Intervention to Improve the Adherence in Community Pharmacies
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD, Arterial Hypertension, Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ANM
Placebo
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease (COPD
Eligibility 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
Sites / Locations
- Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
ANM
Arm Description
The usual practice by community pharmacies
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT04195191
First Posted
October 17, 2018
Last Updated
February 3, 2020
Sponsor
Andalusian School of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT04195191
Brief Title
Intervention to Improve the Adherence in Community Pharmacies
Official Title
Effectiveness of an Intervention to Improve the Adherence to Treatment of New Medicines From the Community Pharmacy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
March 2, 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andalusian School of Public Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD, Arterial Hypertension, Diabetes Mellitus
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster randomized controlled trial.
Masking
Outcomes Assessor
Masking Description
The statistical analysis will be performed by a person who would be blinded to which arm were assigned the subjects.
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The usual practice by community pharmacies
Arm Title
ANM
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
ANM
Intervention Description
communication intervention
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
regular assistance in community pharmacies
Primary Outcome Measure Information:
Title
Adherence to treatment
Description
adherence to treatment may be defined as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment.
Time Frame
Ten weeks
Title
Adherence to treatment
Description
adherence to treatment may be defined as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Satisfaction with the service
Description
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).
Time Frame
Ten weeks and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Olry de Labry Lima, PhD
Phone
958027400
Email
antonio.olrylabry.easp@juntadeandalucia.es
First Name & Middle Initial & Last Name or Official Title & Degree
Julia gomez
Phone
+34958027400
Email
julia.gomez.easp@juntadeandalucia.es
Facility Information:
Facility Name
Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).
City
Granada
ZIP/Postal Code
18080
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Olry de Labry Lima, PhD
Phone
958027400
Email
clara.bermudez.easp@juntadeandalucia.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intervention to Improve the Adherence in Community Pharmacies
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