Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial
Introduction Rheumatoid arthritis (RA) generally requires lifelong treatment; however, its medication complexity might affect non-adherence. Pharmacist-led telehealth services were as effective as face-to-face services and reduced potential side effects in outpatients with chronic diseases. This stu...
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| Format: | Article |
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e061917.full |
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| author | Jung-Yoon Choe Hwajeong Lee Yun-Kyoung Song Seong-Kyu Kim Ji-Won Kim Ji-Eun Park Ju-Eun Lee Bo-Kyung Moon Sung-Hoon Park |
| author_facet | Jung-Yoon Choe Hwajeong Lee Yun-Kyoung Song Seong-Kyu Kim Ji-Won Kim Ji-Eun Park Ju-Eun Lee Bo-Kyung Moon Sung-Hoon Park |
| author_sort | Jung-Yoon Choe |
| collection | DOAJ |
| description | Introduction Rheumatoid arthritis (RA) generally requires lifelong treatment; however, its medication complexity might affect non-adherence. Pharmacist-led telehealth services were as effective as face-to-face services and reduced potential side effects in outpatients with chronic diseases. This study aims to analyse the effect of a telepharmacy service with a customised mobile device in comparison with the usual pharmacist service on the humanistic and clinical outcomes in patients with RA.Methods and analysis The study is designed as a prospective, randomised, open-label, and controlled trial to compare the humanistic and clinical outcomes of the pharmaceutical care service with monthly telecommunications and a customised mobile application (telepharmacy care group) against the usual service by community pharmacists (usual care group) in 256 patients with RA and prescribed at least one of the disease-modifying antirheumatic drugs. Participants will be recruited from a tertiary hospital in Republic of Korea with written informed consent. The primary outcome will be the changes in health-related quality of life as measured by the Korean version of the EuroQoL’s five-dimensional questionnaire at 6 months compared with baseline. The secondary outcomes will be the changes in the following: scores of the Korean version of the Compliance Questionnaire-Rheumatology and medication knowledge at 3 and 6 months compared with baseline; scores of the Korean version of the Pharmacy Service Questionnaire at 6 months compared with baseline; clinical parameters such as erythrocyte sedimentation rate, C reactive protein level, and pain score at 3 and 6 months compared with baseline; frequency of acute care utilisation over 6 months. Analysis will be carried out with intent-to-treat and per-protocol principles.Ethics and dissemination The study protocol was reviewed and approved by the Institutional Review Board (IRB) of Daegu Catholic University Medical Center (IRB no. CR-21-082-L, 14 July 2021). The study findings will be published in peer-reviewed journals.Trial registration number KCT0006508. |
| format | Article |
| id | doaj-art-2f896df536c24261ad90614fcef95e2e |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2f896df536c24261ad90614fcef95e2e2025-01-24T19:40:13ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-061917Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trialJung-Yoon Choe0Hwajeong Lee1Yun-Kyoung Song2Seong-Kyu Kim3Ji-Won Kim4Ji-Eun Park5Ju-Eun Lee6Bo-Kyung Moon7Sung-Hoon Park8Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South KoreaPathology and Laboratory Medicine, Albany Medical Center, Albany, New York, USACollege of Pharmacy, The Catholic University of Korea-Sungsim Campus, Bucheon, Gyeonggido, Korea (the Republic of)Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South KoreaDivision of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea (the Republic of)KM Data Division, Korea Institute of Oriental Medicine, Daejeon, South KoreaDepartment of Pharmacy, Daegu Catholic University Medical Center, Daegu, South KoreaDepartment of Pharmacy, Daegu Catholic University Medical Center, Daegu, South KoreaDivision of Rheumatology, Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, South KoreaIntroduction Rheumatoid arthritis (RA) generally requires lifelong treatment; however, its medication complexity might affect non-adherence. Pharmacist-led telehealth services were as effective as face-to-face services and reduced potential side effects in outpatients with chronic diseases. This study aims to analyse the effect of a telepharmacy service with a customised mobile device in comparison with the usual pharmacist service on the humanistic and clinical outcomes in patients with RA.Methods and analysis The study is designed as a prospective, randomised, open-label, and controlled trial to compare the humanistic and clinical outcomes of the pharmaceutical care service with monthly telecommunications and a customised mobile application (telepharmacy care group) against the usual service by community pharmacists (usual care group) in 256 patients with RA and prescribed at least one of the disease-modifying antirheumatic drugs. Participants will be recruited from a tertiary hospital in Republic of Korea with written informed consent. The primary outcome will be the changes in health-related quality of life as measured by the Korean version of the EuroQoL’s five-dimensional questionnaire at 6 months compared with baseline. The secondary outcomes will be the changes in the following: scores of the Korean version of the Compliance Questionnaire-Rheumatology and medication knowledge at 3 and 6 months compared with baseline; scores of the Korean version of the Pharmacy Service Questionnaire at 6 months compared with baseline; clinical parameters such as erythrocyte sedimentation rate, C reactive protein level, and pain score at 3 and 6 months compared with baseline; frequency of acute care utilisation over 6 months. Analysis will be carried out with intent-to-treat and per-protocol principles.Ethics and dissemination The study protocol was reviewed and approved by the Institutional Review Board (IRB) of Daegu Catholic University Medical Center (IRB no. CR-21-082-L, 14 July 2021). The study findings will be published in peer-reviewed journals.Trial registration number KCT0006508.https://bmjopen.bmj.com/content/12/6/e061917.full |
| spellingShingle | Jung-Yoon Choe Hwajeong Lee Yun-Kyoung Song Seong-Kyu Kim Ji-Won Kim Ji-Eun Park Ju-Eun Lee Bo-Kyung Moon Sung-Hoon Park Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial BMJ Open |
| title | Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial |
| title_full | Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial |
| title_fullStr | Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial |
| title_full_unstemmed | Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial |
| title_short | Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial |
| title_sort | impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device the proud trial study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/6/e061917.full |
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