Survey on the Evaluation of Medication Information Leaflets for Organ Transplant Patients

NCT06652919 | Recruiting

• 1 other identifier: Clinical Pharmacy Uni MS_2024
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to collect feedback from organ transplant patients or their caregivers/relatives on the medication information leaflets we've developed, using a questionnaire, and to adjust the content to better meet the specific needs of this unique patient group.

Conditions

Organ Transplantation

Keywords

Organ transplantation; Consumer Information Rating Form; Pharmaceutical Care; Community Pharmacy; Patient Information Leaflets

Outcome Measures

Primary Outcomes (2)

• Consumer Information Rating Form (CIRF): Mean "comprehensibility" score, mean "future use" score, mean "utility" score and mean "design quality" score.

  In this research, the measurement instrument called the Consumer Information Rating Form (CIRF) is used, though the content has been slightly adapted to fit our study. It was developed as a direct method for quantifying consumers' perceptions of written patient information, including their views on its comprehensibility, utility, and overall design quality. In the questionnaire, four perspectives will be evaluated using Likert scales, including "comprehensibility" (5 items, with a total score range from 5 to 25), "future use" (3 items, with a total score range from 3 to 15), "utility" (5 topics with two perspectives: the amount of information provided and its usefulness, with a total score range from 3 to 20.), and "design quality" (6 items, with a total score range from 6 to 30). Higher scores indicate better quality of the patient information leaflet.

  3 months

• Participants' characteristics

  Gender, age group, highest level of education, current employment status, if participant has worked in the healthcare system, Which patient information leaflet did the participant evaluate? What type of organ transplant has the participant or the person they look after received? (Kidney, liver, heart, or lung transplant), How long has it been since the transplant?

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have undergone solid organ transplantation (kidney, liver, heart, lung) or their caregivers/family members

You may qualify if:

• Patients who have undergone solid organ transplantation (kidney, liver, heart, lung)
• Caregivers or family members of organ transplant patients
• German-speaking individuals
• adult

You may not qualify if:

• Individuals who are not able to provide consent
• Non-German-speaking individuals
• under 18 years old
• Patients who have undergone organ transplantation and are no longer taking immunosuppressants

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (1)

Institute of Pharmaceutical and Medicinal Chemistry, Clinical Pharmacy, University of Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Central Study Contacts

Li-Yun Chen

CONTACT

+49 (0) 251 83-32173; liyun.chen@uni-muenster.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 22, 2024
• Study Start: November 6, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

DE (1)