Intervention to Improve the Adherence in Community Pharmacies

Sponsor

Andalusian School of Public Health (Other)

Overall Status

Unknown status

CT.gov ID

NCT04195191

Collaborator

(none)

500

Enrollment

Location

Arms

17.4

Anticipated Duration (Months)

28.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD Arterial Hypertension Diabetes Mellitus	Other: ANM Other: Placebo	N/A

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

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

cluster randomized controlled trial.cluster randomized controlled trial.

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.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 18, 2019

Anticipated Primary Completion Date :

Mar 2, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo The usual practice by community pharmacies	Other: Placebo regular assistance in community pharmacies
Experimental: 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.	Other: ANM communication intervention

Arm

Intervention/Treatment

Placebo Comparator: Placebo

The usual practice by community pharmacies

Other: Placebo

regular assistance in community pharmacies

Experimental: 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.

Other: ANM

communication intervention

Outcome Measures

Primary Outcome Measures

Adherence to treatment [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.
Adherence to treatment [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.

Secondary Outcome Measures

Satisfaction with the service [Ten weeks and six months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andalusian School of Public Health & CIBER en Epidemiología y Salud Pública (CIBERESP).	Granada		Spain	18080

Sponsors and Collaborators

Andalusian School of Public Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andalusian School of Public Health

ClinicalTrials.gov Identifier:

NCT04195191

Other Study ID Numbers:

2018713122010

First Posted:

Dec 11, 2019

Last Update Posted:

Feb 5, 2020

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Hypertension

Study Results

No Results Posted as of Feb 5, 2020