NCT06729697

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

April 13, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

November 21, 2024

Last Update Submit

April 9, 2025

Conditions

Keywords

Pharmaceutical literacyHealth related quality of lifeSpainCommunity pharmacist

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Through study completion, an average of 1 year.

Secondary Outcomes (8)

  • Sex

    Through study completion, an average of 1 year.

  • Age

    Through study completion, an average of 1 year.

  • Country of birth

    Through study completion, an average of 1 year.

  • Level of education

    Through study completion, an average of 1 year.

  • Situation related to economic activity

    Through study completion, an average of 1 year.

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacy and Pharmaceutical Care Unit.

Barcelona, Barcelona, 08028, Spain

Location

Related Publications (2)

  • 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: 36810042BACKGROUND
  • 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: 36868912BACKGROUND

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Pilar Modamio Charles, PhD

    University of Barcelona

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 21, 2024

First Posted

December 11, 2024

Study Start

November 15, 2024

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

April 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations