Clinical trial NCT06729697: Pharmaceutical Literacy and Quality of Life in Spanish Population.
Official title: Pharmaceutical Literacy in Spanish Population and Association With Health-Related Quality of Life
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Health Related Quality of Life
Literacy
Keywords: Pharmaceutical literacy
Health related quality of life
Spain
Community pharmacist
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria
First posted: 2024-12-11
Enrollment: 1246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults taking at least one medication in Spain at the moment of the study.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recognising and Addressing Limited Pharmaceutical Literacy (RALPH) interview guide score
timeFrame: Through study completion, an average of 1 year.
measure: EQ-5D-5L index score
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Sex
timeFrame: Through study completion, an average of 1 year.
measure: Age
timeFrame: Through study completion, an average of 1 year.
measure: Country of birth
timeFrame: Through study completion, an average of 1 year.
measure: Level of education
timeFrame: Through study completion, an average of 1 year.
measure: Situation related to economic activity
timeFrame: Through study completion, an average of 1 year.
measure: Working time
timeFrame: Through study completion, an average of 1 year.
measure: Time since the prescription of the medicine
timeFrame: Through study completion, an average of 1 year.
measure: Total number of medicines prescribed per day
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinical Pharmacy and Pharmaceutical Care Unit.
Study officials:
affiliation: University of Barcelona
name: Pilar Modamio Charles, PhD
role: STUDY_DIRECTOR
References:
citation: Roudijk B, Ludwig K, Devlin N. EQ-5D-5L Value Set Summaries. 2022 Mar 24. In: Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. Chapter 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK589305/
citation: Andreu-March M, Aguas Compaired M, Marino EL, Modamio P. Cross-cultural adaptation and validation of the Recognizing And Addressing Limited Pharmaceutical Literacy (RALPH) interview guide in community pharmacies. Res Social Adm Pharm. 2023 Jun;19(6):882-888. doi: 10.1016/j.sapharm.2023.02.004. Epub 2023 Feb 16.