Health Related Quality of LifeNCT06729697
Pharmaceutical Literacy and Quality of Life in Spanish Population.
An observational study of Health Related Quality of Life and Literacy, run by University of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Related Quality of Life, Literacy
- How many people
- 1,246 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults taking at least one medication in Spain at the moment of the study.
Who may be able to join
- Adults currently taking at least one medication prescribed by a physician and living in Spain.
Who cannot join
- Having physical or cognitive limitations that make it impossible to answer the study questions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Clinical Pharmacy and Pharmaceutical Care Unit.
Barcelona, Barcelona, 08028
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Related Quality of Life, Literacy
- Keywords
- Pharmaceutical literacy, Health related quality of life, Spain, Community pharmacist
- Medical subject headings
- Literacy
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognising and Addressing Limited Pharmaceutical Literacy (RALPH) interview guide score
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.
Measured: Through study completion, an average of 1 year.
EQ-5D-5L index score
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (8)
Sex
Sex according to the categories: male or female.
Measured: Through study completion, an average of 1 year.
Age
Age in years.
Measured: Through study completion, an average of 1 year.
Country of birth
Name of the country of birth.
Measured: Through study completion, an average of 1 year.
Level of education
Education level according to the 4 categories: uneducated, primary education, secondary education and higher education.
Measured: Through study completion, an average of 1 year.
Situation related to economic activity
Economic activity according to the 7 categories: working, unemployed, retired, studying, unable to work, mainly engaged in housework and other situations.
Measured: Through study completion, an average of 1 year.
Working time
If working, type of working time according to the categories: full time and part time.
Measured: Through study completion, an average of 1 year.
Time since the prescription of the medicine
Time in months.
Measured: Through study completion, an average of 1 year.
Total number of medicines prescribed per day
Number of medicines prescribed per day according to the categories: less than 5 medicines and more than 5.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria
- Responsible party
- Principal investigator, Pilar Modamio, University of Barcelona
- Investigators
- Pilar Modamio Charles, PhD, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729697
- Sponsor's protocol ID
- CER052416
- Status last verified
- Mar 2025
- First submitted
- 21 Nov 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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/
PubMed 36810042Andreu-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.
PubMed 36868912
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Literacy in Spanish Population and Association With Health-Related Quality of Life
- ClinicalTrials.gov ID
- NCT06729697
- Acronym / sponsor ID
- CER052416
- Conditions
- Health Related Quality of Life, Literacy
- Keywords
- Pharmaceutical literacy, Health related quality of life, Spain, Community pharmacist
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,246 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Sociedad Espanola de Farmacia Clinica, Familiar y Comunitaria
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults taking at least one medication in Spain at the moment of the study.
Key inclusion criteria (1 listed)
- Adults currently taking at least one medication prescribed by a physician and living in Spain.
Key exclusion criteria (1 listed)
- Having physical or cognitive limitations that make it impossible to answer the study questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 36810042Roudijk 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/
- Background: PubMed 36868912Andreu-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pilar Modamio Charles, PhD study director
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Related Quality of Life and Literacy, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognising and Addressing Limited Pharmaceutical Literacy (RALPH) interview guide score (time frame: Through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06729697, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.