Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652919
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Survey on the Evaluation of Medication Information Leaflets for Organ Transplant Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Validation of Materials for the Pharmaceutical Care of Organ Transplant Recipients in Community Pharmacy Survey on the Evaluation of Medication Information Leaflets for Organ Transplant Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to collect feedback from organ transplant patients or their caregiversrelatives on the medication information leaflets weve developed using a questionnaire and to adjust the content to better meet the specific needs of this unique patient group
Detailed Description:
Introduction
Organ transplantation is a life-saving procedure but it also marks the beginning of a lifelong journey for patients In 2023 alone over 3600 organ transplants were performed in Germany with kidney liver heart and lung transplants being the most common Following a transplant patients must take a combination of immunosuppressive medications to prevent their body from rejecting the new organ These drugs while essential come with significant risks Many of which have a very narrow therapeutic range and a high risk of drug interactions Additionally these medications have unique side effects that can affect mortality and health-related quality of life HRQOL As a result organ transplant patients require constant medical monitoring and comprehensive education about their medications to ensure long-term graft survival and a better quality of life
Community pharmacies in Germany have recognized the need to support these patients Since 2022 community pharmacies have been offering pharmaceutical care services specifically tailored to organ transplant recipients focusing on safe medication use and personalized counseling including brown-bag reviews This service is covered by health insurance and aims to reduce administration errors improve therapy adherence and enhance overall patient safety However despite nearly 4000 new organ transplants each year only a small fraction of these patients-less than 3-benefit from these services annually The reality is that public pharmacies rarely interact with transplant patients as they make up a small group Furthermore there is currently a lack of adequate materials to support the provision of this service for transplant patients
This research project addresses this gap by developing and validating specific materials that will help pharmacies deliver high-quality pharmaceutical care to organ transplant recipients A key element of this project is the medication information leaflets designed by the investigators which aim to enhance patients understanding of their immunosuppressive therapy reduce medication use errors and ultimately improve medication safety
The aim of this study is to collect feedback from organ transplant patients or their caregiversrelatives on these medication leaflets using a questionnaire instrument called Adapted Consumer Information Rating Form CIRF developed by Krass et al The results will help the investigators evaluate the quality of the medication information leaflets in terms of their content and design This will also assist the investigators in adjusting the content to better meet the specific needs of this unique patient group in the future
Study design
This pilot study is designed as a descriptive survey It involves a one-time survey either online or in paper form that collects data on participants evaluations and opinions regarding the medication information sheets The instrument that is used the original Adapted CIRF was initially translated by the investigators through a peer review process including cultural adaptation from English to German After two rounds of peer review the final version was produced Permission for the use and translation of the original Adapted CIRF was obtained from Krass et al Additionally demographic data will be collected in the study This study was approved by the Ethics Committee Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
The recruitment of the participants will be conducted through cooperating pharmacies and patient self-help groups and participation in the questionnaire is voluntary Data protection measures will be taken into account to ensure the confidentiality and security of participants information
Procedure for participation in the study
1 The study begins as soon as the participants have agreed to the consent form
2 The study consists of two parts In Part 1 participants are asked to select a medication information sheet and thoroughly read it
3 In Part 2 participants will ask to complete the questionnaire
4 After completing the questionnaire the participation is considered finished The process will take approximately 10 to 20 minutes
Organ transplantation is a life-saving procedure but it also marks the beginning of a lifelong journey for patients In 2023 alone over 3600 organ transplants were performed in Germany with kidney liver heart and lung transplants being the most common Following a transplant patients must take a combination of immunosuppressive medications to prevent their body from rejecting the new organ These drugs while essential come with significant risks Many of which have a very narrow therapeutic range and a high risk of drug interactions Additionally these medications have unique side effects that can affect mortality and health-related quality of life HRQOL As a result organ transplant patients require constant medical monitoring and comprehensive education about their medications to ensure long-term graft survival and a better quality of life
Community pharmacies in Germany have recognized the need to support these patients Since 2022 community pharmacies have been offering pharmaceutical care services specifically tailored to organ transplant recipients focusing on safe medication use and personalized counseling including brown-bag reviews This service is covered by health insurance and aims to reduce administration errors improve therapy adherence and enhance overall patient safety However despite nearly 4000 new organ transplants each year only a small fraction of these patients-less than 3-benefit from these services annually The reality is that public pharmacies rarely interact with transplant patients as they make up a small group Furthermore there is currently a lack of adequate materials to support the provision of this service for transplant patients
This research project addresses this gap by developing and validating specific materials that will help pharmacies deliver high-quality pharmaceutical care to organ transplant recipients A key element of this project is the medication information leaflets designed by the investigators which aim to enhance patients understanding of their immunosuppressive therapy reduce medication use errors and ultimately improve medication safety
The aim of this study is to collect feedback from organ transplant patients or their caregiversrelatives on these medication leaflets using a questionnaire instrument called Adapted Consumer Information Rating Form CIRF developed by Krass et al The results will help the investigators evaluate the quality of the medication information leaflets in terms of their content and design This will also assist the investigators in adjusting the content to better meet the specific needs of this unique patient group in the future
Study design
This pilot study is designed as a descriptive survey It involves a one-time survey either online or in paper form that collects data on participants evaluations and opinions regarding the medication information sheets The instrument that is used the original Adapted CIRF was initially translated by the investigators through a peer review process including cultural adaptation from English to German After two rounds of peer review the final version was produced Permission for the use and translation of the original Adapted CIRF was obtained from Krass et al Additionally demographic data will be collected in the study This study was approved by the Ethics Committee Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
The recruitment of the participants will be conducted through cooperating pharmacies and patient self-help groups and participation in the questionnaire is voluntary Data protection measures will be taken into account to ensure the confidentiality and security of participants information
Procedure for participation in the study
1 The study begins as soon as the participants have agreed to the consent form
2 The study consists of two parts In Part 1 participants are asked to select a medication information sheet and thoroughly read it
3 In Part 2 participants will ask to complete the questionnaire
4 After completing the questionnaire the participation is considered finished The process will take approximately 10 to 20 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None