Pharmaceutical Literacy and Quality of Life in Spanish Population.

April 9, 2025 updated by: Pilar Modamio, University of Barcelona

Pharmaceutical Literacy in Spanish Population and Association With Health-Related Quality of Life

The goal of this study is to learn about the knowledge and abilities that patients have regarding their own medication and to see if that's related to their quality of life.

The main questions it aims to answer are:

  • Are patients abilities and knowledge about their medications sufficient to ensure a safe and efective use?
  • Are those knowledge and abilities related to the patient's quality of life? How?

Patients already taking at least one medication will answer questions about their abilities and knowledge towards medication and their quality of life related to their health state.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

A cross-sectional study is carried out, consisting of an interview between the patients and community pharmacists included in the study.

The participants selected are adults usually taking medication that answer questions related to their pharmaceutical literacy (RALPH interview). This type of literacy refers to three domains regarding functional, comunicative and critical abilities about their own medication.

After that, every participant answers a simple survey regarding their health-related quality of life including topics such as mobility, self-care, everyday activities, pain and mental health (EQ-5D-5L survey).

The recruitment and interviewing take place at the same time, and it requires less than 30 minutes per patient. No follow-up is needed afterward.

There are no risks associated with this procedure, and the participation of the patients will always be voluntary and anonymous.

Previously to the patients' enrollment in the study, proper information will be given to the potential participants and an informed consent will be signed.

Study Type

Observational

Enrollment (Estimated)

1246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Clinical Pharmacy and Pharmaceutical Care Unit.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults taking at least one medication in Spain at the moment of the study.

Description

Inclusion Criteria:

  • Adults currently taking at least one medication prescribed by a physician and living in Spain.

Exclusion Criteria:

  • Having physical or cognitive limitations that make it impossible to answer the study questions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recognising and Addressing Limited Pharmaceutical Literacy (RALPH) interview guide score
Time Frame: Through study completion, an average of 1 year.
A quantitative score will be obtained after an interview using the RALPH guide for community pharmacy. Only correct answered questions will add a point to the score. The values obtained stand between 0 and 10, and a higher score means a better outcome.
Through study completion, an average of 1 year.
EQ-5D-5L index score
Time Frame: Through study completion, an average of 1 year.
A health state index score will be calculated from individual health profiles using the Spanish value set (Roudijk B, Ludwig K, Devlin N, Roudijk B, Ludwig K, Devlin N. EQ-5D-5L Value Set Summaries. Value Sets for EQ-5D-5L. 2022;55-212.) where the values stand between -0.166 and 1, and a higher score means a better outcome.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex
Time Frame: Through study completion, an average of 1 year.
Sex according to the categories: male or female.
Through study completion, an average of 1 year.
Age
Time Frame: Through study completion, an average of 1 year.
Age in years.
Through study completion, an average of 1 year.
Country of birth
Time Frame: Through study completion, an average of 1 year.
Name of the country of birth.
Through study completion, an average of 1 year.
Level of education
Time Frame: Through study completion, an average of 1 year.
Education level according to the 4 categories: uneducated, primary education, secondary education and higher education.
Through study completion, an average of 1 year.
Situation related to economic activity
Time Frame: Through study completion, an average of 1 year.
Economic activity according to the 7 categories: working, unemployed, retired, studying, unable to work, mainly engaged in housework and other situations.
Through study completion, an average of 1 year.
Working time
Time Frame: Through study completion, an average of 1 year.
If working, type of working time according to the categories: full time and part time.
Through study completion, an average of 1 year.
Time since the prescription of the medicine
Time Frame: Through study completion, an average of 1 year.
Time in months.
Through study completion, an average of 1 year.
Total number of medicines prescribed per day
Time Frame: Through study completion, an average of 1 year.
Number of medicines prescribed per day according to the categories: less than 5 medicines and more than 5.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria

Investigators

  • Study Director: Pilar Modamio Charles, PhD, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CER052416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Acording to the protocol aproved by the Bioethics Commission of the University of Barcelona, the IPD will not be shared with other researchers since it is not an interventional study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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