PMID- 30482739
OWN - NLM
STAT- MEDLINE
DCOM- 20190829
LR  - 20230502
IS  - 1438-8871 (Electronic)
IS  - 1439-4456 (Print)
IS  - 1438-8871 (Linking)
VI  - 20
IP  - 11
DP  - 2018 Nov 27
TI  - A Web-Based Telemanagement System for Improving Disease Activity and Quality of 
      Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized 
      Controlled Trial.
PG  - e11602
LID - 10.2196/11602 [doi]
LID - e11602
AB  - BACKGROUND: The reported efficacy of telemedicine in patients with inflammatory 
      bowel disease (IBD) is inconsistent among studies, and data for complex IBD are 
      lacking. OBJECTIVE: We aimed to evaluate the impact of remote monitoring using a 
      Web system-Telemonitorizacion de la Enfermedad de Crohn y Colitis Ulcerosa or 
      Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU)-as compared to 
      standard care and telephone care on health outcomes and health care in patients 
      with complex IBD. METHODS: We performed a 3-arm randomized controlled trial. 
      Adult patients with IBD who received immunosuppressants and biological agents 
      were recruited from the IBD Unit of a tertiary university hospital. The patients 
      were randomized into groups to receive remote monitoring (G_TECCU), 
      nurse-assisted telephone care (G_NT), or standard care with in-person visits 
      (G_control). All patients completed the study visits at baseline and at 12 and 24 
      weeks in addition to each type of intervention. The primary outcome was the 
      percentage of patients in remission at 24 weeks. Secondary health outcomes were 
      quality of life, medication adherence, adverse effects, satisfaction, and social 
      activities. Data on the number of outpatient visits and telephone calls, 
      emergency visits, hospitalizations, IBD-related surgeries, and corticosteroid 
      courses were also collected. RESULTS: A total of 63 patients were selected (21 
      patients in each group). During the study, 90.5% (19/21) of patients in 
      G_control, 95.2% (20/21) in G_NT, and 85.7% (18/21) in G_TECCU were compliant to 
      the intervention. After 24 weeks, the percentage of patients in remission was 
      higher in G_TECCU (17/21, 81%) than in G_NT (14/21, 66.7%) and G_control (15/21, 
      71.4%). A higher improvement in disease activity was observed in G_TECCU than in 
      G_control in terms of the Harvey-Bradshaw/Mayo (odds ratio=0.12, 95% 
      CI=0.003-2.162, P=.19) and Harvey-Bradshaw/Walmsley (odds ratio=0.11, 95% 
      CI=0.004-1.55, P=.13) indexes. Improvement in disease activity was associated 
      with a larger reduction in fecal calprotectin values in G_TECCU compared to 
      G_control (estimated intervention effect: odds ratio=-0.90; 95% CI=-1.96 to 0.16, 
      P=.11). All completers adhered to treatment in G_TECCU. In addition, the quality 
      of life, social activities, and satisfaction improved in all 3 groups. Although 
      the number of outpatient visits and telephone calls was lower in G_TECCU than in 
      G_NT and G_control, the safety profile was similar in all 3 groups. CONCLUSIONS: 
      This pilot clinical trial suggests that the TECCU Web-based system is a safe 
      strategy for improving health outcomes in patients with complex IBD and reducing 
      the use of health care resources. TRIAL REGISTRATION: ClinicalTrials.gov 
      NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite 
      at http://www.webcitation.org/746CRRtDN).
CI  - (c)Javier Del Hoyo, Pilar Nos, Raquel Faubel, Diana Munoz, David Dominguez, 
      Guillermo Bastida, Bernardo Valdivieso, Marisa Correcher, Mariam Aguas. 
      Originally published in the Journal of Medical Internet Research 
      (http://www.jmir.org), 27.11.2018.
FAU - Del Hoyo, Javier
AU  - Del Hoyo J
AUID- ORCID: 0000-0003-3603-5793
AD  - Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, 
      Spain.
FAU - Nos, Pilar
AU  - Nos P
AUID- ORCID: 0000-0002-6619-1511
AD  - Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, 
      Spain.
AD  - CIBEREHD (Networked Biomedical Research Center for Hepatic and Digestive 
      Diseases), Valencia, Spain.
AD  - Health Research Institute La Fe, Valencia, Spain.
FAU - Faubel, Raquel
AU  - Faubel R
AUID- ORCID: 0000-0002-8716-8003
AD  - Physiotherapy Department, University of Valencia, Valencia, Spain.
AD  - Joint Research Unit in Biomedical Engineering (eRPSS: IIS La Fe-UPV), Valencia, 
      Spain.
FAU - Munoz, Diana
AU  - Munoz D
AUID- ORCID: 0000-0003-0723-7927
AD  - Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, 
      Spain.
FAU - Dominguez, David
AU  - Dominguez D
AUID- ORCID: 0000-0001-9172-4503
AD  - Connected Health Services, Valencia, Spain.
FAU - Bastida, Guillermo
AU  - Bastida G
AUID- ORCID: 0000-0001-7544-451X
AD  - Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, 
      Spain.
AD  - CIBEREHD (Networked Biomedical Research Center for Hepatic and Digestive 
      Diseases), Valencia, Spain.
AD  - Health Research Institute La Fe, Valencia, Spain.
FAU - Valdivieso, Bernardo
AU  - Valdivieso B
AUID- ORCID: 0000-0003-3344-2369
AD  - Joint Research Unit in Biomedical Engineering (eRPSS: IIS La Fe-UPV), Valencia, 
      Spain.
AD  - Home Care and Telemedicine Department, La Fe University and Polytechnic Hospital, 
      Valencia, Spain.
AD  - Red de Investigacion en Servicios de Salud en Enfermedades Cronicas (REDISSEC), 
      Madrid, Spain.
FAU - Correcher, Marisa
AU  - Correcher M
AUID- ORCID: 0000-0003-1856-4851
AD  - Systems Department, La Fe University and Polytechnic Hospital, Valencia, Spain.
FAU - Aguas, Mariam
AU  - Aguas M
AUID- ORCID: 0000-0003-4353-569X
AD  - Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, 
      Spain.
AD  - CIBEREHD (Networked Biomedical Research Center for Hepatic and Digestive 
      Diseases), Valencia, Spain.
AD  - Health Research Institute La Fe, Valencia, Spain.
LA  - eng
SI  - ClinicalTrials.gov/NCT02943538
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181127
PL  - Canada
TA  - J Med Internet Res
JT  - Journal of medical Internet research
JID - 100959882
SB  - IM
MH  - Adult
MH  - Colitis, Ulcerative/*psychology/*therapy
MH  - Crohn Disease/*psychology/*therapy
MH  - Female
MH  - Humans
MH  - Inflammatory Bowel Diseases/*psychology/*therapy
MH  - Internet
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Quality of Life/*psychology
MH  - Telemedicine/*methods
MH  - Young Adult
PMC - PMC6301812
OTO - NOTNLM
OT  - Crohn disease
OT  - e-health
OT  - inflammatory bowel disease
OT  - information and communication technology
OT  - telemedicine
OT  - ulcerative colitis
COIS- Conflicts of Interest: DD is the general manager of Connected Health Services.
EDAT- 2018/11/30 06:00
MHDA- 2019/08/30 06:00
PMCR- 2018/11/27
CRDT- 2018/11/29 06:00
PHST- 2018/07/23 00:00 [received]
PHST- 2018/10/22 00:00 [accepted]
PHST- 2018/10/09 00:00 [revised]
PHST- 2018/11/29 06:00 [entrez]
PHST- 2018/11/30 06:00 [pubmed]
PHST- 2019/08/30 06:00 [medline]
PHST- 2018/11/27 00:00 [pmc-release]
AID - v20i11e11602 [pii]
AID - 10.2196/11602 [doi]
PST - epublish
SO  - J Med Internet Res. 2018 Nov 27;20(11):e11602. doi: 10.2196/11602.