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The Effect of Mobile Application on Subcutaneous Anti-TNF Drug Administration in Ankylosing Spondylitis Patients: A Randomized Experimental Study

Year 2025,
https://doi.org/10.17049/jnursology.1430186

Abstract

Objective: This study was conducted to develop an Android mobile application for the subcutaneous (SC) administration of anti-TNF drugs in ankylosing spondylitis patients and to evaluate its effect on drug administration.

Methods: In the first stage of this randomized experimental study, a mobile application for SC anti-TNF drug therapy was developed. In the second stage, 32 patients who met the sampling criteria were randomized to mobil and booklet groups. Patients in both groups were evaluated using the Individual Identification Form, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life Scale (ASQoL) and Subcutaneous Anti-TNF Treatment Questionnaire once every 6 weeks for 6 months.

Results: In the first stage, the concordance coefficient of the five experts’ opinions on the information provided in the mobile application was calculated as W:0.272, P=.130. For both patient groups, the mean scores of BASDAI, BASFI, and ASQoL were statistically significantly lower at the last evaluation than at the first. More patients in the education booklet group had their medication applied by someone else (P=.011).

Conclusion: The mobile application developed for SC anti-TNF therapy in AS patients is highly informative and reliable, and it facilitates the administration of SC anti-TNF drugs to patients.

Project Number

2017.2_16

References

  • 1. Zhu W, He X, Cheng K, et al. Ankylosing spondylitis: etiology, pathogenesis, and treatments. Bone Res. 2019;7(22):1-16. https://doi.org/10.1038/s41413-019-0057-8
  • 2. Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023;82:19-34. https://doi.org/10.1136/ard-2022-223296
  • 3. Humphry N. The efficcy of anti-TNFs in immüne-mediated disease. EMJ Gastroenterol. 2022;11(Suppl 5):2-9. https://doi.org/10.33590/emjgastroenterol/10102824 .
  • 4. Lata M, Hettinghouse AS, Liu CJ. Targeting tumor necrosis factor receptors in ankylosing spondylitis. Ann N Y Acad Sci. 2019;1442(1):5-16. https://doi.org/10.1111/nyas.13933 .
  • 5. Jang D-i, Lee A-H, Shin H-Y, et al. The role of Tumor Necrosis Factor Alpha (TNF-α) in autoimmune disease and current TNF-α Inhibitors in Therapeutics. Int J Mol Sci. 2021;22(5):2719. https://doi.org/10.3390/ijms22052719
  • 6. Salaffi F, Di Carlo M, Farah S, et al. Adherence to subcutaneous anti-TNFα agents in patients with rheumatoid arthritis is largely influenced by pain and skin sensations at the injection site. Int J Rheum Dis. 2020;23(4):480-487. https://doi.org/10.1111/1756-185X.13803
  • 7. Tornero Molina J, López Robledillo JC, Casamira Ruiz N. Potential benefits of the self-administration of subcutaneous methotrexate with autoinjector devices for patients: A Review. Drug Health Patient Saf. 2021;29(13):81-94. https://doi.org/10.2147/DHPS.S290771
  • 8. Beauvais C, Fayet F, Rousseau A, et al. Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: A multicentre randomized clinical trial. RMD Open. 2022;8(1):e001828. https://doi.org/10.1136/rmdopen-2021-001828.
  • 9. Onishi A, Kaizu M, Shirasugi I, et al. Demographic, physical, and psychological determinants of patient experience with subcutaneous self-ınjection in patients with rheumatoid arthritis: structural equation modeling approach. Patient Prefer Adherence. 2023;17:1551-1559 https://doi.org/10.2147/PPA.S413871
  • 10. Alsaidan AA, Alsaidan OA, Mallhi TH, et al. Assessment of adherence to ınsulin ınjections among diabetic patients on basal-bolus regimen in primary and secondary healthcare centers in al-jouf region of Saudi Arabia; a descriptive analysis. J Clin Med. 2023;12(10):3474. https://doi.org/10.3390/jcm12103474
  • 11. van den Bemt, BJF, Gettings L, Domanska B, et al. A portfolio of biologic self-injection devices in rheumatology: How patient involvement in device design can improve treatment experience. Drug Delivery. 2019;26(1):384-392. https://doi.org/10.1080/10717544.2019.1587043
  • 12. Dailah HG. The influence of nurse-led interventions on diseases management in patients with diabetes mellitus: A narrative review. Healthcare 2024;12(3):352. https://doi.org/10.3390/healthcare12030352
  • 13. Liang L, Pan Y, Wu D, et al. Effects of multidisciplinary team-based nurse-led transitional care on clinical outcomes and quality of life in patients with ankylosing spondylitis. Asian Nurs Res 2019;13(2):107-114. https://doi.org/10.1016/j.anr.2019.02.004
  • 14. Wang Y, Wu T, Chen Z. Active usage of mobile health applications: Cross-sectional study. J Med Internet Res. 2021;22;23(12):e25330. https://doi.org/10.2196/25330
  • 15. Domańska B, Vansant S, Mountian I. A companion app to support rheumatology patients treated with Certolizumab Pegol: Results from a usability study. JMIR Form Res. 2020;4(7):e17373. https://doi.org/10.2196/17373
  • 16. Adshead R, Donnelly S, Shaikh M. Evaluating the patient experience of the Barts Health MySpA app for axial spondyloarthritis and psoriatic arthritis. Rheumatology, 2021;60(1):108 https://doi.org/10.1093/rheumatology/keab247.192
  • 17. Song Y, Reifsnider E, Chen Y, et al. The Impact of a theory-based health ıntervention on disease knowledge, self-efficacy, and exercise adherence among ankylosing spondylitis patients: Randomized Controlled Trial. J Med Internet Res. 2022;24(10):e38501. https://doi.org/10.2196/38501
  • 18. Çınar M, Yılmaz S, Çınar Fİ, ve ark. Romatoloji Pratiğinde Kullanılan Biyolojik İlaçların Uygulamaları. F. İ. Çınar, M. Cinar, S. Yilmaz, H. Erdem, eds. Romatoloji Hemşireliği ve Klinik Uygulamalar içinde, İstanbul:Deomed; 2016:201-233. (in Turkish)
  • 19. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Health topics: Ankylosing Spondylitis. Accessed July 6, 2024. https://www.niams.nih.gov/health-topics/ankylosing-spondylitis
  • 20. Akkoc Y, Karatepe AG, Akar S, et al. Turkish version of the bath ankylosing spondylitis disease activity index: reliability and validity. Rheumatol Int, 2005;25(4):280-284. https://doi.org/10.1007/s00296-003-0432-y
  • 21. Ozer HT, Sarpel T, Gulek B, et al. The Turkish version of the Bath Ankylosing Spondylitis Functional Index: reliability and validity. J Clin Rheumatol. 2005;24(2):123-128. https://doi.org/10.1007/s10067-004-0984-6
  • 22. Duruöz MT, Doward L, Turan Y, et al. Translation and validation of the Turkish version of the ankylosing spondylitis quality of life (ASQoL) Questionnaire. Rheumatol Int. 2013;33(11): 2717-2722. https://doi.org/10.1007/s00296-013-2796-y
  • 23. Yusoff MSB. ABC of content validation and content validity index calculation. Educ Med J. 2019;11(2):49–54. https://doi.org/10.21315/eimj2019.11.2.6
  • 24. Gökdoğan F, Kır E, Özcan A, Cerit B, Yıldırım Y, Akbal S. Eğitim kitapçıkları güvenilir mi? 2. Uluslararası & IX. Ulusal Hemşirelik Kongresi Kongre Kitabı, Antalya, Türkiye; 2003:517-21. (in Turkish)
  • 25. Devgire V, Marti AF, McKenzie L, et al. A systematic review of internet- based information for individuals with Raynaud’s phenomenon and patients with systemic sclerosis. Clin Rheumatol. 2020; 39: 2363–2367. https://doi.org/10.1007/s10067-020-05023-5
  • 26. Karakuş Z, Özer Z, Bozcuk H. The effect of web-based education on symptom management and quality of life of patients with lung cancer. International Journal of Caring Science, 2022;15(2):1483–1492. Available from;https://www.internationaljournalofcaringsciences.org/docs/63.%20karakus.pdf
  • 27. Sletvold H, Jordan S, Olsen RM. Nurse-Led Interventions to Promote Medication Adherence in Community Care: A Systematic Review. In R. M. Olsen & H. Sletvold eds., Medication Safety in Municipal Health and Care Services, Oslo:Cappelen Damm Akademisk. 2022:163–191. https://doi.org/10.23865/noasp.172.ch8
  • 28. MacIver A, Hollinger H, Carolan C. Tele-health interventions to support self-management in adults with rheumatoid arthritis: a systematic review. Rheumatol Int. 2021;41:1399-1418. https://doi.org/10.1007/s00296-021-04907-2
  • 29. Ozkaraman A, Alparslan GB, Babadağ B, Kaşifoğlu T, Baydemir C. Effect of education and telephone counseling on adherence to treatment and challenges experienced in anti-TNF-α treatment: a pilot study. Contemp Nurse. 2018;54(1):108-119. https://doi.org/10.1080/10376178.2017.1422776
  • 30. Barello S, Paolicelli D, Bergamaschi R, et al. A nurse-led, telephone-based patient support program for improving adherence in patients with relapsing-remitting multiple sclerosis using interferon beta-1a: Lessons from a consumer-based survey on adveva® PSP. Front Psychol. 2022;24(13):965229. https://doi.org/10.3389/fpsyg.2022.965229
  • 31. Roszkiewicz J, Swacha Z, Smolewska E. Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA. Pediatr Rheumatol. 2020;18(1):64. https://doi.org/10.1186/s12969-020-00455-4
  • 32. Ghil J, Zielinska A, Lee Y. Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis. Curr Med Res Opin. 2019;35(3):497–502. https://doi.org/10.1080/03007995.2018.1560211
  • 33. Lubrano E, Perrotta FM, Manara M, et al. Improvement of function and its determinants in a group of axial spondyloarthritis patients treated with TNF inhibitors: A real-life study. Rheumatol Ther. 2020;7(2):301-310. https://link.springer.com/article/10.1007/s40744-020-00197-5
  • 34. Acar Y, Can G, İlçin N. The investigation of the relationship between disease specific indexes, fatigue and quality of life in ankylosing spondylitis patients. İKÇÜSBFD. 2019;4(1):19-2. Available from; https://dergipark.org.tr/tr/download/article-file/708894
  • 35. Youssef M, El Rafey D. Impact of biologics drugs adherence on treatment outcomes and work productivity of Al Sharqia Governorate patients with Ankylosing Spondylitis. ZUMJ, 2021;27(1):104-114. https://doi.org/10.21608/zumj.2020.48238.1993

Ankilozan Spondilit Hastalarında Mobil Uygulamanın Subkütan Anti-TNF İlaç Uygulamasına Etkisi: Randomize Deneysel Bir Çalışma

Year 2025,
https://doi.org/10.17049/jnursology.1430186

Abstract

Amaç: Bu çalışma, ankilozan spondilit (AS) hastalarının subkütan (SC) anti-TNF ilaç uygulamasına yönelik bir Android mobil uygulama geliştirmek ve bu uygulamanın ilaç uygulamasına etkisini değerlendirmek amacıyla yapıldı.

Yöntemler: Bu deneysel çalışmanın ilk aşamasında SC anti-TNF ilaç tedavisine yönelik mobil bir uygulama geliştirildi. İkinci aşamada örnekleme kriterlerini karşılayan 32 hasta mobil ve kitapçık gruplarına randomize edildi. Her iki gruptaki hastalar 6 ay boyunca her 6 haftada bir Bireysel Tanıtım Formu, Bath Ankilozan Spondilit Hastalık Aktivite İndeksi (BASDAI), Bath Ankilozan Spondilit Fonksiyonel İndeksi (BASFI), Ankilozan Spondilit Yaşam Kalitesi Anketi (ASQoL) ve Subkütan Anti-TNF Tedavi Anketi kullanılarak değerlendirildi.

Bulgular: İlk aşamada 5 uzmanın mobil uygulamada sunulan bilgilere ilişkin görüşlerinin uyum katsayısı W:0,272, P=.130 olarak hesaplandı. Her iki hasta grubunda da BASDAI, BASFI ve ASQoL ortalama puanları son değerlendirmede ilk değerlendirmeye göre istatistiksel olarak anlamlı derecede düşüktü. Eğitim kitapçığı grubunda ilacını başkasına yaptıran hasta sayısı daha fazlaydı (P=.011).

Sonuç: AS hastalarında SC anti-TNF tedavisi için geliştirilen mobil uygulamanın bilgi kalitesi ve güvenilirliği yüksek olup hastaların SC anti-TNF ilaçları uygulamasını kolaylaştırmıştır.

Supporting Institution

Koç University Semahat Arsel Nursing Education and Research Center (SANERC).

Project Number

2017.2_16

References

  • 1. Zhu W, He X, Cheng K, et al. Ankylosing spondylitis: etiology, pathogenesis, and treatments. Bone Res. 2019;7(22):1-16. https://doi.org/10.1038/s41413-019-0057-8
  • 2. Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023;82:19-34. https://doi.org/10.1136/ard-2022-223296
  • 3. Humphry N. The efficcy of anti-TNFs in immüne-mediated disease. EMJ Gastroenterol. 2022;11(Suppl 5):2-9. https://doi.org/10.33590/emjgastroenterol/10102824 .
  • 4. Lata M, Hettinghouse AS, Liu CJ. Targeting tumor necrosis factor receptors in ankylosing spondylitis. Ann N Y Acad Sci. 2019;1442(1):5-16. https://doi.org/10.1111/nyas.13933 .
  • 5. Jang D-i, Lee A-H, Shin H-Y, et al. The role of Tumor Necrosis Factor Alpha (TNF-α) in autoimmune disease and current TNF-α Inhibitors in Therapeutics. Int J Mol Sci. 2021;22(5):2719. https://doi.org/10.3390/ijms22052719
  • 6. Salaffi F, Di Carlo M, Farah S, et al. Adherence to subcutaneous anti-TNFα agents in patients with rheumatoid arthritis is largely influenced by pain and skin sensations at the injection site. Int J Rheum Dis. 2020;23(4):480-487. https://doi.org/10.1111/1756-185X.13803
  • 7. Tornero Molina J, López Robledillo JC, Casamira Ruiz N. Potential benefits of the self-administration of subcutaneous methotrexate with autoinjector devices for patients: A Review. Drug Health Patient Saf. 2021;29(13):81-94. https://doi.org/10.2147/DHPS.S290771
  • 8. Beauvais C, Fayet F, Rousseau A, et al. Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: A multicentre randomized clinical trial. RMD Open. 2022;8(1):e001828. https://doi.org/10.1136/rmdopen-2021-001828.
  • 9. Onishi A, Kaizu M, Shirasugi I, et al. Demographic, physical, and psychological determinants of patient experience with subcutaneous self-ınjection in patients with rheumatoid arthritis: structural equation modeling approach. Patient Prefer Adherence. 2023;17:1551-1559 https://doi.org/10.2147/PPA.S413871
  • 10. Alsaidan AA, Alsaidan OA, Mallhi TH, et al. Assessment of adherence to ınsulin ınjections among diabetic patients on basal-bolus regimen in primary and secondary healthcare centers in al-jouf region of Saudi Arabia; a descriptive analysis. J Clin Med. 2023;12(10):3474. https://doi.org/10.3390/jcm12103474
  • 11. van den Bemt, BJF, Gettings L, Domanska B, et al. A portfolio of biologic self-injection devices in rheumatology: How patient involvement in device design can improve treatment experience. Drug Delivery. 2019;26(1):384-392. https://doi.org/10.1080/10717544.2019.1587043
  • 12. Dailah HG. The influence of nurse-led interventions on diseases management in patients with diabetes mellitus: A narrative review. Healthcare 2024;12(3):352. https://doi.org/10.3390/healthcare12030352
  • 13. Liang L, Pan Y, Wu D, et al. Effects of multidisciplinary team-based nurse-led transitional care on clinical outcomes and quality of life in patients with ankylosing spondylitis. Asian Nurs Res 2019;13(2):107-114. https://doi.org/10.1016/j.anr.2019.02.004
  • 14. Wang Y, Wu T, Chen Z. Active usage of mobile health applications: Cross-sectional study. J Med Internet Res. 2021;22;23(12):e25330. https://doi.org/10.2196/25330
  • 15. Domańska B, Vansant S, Mountian I. A companion app to support rheumatology patients treated with Certolizumab Pegol: Results from a usability study. JMIR Form Res. 2020;4(7):e17373. https://doi.org/10.2196/17373
  • 16. Adshead R, Donnelly S, Shaikh M. Evaluating the patient experience of the Barts Health MySpA app for axial spondyloarthritis and psoriatic arthritis. Rheumatology, 2021;60(1):108 https://doi.org/10.1093/rheumatology/keab247.192
  • 17. Song Y, Reifsnider E, Chen Y, et al. The Impact of a theory-based health ıntervention on disease knowledge, self-efficacy, and exercise adherence among ankylosing spondylitis patients: Randomized Controlled Trial. J Med Internet Res. 2022;24(10):e38501. https://doi.org/10.2196/38501
  • 18. Çınar M, Yılmaz S, Çınar Fİ, ve ark. Romatoloji Pratiğinde Kullanılan Biyolojik İlaçların Uygulamaları. F. İ. Çınar, M. Cinar, S. Yilmaz, H. Erdem, eds. Romatoloji Hemşireliği ve Klinik Uygulamalar içinde, İstanbul:Deomed; 2016:201-233. (in Turkish)
  • 19. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Health topics: Ankylosing Spondylitis. Accessed July 6, 2024. https://www.niams.nih.gov/health-topics/ankylosing-spondylitis
  • 20. Akkoc Y, Karatepe AG, Akar S, et al. Turkish version of the bath ankylosing spondylitis disease activity index: reliability and validity. Rheumatol Int, 2005;25(4):280-284. https://doi.org/10.1007/s00296-003-0432-y
  • 21. Ozer HT, Sarpel T, Gulek B, et al. The Turkish version of the Bath Ankylosing Spondylitis Functional Index: reliability and validity. J Clin Rheumatol. 2005;24(2):123-128. https://doi.org/10.1007/s10067-004-0984-6
  • 22. Duruöz MT, Doward L, Turan Y, et al. Translation and validation of the Turkish version of the ankylosing spondylitis quality of life (ASQoL) Questionnaire. Rheumatol Int. 2013;33(11): 2717-2722. https://doi.org/10.1007/s00296-013-2796-y
  • 23. Yusoff MSB. ABC of content validation and content validity index calculation. Educ Med J. 2019;11(2):49–54. https://doi.org/10.21315/eimj2019.11.2.6
  • 24. Gökdoğan F, Kır E, Özcan A, Cerit B, Yıldırım Y, Akbal S. Eğitim kitapçıkları güvenilir mi? 2. Uluslararası & IX. Ulusal Hemşirelik Kongresi Kongre Kitabı, Antalya, Türkiye; 2003:517-21. (in Turkish)
  • 25. Devgire V, Marti AF, McKenzie L, et al. A systematic review of internet- based information for individuals with Raynaud’s phenomenon and patients with systemic sclerosis. Clin Rheumatol. 2020; 39: 2363–2367. https://doi.org/10.1007/s10067-020-05023-5
  • 26. Karakuş Z, Özer Z, Bozcuk H. The effect of web-based education on symptom management and quality of life of patients with lung cancer. International Journal of Caring Science, 2022;15(2):1483–1492. Available from;https://www.internationaljournalofcaringsciences.org/docs/63.%20karakus.pdf
  • 27. Sletvold H, Jordan S, Olsen RM. Nurse-Led Interventions to Promote Medication Adherence in Community Care: A Systematic Review. In R. M. Olsen & H. Sletvold eds., Medication Safety in Municipal Health and Care Services, Oslo:Cappelen Damm Akademisk. 2022:163–191. https://doi.org/10.23865/noasp.172.ch8
  • 28. MacIver A, Hollinger H, Carolan C. Tele-health interventions to support self-management in adults with rheumatoid arthritis: a systematic review. Rheumatol Int. 2021;41:1399-1418. https://doi.org/10.1007/s00296-021-04907-2
  • 29. Ozkaraman A, Alparslan GB, Babadağ B, Kaşifoğlu T, Baydemir C. Effect of education and telephone counseling on adherence to treatment and challenges experienced in anti-TNF-α treatment: a pilot study. Contemp Nurse. 2018;54(1):108-119. https://doi.org/10.1080/10376178.2017.1422776
  • 30. Barello S, Paolicelli D, Bergamaschi R, et al. A nurse-led, telephone-based patient support program for improving adherence in patients with relapsing-remitting multiple sclerosis using interferon beta-1a: Lessons from a consumer-based survey on adveva® PSP. Front Psychol. 2022;24(13):965229. https://doi.org/10.3389/fpsyg.2022.965229
  • 31. Roszkiewicz J, Swacha Z, Smolewska E. Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA. Pediatr Rheumatol. 2020;18(1):64. https://doi.org/10.1186/s12969-020-00455-4
  • 32. Ghil J, Zielinska A, Lee Y. Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis. Curr Med Res Opin. 2019;35(3):497–502. https://doi.org/10.1080/03007995.2018.1560211
  • 33. Lubrano E, Perrotta FM, Manara M, et al. Improvement of function and its determinants in a group of axial spondyloarthritis patients treated with TNF inhibitors: A real-life study. Rheumatol Ther. 2020;7(2):301-310. https://link.springer.com/article/10.1007/s40744-020-00197-5
  • 34. Acar Y, Can G, İlçin N. The investigation of the relationship between disease specific indexes, fatigue and quality of life in ankylosing spondylitis patients. İKÇÜSBFD. 2019;4(1):19-2. Available from; https://dergipark.org.tr/tr/download/article-file/708894
  • 35. Youssef M, El Rafey D. Impact of biologics drugs adherence on treatment outcomes and work productivity of Al Sharqia Governorate patients with Ankylosing Spondylitis. ZUMJ, 2021;27(1):104-114. https://doi.org/10.21608/zumj.2020.48238.1993
There are 35 citations in total.

Details

Primary Language English
Subjects ​Internal Diseases Nursing​
Journal Section Research Articles
Authors

Füsun Uzgör 0000-0002-4233-7774

Ayşe Özkaraman 0000-0002-0507-4100

Cengiz Korkmaz 0000-0003-2679-0699

Project Number 2017.2_16
Early Pub Date January 6, 2025
Publication Date
Submission Date February 1, 2024
Acceptance Date November 12, 2024
Published in Issue Year 2025

Cite

AMA Uzgör F, Özkaraman A, Korkmaz C. The Effect of Mobile Application on Subcutaneous Anti-TNF Drug Administration in Ankylosing Spondylitis Patients: A Randomized Experimental Study. Journal of Nursology. Published online January 1, 2025. doi:10.17049/jnursology.1430186

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