{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:46:48Z","timestamp":1787024808732,"version":"build-2736575974"},"reference-count":33,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Long-term intravitreal anti\u2013vascular endothelial growth factor therapy is the gold standard for treating diabetic macular edema (DME). However, poor treatment adherence in real-world settings often leads to suboptimal visual outcomes. Evidence-based remote management strategies are required to bridge the gap between clinical protocols and patient self-management.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aims to describe a remote management program based on the Behavior Change Wheel model designed to increase treatment adherence and improve disease outcomes for patients with DME receiving long-term anti\u2013vascular endothelial growth factor therapy, and to report the study protocol.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The RE-SHINE study was structured into three phases: theoretical modeling, digital platform development, and a validation cohort study. The intervention included a smartphone-based app providing personalized health education, self-monitoring of vision (Amsler grid), injection reminders, and direct communication with health care providers. The efficacy of the remote management model was tested in a real-world cohort study. Participants were assessed at baseline and at each follow-up visit over 12 months. The primary outcome measure was best-corrected visual acuity, and secondary outcome measures included central retinal thickness and treatment adherence (injection rate and follow-up frequency).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 1006 patients with DME underwent initial screening, and 958 (95.2%) patients met the inclusion criteria, with only 7 patients declining follow-up. We anticipate that the remote management system will be both feasible and acceptable for patients with DME. It is hypothesized that the intervention group would demonstrate significantly higher levels of treatment adherence and better visual preservation compared to the retrospective control group. In addition, we intend to assess the impact of the digital intervention on patient-reported outcomes, encompassing quality of life and self-efficacy. Participant recruitment began in September 2023 and was completed by the time of submission. The data analysis is yet to begin. The results are expected to be published in 2026.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A Behavior Change Wheel\u2013based remote management approach could be a scalable and sustainable method to enhance adherence in patients requiring long-term intravitreal therapy. If proven effective, this model could be integrated into routine ophthalmic care to mitigate the risk of vision loss due to undertreatment in DME.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/85764","type":"journal-article","created":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T21:01:23Z","timestamp":1775509283000},"page":"e85764-e85764","source":"Crossref","is-referenced-by-count":1,"title":["Remote Management of Patients With Diabetic Macular Edema Receiving Long-Term Intravitreal Anti\u2013Vascular Endothelial Growth Factor Therapy (RE-SHINE Study): Protocol for a Real-World Study"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1424-911X","authenticated-orcid":false,"given":"Shu","family":"Li","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4788-7003","authenticated-orcid":false,"given":"Yupeng","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-6706-974X","authenticated-orcid":false,"given":"Yan","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4246-4343","authenticated-orcid":false,"given":"Xun","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,4,6]]},"reference":[{"issue":"3","key":"R1","doi-asserted-by":"publisher","first-page":"556","DOI":"10.2337\/dc11-1909","article-title":"Global prevalence and major risk factors of diabetic retinopathy","volume":"35","author":"Yau","journal-title":"Diabetes Care"},{"issue":"2","key":"R2","doi-asserted-by":"publisher","first-page":"e546","DOI":"10.1111\/aos.14946","article-title":"The impact of compliance among patients with diabetic macular oedema treated with intravitreal aflibercept: a 48-month follow-up study","volume":"100","author":"Angermann","journal-title":"Acta Ophthalmol"},{"key":"R3","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2018.08.026","article-title":"Conbercept for treatment of neovascular age-related macular degeneration: results of the randomized phase 3 PHOENIX study","volume":"197","author":"Liu","journal-title":"Am J Ophthalmol"},{"issue":"9","key":"R4","doi-asserted-by":"publisher","first-page":"1673","DOI":"10.1097\/IAE.0000000000002670","article-title":"Ranibizumab treatment in treatment-naive neovascular age-related macular degeneration: results from LUMINOUS, a global real-world study","volume":"40","author":"Holz","journal-title":"Retina (Philadelphia, Pa)"},{"issue":"2","key":"R5","doi-asserted-by":"publisher","first-page":"234","DOI":"10.1016\/j.ophtha.2020.07.060","article-title":"Nonadherence or nonpersistence to intravitreal injection therapy for neovascular age-related macular degeneration: a mixed-methods systematic review","volume":"128","author":"Okada","journal-title":"Ophthalmology"},{"issue":"12","key":"R6","doi-asserted-by":"publisher","first-page":"2293","DOI":"10.1097\/IAE.0000000000001892","article-title":"Compliance and adherence of patients with diabetic macular edema to intravitreal anti-vascular endothelial growth factor therapy in daily practice","volume":"38","author":"Weiss","journal-title":"Retina (Philadelphia, Pa)"},{"key":"R7","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S92548","article-title":"Current barriers to treatment for wet age-related macular degeneration (wAMD): findings from the wAMD patient and caregiver survey","volume":"9","author":"Varano","journal-title":"Clin Ophthalmol"},{"issue":"1","key":"R8","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-025-12379-4","article-title":"Exploring the factors influencing the timely intravitreal anti-VEGF treatment in patients with diabetic macular edema: a qualitative interview study using the COM-B model","volume":"25","author":"Li","journal-title":"BMC Health Serv Res"},{"issue":"4","key":"R9","doi-asserted-by":"publisher","DOI":"10.3390\/informatics9040079","article-title":"Assessing usability of smartwatch digital health devices for home blood pressure monitoring among glaucoma patients","volume":"9","author":"Bhanvadia","journal-title":"Informatics (MDPI)"},{"issue":"10","key":"R10","doi-asserted-by":"publisher","DOI":"10.3390\/jcm14103317","article-title":"Telemonitoring tools for glaucoma patients: a systematic review of current trends and applications","volume":"14","author":"Jesus","journal-title":"J Clin Med"},{"issue":"1","key":"R11","doi-asserted-by":"publisher","DOI":"10.1136\/bmjhci-2023-100748","article-title":"An online glaucoma educational course for patients to facilitate remote learning and patient empowerment","volume":"30","author":"Hamid","journal-title":"BMJ Health Care Inform"},{"issue":"12","key":"R12","doi-asserted-by":"publisher","first-page":"1757","DOI":"10.1007\/s00417-008-0929-x","article-title":"The European Glaucoma Society Glaucocard project: improved digital documentation of medical data for glaucoma patients based on standardized structured international datasets","volume":"246","author":"Schargus","journal-title":"Graefes Arch Clin Exp Ophthalmol"},{"issue":"3","key":"R13","doi-asserted-by":"publisher","first-page":"313","DOI":"10.1136\/bjophthalmol-2014-305588","article-title":"Service innovation in glaucoma management: using a web-based electronic patient record to facilitate virtual specialist supervision of a shared care glaucoma programme","volume":"99","author":"Wright","journal-title":"Br J Ophthalmol"},{"issue":"12","key":"R14","doi-asserted-by":"publisher","DOI":"10.1007\/s11892-016-0813-8","article-title":"Clinical components of telemedicine programs for diabetic retinopathy","volume":"16","author":"Horton","journal-title":"Curr Diab Rep"},{"issue":"6","key":"R15","doi-asserted-by":"publisher","first-page":"823","DOI":"10.1136\/bjophthalmol-2014-305631","article-title":"Telemedicine for detecting diabetic retinopathy: a systematic review and meta-analysis","volume":"99","author":"Shi","journal-title":"Br J Ophthalmol"},{"key":"R16","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2023.1128008","article-title":"Global trends and performances in diabetic retinopathy studies: a bibliometric analysis","volume":"11","author":"Xiao","journal-title":"Front Public Health"},{"issue":"7","key":"R17","doi-asserted-by":"publisher","first-page":"722","DOI":"10.1001\/jamaophthalmol.2017.1257","article-title":"Telemedicine for diabetic retinopathy screening","volume":"135","author":"Ting","journal-title":"JAMA Ophthalmol"},{"issue":"12","key":"R18","doi-asserted-by":"publisher","first-page":"2571","DOI":"10.1016\/j.ophtha.2016.08.021","article-title":"Cost-effectiveness of a national telemedicine diabetic retinopathy screening program in Singapore","volume":"123","author":"Nguyen","journal-title":"Ophthalmology"},{"issue":"1","key":"R19","doi-asserted-by":"publisher","first-page":"42","DOI":"10.1186\/1748-5908-6-42","article-title":"The Behaviour Change Wheel: a new method for characterising and designing behaviour change interventions","volume":"6","author":"Michie","journal-title":"Implement Sci"},{"issue":"9","key":"R20","doi-asserted-by":"publisher","first-page":"1743","DOI":"10.1097\/IAE.0000000000000548","article-title":"Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice: the TWIN study","volume":"35","author":"Souied","journal-title":"Retina (Philadelphia, Pa)"},{"issue":"11","key":"R21","doi-asserted-by":"publisher","first-page":"3489","DOI":"10.1007\/s00417-022-05703-9","article-title":"Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes","volume":"260","author":"Sugimoto","journal-title":"Graefes Arch Clin Exp Ophthalmol"},{"issue":"13","key":"R22","doi-asserted-by":"publisher","first-page":"1193","DOI":"10.1056\/NEJMoa1414264","article-title":"Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema","volume":"372","author":"Diabetic Retinopathy Clinical Research Network","journal-title":"N Engl J Med"},{"issue":"1","key":"R23","doi-asserted-by":"publisher","DOI":"10.1186\/s12886-022-02482-z","article-title":"Visual outcomes of observation, macular laser and anti-VEGF in diabetic macular edema in type 1 diabetes: a real-world study","volume":"22","author":"Wirkkala","journal-title":"BMC Ophthalmol"},{"key":"R24","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S281501","article-title":"Real-world outcomes in patients with diabetic macular edema treated long term with ranibizumab (VISION Study)","volume":"14","author":"Van Aken","journal-title":"Clin Ophthalmol"},{"issue":"3","key":"R25","doi-asserted-by":"publisher","first-page":"200","DOI":"10.22608\/APO.2018413","article-title":"Visual outcomes following intravitreal ranibizumab for diabetic macular edema in a pro re nata protocol from baseline: a real-world experience","volume":"8","author":"James","journal-title":"Asia Pac J Ophthalmol (Phila)"},{"issue":"8","key":"R26","doi-asserted-by":"publisher","first-page":"1155","DOI":"10.1016\/j.ophtha.2019.03.023","article-title":"Simultaneous inhibition of angiopoietin-2 and vascular endothelial growth factor-A with faricimab in diabetic macular edema: BOULEVARD phase 2 randomized trial","volume":"126","author":"Sahni","journal-title":"Ophthalmology"},{"issue":"12","key":"R27","doi-asserted-by":"publisher","first-page":"1152","DOI":"10.1001\/jamaophthalmol.2023.5248","article-title":"Efficacy and safety of brolucizumab for diabetic macular edema: the KINGFISHER randomized clinical trial","volume":"141","author":"Singh","journal-title":"JAMA Ophthalmol"},{"issue":"16","key":"R28","doi-asserted-by":"publisher","DOI":"10.3390\/s20164527","article-title":"The potential role of sensors, wearables and telehealth in the remote management of diabetes-related foot disease","volume":"20","author":"Golledge","journal-title":"Sensors (Basel)"},{"issue":"23","key":"R29","doi-asserted-by":"publisher","first-page":"1802","DOI":"10.1161\/CIRCULATIONAHA.124.069494","article-title":"Randomized evaluation of a remote management program to improve guideline-directed medical therapy: the DRIVE trial","volume":"149","author":"Blood","journal-title":"Circulation"},{"issue":"2","key":"R30","doi-asserted-by":"publisher","first-page":"202","DOI":"10.1016\/j.pcd.2024.01.005","article-title":"Methods, rationale, and design for a remote pharmacist and navigator-driven disease management program to improve guideline-directed medical therapy in patients with type 2 diabetes at elevated cardiovascular and\/or kidney risk","volume":"18","author":"Blood","journal-title":"Prim Care Diabetes"},{"issue":"8","key":"R31","doi-asserted-by":"publisher","DOI":"10.2196\/15779","article-title":"Effectiveness of mobile app-assisted self-care interventions for improving patient outcomes in type 2 diabetes and\/or hypertension: systematic review and meta-analysis of randomized controlled trials","volume":"8","author":"Liu","journal-title":"JMIR Mhealth Uhealth"},{"key":"R32","doi-asserted-by":"publisher","DOI":"10.4103\/jehp.jehp_1204_23","article-title":"Effect of a structured health promotional program using the self-support groups on lifestyle behavior: the","volume":"13","author":"Wani","journal-title":"J Educ Health Promot"},{"key":"R33","doi-asserted-by":"publisher","DOI":"10.2196\/54940","article-title":"The impact of digital self-monitoring of weight on improving diabetes clinical outcomes: quasi-randomized study","volume":"26","author":"Fundoiano-Hershcovitz","journal-title":"J Med Internet Res"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e85764","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T17:13:56Z","timestamp":1782839636000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e85764"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,6]]},"references-count":33,"URL":"https:\/\/doi.org\/10.2196\/85764","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,6]]},"article-number":"v15i3e85764"}}