Pharmaceutical Literacy and Quality of Life in Spanish Population.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Health Related Quality of Life, Literacy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmaceutical Literacy in Spanish Population and Association With Health-Related Quality of Life
Overview
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.
Primary outcome measures
- Recognising and Addressing Limited Pharmaceutical Literacy (RALPH) interview guide score [Time frame: Through study completion, an average of 1 year.]
- EQ-5D-5L index score [Time frame: Through study completion, an average of 1 year.]
Secondary outcome measures (8)
- Sex [Time frame: Through study completion, an average of 1 year.]
- Age [Time frame: Through study completion, an average of 1 year.]
- Country of birth [Time frame: Through study completion, an average of 1 year.]
- Level of education [Time frame: Through study completion, an average of 1 year.]
- Situation related to economic activity [Time frame: Through study completion, an average of 1 year.]
- Working time [Time frame: 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.]
- Total number of medicines prescribed per day [Time frame: Through study completion, an average of 1 year.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Spain · 1 center
- Clinical Pharmacy and Pharmaceutical Care Unit. — Barcelona
Publications
- 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/ PMID 36810042
- 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. PMID 36868912
Identifiers
NCT: NCT06729697 · CER052416