The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial
Abstract Background Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by heal...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-10-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2221-z |
| _version_ | 1819054212759158784 |
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| author | Hee-Yeon Jung Sook Jin Seong Ji-Young Choi Jang-Hee Cho Sun-Hee Park Chan-Duck Kim Young-Ran Yoon Hyung-Kee Kim Seung Huh Se-Hee Yoon Jong Soo Lee Yong-Lim Kim |
| author_facet | Hee-Yeon Jung Sook Jin Seong Ji-Young Choi Jang-Hee Cho Sun-Hee Park Chan-Duck Kim Young-Ran Yoon Hyung-Kee Kim Seung Huh Se-Hee Yoon Jong Soo Lee Yong-Lim Kim |
| author_sort | Hee-Yeon Jung |
| collection | DOAJ |
| description | Abstract Background Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative. Methods/design This study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped with personal identification system, a home monitoring system, an electronic Case Report Form (eCRF) system, and a comprehensive clinical trial management system (CTMS). It alerts both patients and medical staff with texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Medication adherence and transplant outcomes for the follow-up period are compared between the two groups, while patient satisfaction as well as the stability and cost-effectiveness of the ICT-based monitoring system are to be evaluated. Discussion This on-going study is expected to determine if consistent use of the ICT-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs. Further, it would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs. Trials registration ClinicalTrials.gov, Identifier: NCT03136588 . Registered on 20 April 2017. |
| first_indexed | 2024-12-21T12:48:02Z |
| format | Article |
| id | doaj.art-d53891619c434a57bc17997fe893bafb |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T12:48:02Z |
| publishDate | 2017-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-d53891619c434a57bc17997fe893bafb2022-12-21T19:03:35ZengBMCTrials1745-62152017-10-0118111010.1186/s13063-017-2221-zThe efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trialHee-Yeon Jung0Sook Jin Seong1Ji-Young Choi2Jang-Hee Cho3Sun-Hee Park4Chan-Duck Kim5Young-Ran Yoon6Hyung-Kee Kim7Seung Huh8Se-Hee Yoon9Jong Soo Lee10Yong-Lim Kim11Department of Internal Medicine, Kyungpook National University School of MedicineDepartment of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and HospitalDepartment of Internal Medicine, Kyungpook National University School of MedicineDepartment of Internal Medicine, Kyungpook National University School of MedicineDepartment of Internal Medicine, Kyungpook National University School of MedicineDepartment of Internal Medicine, Kyungpook National University School of MedicineDepartment of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and HospitalDepartment of Surgery, Kyungpook National University School of MedicineDepartment of Surgery, Kyungpook National University School of MedicineDepartment of Internal Medicine, Konyang University College of MedicineDepartment of Internal Medicine, University of Ulsan College of MedicineDepartment of Internal Medicine, Kyungpook National University School of MedicineAbstract Background Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative. Methods/design This study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped with personal identification system, a home monitoring system, an electronic Case Report Form (eCRF) system, and a comprehensive clinical trial management system (CTMS). It alerts both patients and medical staff with texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Medication adherence and transplant outcomes for the follow-up period are compared between the two groups, while patient satisfaction as well as the stability and cost-effectiveness of the ICT-based monitoring system are to be evaluated. Discussion This on-going study is expected to determine if consistent use of the ICT-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs. Further, it would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs. Trials registration ClinicalTrials.gov, Identifier: NCT03136588 . Registered on 20 April 2017.http://link.springer.com/article/10.1186/s13063-017-2221-zInformation and communication technologyAdherenceKidney transplantation |
| spellingShingle | Hee-Yeon Jung Sook Jin Seong Ji-Young Choi Jang-Hee Cho Sun-Hee Park Chan-Duck Kim Young-Ran Yoon Hyung-Kee Kim Seung Huh Se-Hee Yoon Jong Soo Lee Yong-Lim Kim The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial Trials Information and communication technology Adherence Kidney transplantation |
| title | The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial |
| title_full | The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial |
| title_fullStr | The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial |
| title_full_unstemmed | The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial |
| title_short | The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial |
| title_sort | efficacy and stability of an information and communication technology based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients study protocol for a randomized controlled trial |
| topic | Information and communication technology Adherence Kidney transplantation |
| url | http://link.springer.com/article/10.1186/s13063-017-2221-z |
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