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Telemedicine has shown promise in inflammatory bowel disease (IBD). The objective of this study was to compare disease activity and quality of life (QoL) in a 1-year randomized trial of IBD patients receiving telemedicine vs. standard care. Patients with worsening symptoms in the prior 2 years were eligible for randomization to telemedicine (monitoring via texts EOW or weekly) or standard care. The primary outcomes were the differences in change in disease activity and QoL between the groups; change in healthcare utilization among groups was a secondary aim. 348 participants were enrolled (117 control group, 115 TELE-IBD EOW, and 116 TELE-IBD weekly). 259 (74.4%) completed the study. Age was 38.9 ± 12.3 years, 56.6% were women, 91.9% were Caucasian, 67.9% had Crohn's disease (CD) and 42.5% had active disease at baseline. In CD, all groups experienced a decrease in disease activity (control -5.2 ± 5.0 to 3.7 ± 3.6, TELE-IBD EOW 4.7 ± 4.1 to 4.2 ± 3.9, and TELE-IBD weekly 4.2 ± 4.2 to 3.2 ± 3.4, p < 0.0001 for each of the groups) In UC, only controls had a significant decrease in disease activity (control 2.9 ± 3.1 to 1.4 ± 1.4, p = 0.01, TELE-IBD EOW 2.7 ± 3.1 to 1.7 ± 1.9, p = 0.35, and TELE-IBD Weekly 2.5 ± 2.5 to 2.0 ± 1.8, p = 0.31). QoL increased in all groups; the increase was significant only in TELE-IBD EOW (control 168.1 ± 34.0 to 179.3 ± 28.2, p = 0.06, TELE-IBD EOW 172.3 ± 33.1 to 181.5 ± 28.2, p = 0.03, and TELE-IBD Weekly 172.3 ± 34.5 to 179.2 ± 32.8, p = 0.10). Unadjusted and adjusted changes in disease activity and QoL were not significantly different among groups. Healthcare utilization increased in all groups. TELE-IBD weekly were less likely to have IBD-related hospitalizations and more likely to have non-invasive diagnostic tests and electronic encounters compared to controls; both TELE-IBD groups had decreased non-IBD related hospitalizations and increased telephone calls compared to controls. Disease activity and QoL, although improved in all participants, were not improved further through use of the TELE-IBD system. TELE-IBD participants experienced a decrease in hospitalizations with an associated increase in non-invasive diagnostic tests, telephone calls and electronic encounters. Research is needed to determine if TELE-IBD can be improved through patient engagement and whether it can decrease healthcare utilization by replacing standard care.

Inflammatory bowel disease (IBD), comprising Crohn disease and ulcerative colitis, affects 1 to 3 million people in the United States. Telemedicine has shown promise in IBD. The objective of this study, telemedicine for patients with IBD (TELE-IBD), was to compare disease activity and quality of life (QoL) in a 1-year randomized clinical trial of IBD patients receiving telemedicine versus standard care. Treatment groups experienced improvements in disease activity and QoL, but there were no significant differences between groups. Study adherence to the text-based intervention was less than 80%, the targeted goal. To understand adherence to remote monitoring, the goal of this qualitative assessment was to obtain TELE-IBD trial participants' perceptions, including their recommendations for future monitoring. In this study, patients attending 3 tertiary referral centers with worsening IBD symptoms in the previous 2 years were eligible for randomization to remote monitoring via SMS text messages (short message service, SMS) every other week, weekly, or standard care. Participants (n=348) were evenly enrolled in the treatment groups, and 259 (74.4%) completed the study. For this study, a purposive sample of adherent (N=15) and nonadherent (N=14) patients was drawn from the TELE-IBD trial population. Adherence was defined as the completion of 80% (278/348) or more of the weekly or every other week self-assessments. Semistructured interviews conducted by phone surveyed (1) the strengths and benefits of TELE-IBD, (2) challenges associated with using TELE-IBD, and (3) how to improve the TELE-IBD intervention. Interviews were recorded, professionally transcribed, and coded based on a priori concepts and emergent themes with the aid of ATLAS.ti, version.7 qualitative data analysis software. Participants' discussions centered on 3 elements of the intervention: (1) self-assessment questions, (2) action plans, and (3) educational messages. Participants also commented on text-based platform, depression and adherence, TELE-IBD system in place of office visit, and their recommendations for future TELE-IBD systems. Adherent and nonadherent participants prefer a flexible system that is personalized, including targeted education messages, and they perceive the intervention as effective in facilitating IBD self-management. Participants identified clear benefits to the TELE-IBD system, including obtaining a better understanding of the disease process, monitoring their symptoms, and feeling connected to their health care provider. Participants' perceptions obtained in this qualitative study will assist in improving the TELE-IBD system to be more responsive to patients with IBD.

IntroductionLimitations in inflammatory bowel disease (IBD) care necessitate greater patient activation and self-efficacy, measures associated with positive health outcomes.MethodsWe assessed change in patient activation and general self-efficacy from baseline to 12 months through our TELEmedicine for IBD trial, a multicenter, randomized controlled trial consisting of a web-based monitoring system that interacts with participants via text messaging. A total of 222 adults with IBD who had experienced an IBD flare within 2 years prior to the trial were randomized into either a control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W).ResultsChanges in self-efficacy scores were not significantly different between control and experimental groups. Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03).ConclusionsUse of remote monitoring did not improve self-efficacy or patient activation compared to routine care.

BackgroundIn our clinical practice, women often report excess weight gain with infliximab (IFX) use. There are currently no studies investigating weight gain after antitumor necrosis factor therapy in patients with inflammatory bowel disease. The objective of this study was to evaluate the association of clinical factors, with a particular focus on sex and weight gain in patients with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC) initiating IFX.MethodsData was extracted from ACCENT I, ACCENT II, ACT 1, and SONIC; included patients received IFX for induction or maintenance of remission of CD or UC. Patients treated with azathioprine (IFX 0 mg/kg) were included as controls. Baseline demographics, clinical characteristics, and weight at each follow-up for the study duration were collected. In addition to descriptive statistics, adjusted mixed effects models were used to test the association between clinical variables and weight gain.ResultsThere were 1273 patients included for analysis; the majority was white (91%), with CD (81%), and half of patients (50%) were women. Upon univariate analysis, IFX dose, African American race, diagnosis of CD, elevated C-reactive protein, and low hematocrit and albumin were associated with weight gain (P < 0.001). Upon adjusted analysis, sex was significantly associated with weight gain (P = 0.009), with women experiencing a lower percentage increase from baseline weight than men (3.9% increase vs 4.3% increase).ConclusionsWhen starting IFX, those with markers of severe disease and with a diagnosis of CD are likely to gain more weight. Adjusting for confounding variables, women actually gain less weight than men after IFX treatment, although this difference is not clinically relevant.

Abstract Background Effective treatments are available for patients with inflammatory bowel disease (IBD); however, suboptimal outcomes occur and are often linked to patients' limited disease knowledge. The aim of this analysis was to determine if delivery of educational messages through a telemedicine system improves IBD knowledge. Methods TELEmedicine for Patients with IBD (TELE-IBD) was a randomized controlled trial with visits at baseline, 6 months, and 12 months; patient knowledge was a secondary aim of the study. Patients were randomized to receive TELE-IBD every other week (EOW), weekly (TELE-IBD W), or standard of care. Knowledge was assessed at each visit with the Crohn's and Colitis Knowledge (CCKNOW) survey. The primary outcome was change in CCKNOW score over 1 year compared between the TELE-IBD and control groups. Results This analysis included 219 participants. Participants in the TELE-IBD arms had a greater improvement in CCKNOW score compared with standard care (TELE-IBD EOW +2.4 vs standard care +1.8, P = 0.03; TELE-IBD W +2.0 vs standard care +1.8, P = 0.35). Participants with lower baseline CCKNOW scores had a greater change in their score over time (P < 0.01). However, after adjusting for race, site, and baseline knowledge, there was no difference in CCKNOW score change between the control and telemedicine arms. Conclusions Telemedicine improves IBD-specific knowledge through text messaging, although the improvement is not additive with greater frequency of text messages. However, after adjustment for confounding variables, telemedicine is not superior to education given through standard visits at referral centers. Further research is needed to determine if revised systems with different modes of delivery and/or frequency of messages improve disease knowledge.

This manuscript is a secondary analysis of a large multicenter randomized controlled trial. The primary study is Cross RK et al., A Randomized Controlled Trial of TELEmedicine for patients with Inflammatory Bowel Disease (TELE-IBD). Am J Gastroenterol, 2019 Mar.

Abstract Background Depression is common in patients with inflammatory bowel disease (IBD) and is known to be associated with poor adherence in the usual care setting. In the last decade, there has been an increase in the use of information technology (IT) for the delivery of IBD care, but the association between depressive symptoms (DS) and adherence to self-testing in this context is not known. We aimed to investigate this association among IBD patients managed via a text messaging-based telemedicine system. Methods This was a prospective study of participants in the 2 intervention arms of the Telemedicine for Patients with IBD (TELE-IBD) trial. Depressive symptoms were measured at baseline, and then participants received periodic text messages to initiate IBD-specific self-testing. Treatment plans were similarly conveyed, and adherence to self-testing was evaluated at the end of 1 year. Regression analyses were performed, and age-stratified models were constructed to evaluate for effect modification. Results Of the 193 study participants, 48% had DS at baseline. Overall, there was no significant association between DS and adherence to self-testing. However, upon stratification by age, adherence increased with depressive symptoms in those that were 40 years and younger (P = 0.02), but there was no association between depressive symptoms and adherence in the older group (P = 0.53). Conclusions Younger IBD patients with DS have high adherence when managed in a text messaging-based telemedicine program. Telemedicine interventions have the potential to improve health outcomes in this demographic-a group that is often thought to be difficult to manage due to nonadherence.

Abstract Inflammatory bowel disease (IBD) is a chronic debilitating condition involving the gastrointestinal (GI) tract that has a negative impact on quality of life (QoL). Depressive symptoms (DS) are common in affected patients and contribute to decreased QoL. Telemedicine is the use of information technology to remotely deliver health care; it is poised to gain widespread use in the care of IBD patients. However, its effect on DS and QoL is unknown in IBD. We investigated the impact of telemedicine on DS and QoL over time. This was a one-year, multicenter, randomized, controlled trial evaluating disease activity and QoL in IBD patients using text message-based telemedicine. Participants were randomized to three groups: standard of care and telemedicine weekly or every other week (EOW). Using mobile phones, telemedicine participants relayed information on their clinical symptoms and treatment plans were similarly conveyed to them. DS and QoL were measured using the Mental Health Inventory (MHI-5) and Short Form (SF-12) respectively. The SF-12 score has a physical component score (PCS) and a mental component score (MCS). Change in MHI-5 and SF-12 scores from baseline to 12 months was assessed, and comparison was made between the intervention and control groups. Of the 217 study participants, 59% were woman and 69% had Crohn’s disease. The number of participants in the control, telemedicine weekly and EOW groups were 72, 71, and 74 respectively. The baseline PCS, MCS, and MHI-5 scores were 46.9, 48.6, and 74.9 for all participants. Increase in mean PCS (p=0.0003) and MCS (p=0.04) was significant in the standard of care group over the study period. After controlling for confounding variables, there was no significant difference in the mean change in PCS (p=0.06), MCS (p=0.89), and MHI-5 (p=0.70) scores among the standard of care, weekly and EOW telemedicine groups. Text message-based telemedicine does not lead to improvement of DS or QoL when compared to standard of care in IBD patients. Although telemedicine has been shown to reduce healthcare utilization and improve access to care, caution should be exercised in overstating its benefits with regards to outcomes such as DS and QoL. Future studies should explore the impact of telemedicine on DS and QoL in other settings such as community practices.