Medicines From the Community Pharmacy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Adherence to treatment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
The statistical analysis will be performed by a person who would be blinded to which arm were assigned the subjects.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo
The usual practice by community pharmacies
Intervention: Placebo (Other)
ANM
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.
Intervention: ANM (Other)
Outcomes
Primary Outcomes
Adherence to treatment
Time Frame: 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.
Adherence to treatment
Time Frame: Ten weeks
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 Outcomes
- Satisfaction with the service(Ten weeks and six months)