OP26 Impact of telemonitoring with TECCU on the management of Inflammatory Bowel Disease in Spain: a GETECCU clinical trial
Aguas Peris, M.(1,2)*;Del Hoyo, J.(1,2);Vicente, R.(3,4);Barreiro-de Acosta, M.(5);Melcarne, L.(6);Hernández-Camba, A.(7);Alfambra, E.(8,9);Madero, L.(10,11);Sicilia, B.(12);Chaparro, M.(13,14,15,16);Martín-Arranz, M.D.(14,17,18);Pajares, R.(19);Mesonero, F.(20);Mañosa, M.(16,21);Martínez, P.(22);Chacón , S.(23);Tosca, J.(24);Marín, S.(25,26);Sanromán, L.(27,28,29,30);Calvo, M.(31);Monfort, D.(32);Saiz, E.(33);Zabana, Y.(16,34);Guerra, I.(35);Varela, P.(36);Faubel, R.(37,38,39);Corsino, P.(3,4);Porto-Silva, S.(5);Brunet, E.(6);Gutiérrez, A.(10,11,16);Nos, P.(1,2);
(1)La Fe University and Polytechnic Hospital, Gastroenterology, Valencia, Spain;(2)Health Research Institute La Fe, IISLaFe, Valencia, Spain;(3)Miguel Servet University Hospital, Gastroenterology, Zaragoza, Spain;(4)Health Research Institute of Aragon, IIS Aragón, Zaragoza, Spain;(5)Santiago Clinic University Hospital, Gastroenterology, Santiago, Spain;(6)Parc Taulí Health Corporation, Gastroenterology, Sabadell, Spain;(7)Nuestra Señora de la Candelaria University Hospital, Gastroenterology, Tenerife, Spain;(8)Lozano Blesa Clinic University Hospital, Gastroenterology, Zaragoza, Spain;(9)IIS Aragón, Health Research Institute of Aragon IIS Aragon, Zaragoza, Spain;(10)Dr. Balmis General University Hospital, Gastroenterology, Alicante, Spain;(11)ISABIAL, Institute of Sanitary and Biomedical Research of Alicante, Alicante, Spain;(12)Burgos University Hospital, Gastroenterology, Burgos, Spain;(13)La Princesa University Hospital, Gastroenterology, Madrid, Spain;(14)Universidad Autónoma de Madrid, Faculty of Medicine, Madrid, Spain;(15)Princess Health Research Institute IIS-IP, IIS-La Princesa, Madrid, Spain;(16)Network Biomedical Research Center-ISCIII, CIBERehd, Madrid, Spain;(17)La Paz University Hospital, Gastroenterology, Madrid, Spain;(18)Investigación Sanitaria del Hospital Universitario La Paz, IdiPAZ, Madrid, Spain;(19)Infanta Sofía University Hospital, Gastroenterology, Madrid, Spain;(20)Ramón y Cajal University Hospital, Gastroenterology, Madrid, Spain;(21)Germans Trias i Pujol University Hospital-, Gastroenterology, Madrid, Spain;(22)San Cecilio Clinic University Hospital and Parque Tecnológico de la Salud, Gastroenterology, Granada, Spain;(23)Morales Meseguer General University Hospital, Gastroenterology, Murcia, Spain;(24)Clinic University Hospital, Gastroenterology, Valencia, Spain;(25)Reina Sofía University Hospital, Gastroenterology, Córdoba, Spain;(26)IMIBIC, Maimonides Institute for Biomedical Research of Córdoba, Córdoba, Spain;(27)Xerencia Xestion Integrada de Vigo-, Gastroenterology, Vigo, Spain;(28)IISGS, Galicia Sur Health Research Institute, Vigo, Spain;(29)Research Group in Digestive Diseases-, Digestive Diseases-, Vigo, Spain;(30)SERGAS, Galician Health Service, Vigo, Spain;(31)Puerta de Hierro University Hospital, Gastroenterology, Madrid, Spain;(32)Consorci Sanitari Terrasa-, Consorci Sanitari Terrasa-, Barcelona, Spain;(33)Xarxa Assistencial University Hospital, Gastroenterology, Manresa, Spain;(34)Mútua Terrassa University Hospital-, Gastroenterology, Barcelona, Spain;(35)Fuenlabrada University Hospital-, Gastroenterology, Fuenlabrada, Spain;(36)Cabueñes Universitary Hospital, Gastroenterology, Gijón, Spain;(37)ICT Applied to Reengineering Socio-Sanitary Process, Joint Research Unit, Valencia, Spain;(38)PTinMOTION-Physiotherapy in Motion Multispeciality Research Group- Universitat de València, Department of Physiotherapy, Valencia, Spain;(39)IIS La Fe-Universitat Politècnica de València, IISlaFe, Valencia, Spain;
Background
Telemedicine is not consistently superior to standard care in the management of inflammatory bowel disease (IBD). Non-inferiority is an acceptable outcome if telemedicine improves the efficacy and efficiency of care. Owing to the positive results of the TECCU app (Telemonitoring of Crohn’s Disease [CD] and Ulcerative Colitis [Au]) in a pilot trial1, we aimed to evaluate the time in remission and quality of life (QoL) of IBD patients controlled by telemonitoring (G_TECCU), compared to standard care (G_Control) after 12 weeks.
1Del Hoyo J et al. J Med Internet Res. 2018;20(11):e11602.
Methods
A 2-arm randomized multicenter study with a non-inferiority design was performed in 29 IBD centers in Spain. Adult IBD patients who initiated therapy with immunosuppressant or biological agents for disease activity were included. Exclusion criteria were: patients with ileorectal/ileo-pouch anal anastomosis, stoma, active perianal disease, no Internet access. Time in remission was evaluated with Harvey-Bradshaw/Walmsley indexes (according to CD]/UC, respectively), fecal calprotectin (FC) and reactive C protein (RCP). QoL was assessed with IBDQ-9, medication adherence with Morisky-Green index and patient satisfaction with a questionnaire derived from CSQ-8.
Results
We included 157 patients, and 126 were analyzed after 12 weeks of follow-up. The demographic and clinical variables are listed in Table 1. The time in remission was not inferior in patients who used the TECCU app (mean 4.2 weeks [SD 3.8]) compared with patients who received standard care (mean 4.2 weeks [SD 3.2]; difference 0.03 [95%CI -1.21 to 1.27]; p=0.017) (Figure 1). In patients with UC, disease activity improved significantly in both TECCU (mean SCCAI improvement -3.60 [SD 3.25]; p= 0.001) and standard care groups (-3.89 [SD 4.56]; p=0.001;). In patients with CD, clinical activity also improved significantly in both groups (mean Harvey-Bradshaw improvement -1.65 [SD 2.51]; p=0.001 in TECCU; -2.24 [SD 4.15]; p=0.001 in standard care group). Similarly, FC and CRP values improved significantly in both groups (Figure 2). Considering QoL, the IBDQ-9 score improved significantly in TECCU (mean 11.29 [SD15.8]; p<0.001) and standard care groups (16.59 [SD 22.1]; p<0.001). Medication adherence improved significantly in TECCU group and it was superior compared with standard care (Figure 3). Patient satisfaction was superior to 90% in both groups at week 12.
Conclusion
In IBD patients who initiate biological agents or immunomodulators, TECCU app is not inferior to standard care to maintain remission in the short-term. Telemonitoring with TECCU app associated a higher improvement in medication adherence and an increase in QoL. Long-term results are needed to confirm it.