Introduction

The use of mobile Health applications (mHealth apps) is increasingly frequent as telehealth provides clinical support for patients with chronic pathologies, including health education, symptom surveillance, follow-up, and promotes therapeutic adherence and compliance. There are mHealth apps directed to patients with inflammatory bowel disease (IBD) that have shown to significantly improve IBD disease knowledge level, therapeutic adherence, and even quality of life. Nevertheless, the vast majority is not available in Spanish, thus have limited access and use, no documented validation or user-patient acceptance test (UAT), little multifunctionality and/or difficulty handling.

Aims & Methods

We developed a multifunctional and intuitive free access mHealth app directed to Spanish speakers with IBD and we aimed to validate it with a UAT. The Development and Assessment of a Mobile Application for Sanitary Support in Spanish speakers with Crohn’s and ulcerative Colitis (DAMASCO) is an independent and multicenter project in Latin America. It is an observational, analytic, and prospective study. During this phase, a prototype mHealth app was designed in Adobe XD and a UAT was used in ambulatory IBD patients, with a ≥6 months diagnosis, cared for in a 3rd level hospital during July/2022. The UAT was performed on-line using the Mobile Application Rating Score (MARS), a tool of 30 questions scaled with Likert. It was taken as a reference a Likert (L) 4-5 (very good-excellent). MARS was translated from English to Spanish using the Sperber method. This study was approved by the institutional ethics committee (633 LMiP0Se/22).

Results

The prototype has the following purposes: symptom registry, medication reminder, pending studies, and food diary. Of the 40 people invited for the UAT, 38 accepted and 33 showed ≥75% of the MARS. The sample had a median age of 35 (29-45), 20/33 (60.6%) women, 22/33 (66.7%) ulcerative colitis, and 11/33 (33.3%) Crohn's disease. There was a higher score between questions related to functionality (L4-5 96%), followed by adherence to mHealth app (L4-5 80.3%), content (L4-5 76.5%), and design (L4-5 68.7%). mHealth app specific IBD evaluation had a very good-excellent score in 93.1% of the input. The mHealth app was rated with four and five stars by 20/33 (60.1%) and 5/33 (15.2%), respectively. There was a 1.4% input loss (Figure 1).

Conclusion

The recently developed mHealth app constitutes an intuitive, easy-to-use multifunctional free access tool highly accepted among Spanish speaking patients with IBD.

Disclosure

Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Boston Scientific, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, and mdconsgroup. The other authors declare no conflicts of interest.

Introduction

Information and communications technology (ICTs) include computer applications for dialogical, informative, or social use. ICTs are resources in the management of chronic diseases such as inflammatory bowel disease (IBD).

Aims & Methods

To understand their use by IBD patients in Latin America (LatAm), we aimed to assess the barriers and preferences (B&P) of ICTs in this population. From May to June 2022, 17 centers from 9 Spanish-speaking countries in LaTam were invited to participate in a survey-based-study to assess patients with IBD. A 351 cases sample was calculated. Included patients were >15-year-old, with IBD confirmed by histopathology. Patients diagnosed <6 months, hospitalized, without IBD-specific treatment, with psychiatric or oncological disease, health care providers, and unable to answer the survey were excluded. An ad-hoc, anonymous, and online survey was designed. The use of ICTs was estimated using a Likert scale. Surveys with >25% blank data were excluded; in those with <25%, blank questions were counted as such. A sample of 205 was calculated.

Results

341 cases from 11/17 centers of 6/9 countries were included: Argentina 216, Uruguay 58, Ecuador 33, Chile 16, Peru 12, Paraguay 6. Median age was 37 /28-51) years; 200 (58.7%) females; 240 (70.4%) ulcerative colitis (UC), 90 (26.4%) Crohn’s Disease (CD), and 11 (3.2%) indeterminate colitis (IBDU); 14 (4.1%) rurality; 158 (46.3%) complete secondary education, and 111 (32.6%) higher education. 306 (89.7%) owned a smartphone. WhatsApp (WA) was the most frequently used ICT by 325 (95.3%), followed by Instagram (Ig) 199 (58.4%), email 195 (57.2%), Facebook (Fb) 192 (56.3%), and YouTube (YT) 175 (51.3%). For IBD-specific purposes, the most used were WA 130 (38.1%), Fb 93 (27.3%), email 83 (24.3%), YT 73 (21.4%), and Ig 72 (21.1%). 48% used at least one ICT daily. 61.3% stated that they totally/strongly agreed to use ICTs to seek information on self-care measures, 57% diets, and 54% symptoms. Only 15.8% stated that this information was easily accessible, 45.7% easy to understand, 34.9% of good quality, and 25% were concerned about data privacy. 91.5% stated that they would use an IBD-specific application to obtain updated information on IBD and 88.6% stated a preference for mobile-availability (Figure 1).

Conclusion

IBD patients in LatAm use different ICTs for IBD-specific purposes. ICTs are means to transmit information and maintain communications with and among patients with IBD. However, it is necessary to improve access, accuracy, and understanding of such resources while ensuring patient data privacy. To our knowledge, this is the first study to describe B&P with ICTs use in LatAm IBD patients. NCT04893928.

Disclosure

Carlos Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Boston Scientific, Steris, Medtronic, Motus, Micro-tech, G-Tech Medical Supply, CREO Medical, EndoSound, and mdconsgroup. The other authors declare no conflicts of interest.

Introduction

Inflammatory bowel disease (IBD) management faces significant care gaps, particularly in areas such as diet and mental health support. Digital health applications provide remote support to patients with IBD to improve health, however few digital applications have published evidence of efficacy.

Aims & Methods

The purpose of this randomized controlled trial (RCT) was to identify if use of the LyfeMD digital health platform results in significant changes in health behaviours among patients in remission with Crohn’s Disease (CD) and Ulcerative Colitis (UC). LyfeMD is an integrated digital and human platform designed to improve physical and mental health. Patients over the age of 18 with UC or CD in remission were recruited in Calgary, Alberta. Participants were randomly assigned to the LyfeMD intervention (n=10) or the standard care control (n=10) group. The intervention group was given access to the LyfeMD mobile app for 8 weeks and assigned a health coach. Self-reported validated measures were collected at baseline and week 8 including demographics, leisure-time physical activity (LTPA), stress score (SS), depression and anxiety risk, sleep, screen-time outside of work, and sitting time. Diet intake was collected using 2 consecutive 24-hour recalls (ASA-24) at baseline and week 12. Intake data was used to calculate the healthy eating index (HEI). Independent and paired sample t-tests were used to identify significant differences between and within groups.

Results

Twenty people were recruited for this study (N=10 per group); 65% were female, with a mean age of 45.3 years (standard deviation) [SD] =9.9). Mean body mass index was 28.1kg/m2 (7.0) and 80% of the participants had CD. After 8 weeks the intervention group showed significant improvements in risk of anxiety (mean = -1.9/21 [2.3]) screen time (mean = -7.2/168 hours/week [11.3]), sitting hours (-10.6/168 hours/week, [12.9], and overall well-being (mean = +12.5/100 [21.2]) (p<0.05). At week 12 the intervention group also showed significant improvements in both overall diet quality (mean = +12.2/100 [16.6]) and moderation scores (mean= +5.6/50 [5.0]). Between the groups we see significant differences for both sitting time and for the moderation component of the HEI (p<0.05).

Conclusion

The LyfeMD digital health platform is a safe option for patients with IBD, providing accessible lifestyle therapy thus, reducing current gaps in the healthcare system. Future studies should focus on an increased sample size and targeting remote populations where this program may be even more valuable to healthcare providers and patients.

Disclosure

Lorian Taylor, Puneeta Tandon and Maitreyi Raman are cofounders of LyfeMD. Vidya Rajagopalan at the time of this study worked for the University of Calgary and presently works for LyfeMD.

Introduction

As a chronic disease, patients’ perspectives of the quality of care (QoC) provided are increasingly recognized as an essential aspect of inflammatory bowel disease (IBD) management and an essential standard for units that manage patients with IBD¹.

Aims & Methods

Aims:
- Primary: Translation and validation of the Portuguese version of the IQCARO-QoC decalogue².
- Secondary: identify factors associated with a perception of better QoC.
Methods: A unicentric cross-sectional study was conducted in an IBD unit in a non-tertiary hospital. All consecutively evaluated IBD patients in the outpatient setting between january and december 2023 were included. Demographic and disease characteristics were collected.
The original version of IQCARO-QoC decalogue was translated and adapted into Portuguese (independent forward and back-translation).
Validity was assessed through correlation between IQCARO-QoC and visual analogue scale (VAS). Fiability was assessed through internal consistency, test-retest and intraclass correlation. Test–retest (4-week repeat) was used for measuring reliability.
Factors associated with QoC were analyzed.

Results

A total of 114 patients were included (51% female; mean age: 44±15years), of whom 63% had Crohn’s disease. 69% of patients were receiving biological therapy. Among the patients, 24% were solely in clinical remission and 48% in both clinical and endoscopic remission. 31 patients (27%) perceived their disease to be in remission.
The mean IQCARO score was 9.3±1.9. Construct validity analyses demonstrated moderate-to-strong correlations between the IQCARO-QoC and VAS. The IQCARO-QoC exhibited high internal consistency (Cronbach’s α = 0.703) and intraclass correlation (intraclass correlation coefficient = 0.622).
In univariate analysis, concerning patients' self-assessment of disease activity, those who considered their disease to be in remission reported higher IQCARO scores (p=0.02). Individuals with higher educational levels tended to perceive higher QoC (p=0.037). Disease duration, previous surgeries, hospitalizations, and number of outpatient appointments did not exhibit a statistically significant impact on QoC perception. Regarding quality of life, as assessed by the SIBDQ³ with a mean score of 50.7±12.1, a statistically significant positive correlation was observed between QoC and the SIBDQ (r=0.276, p=0.004).
Multivariate analysis revealed that education significantly influenced the perception of QoC provided (β = -0.284 [-1.490; -0.340], p=0.002).

Conclusion

The Portuguese version of the IQCARO-QoC is a simple, valid, and reliable tool for assessing the QoC perception among patients with IBD in clinical practice. Furthermore, these observational data suggest an association between patients' perspectives of QoC and their evaluations of disease activity and quality of life. In our cohort, education emerged as an independent predictor influencing the perception of QoC received.

References

1 - Fiorino G, et al. Quality of Care Standards in IBD: a ECCO Position Paper. J Crohns Colitis. 2020 Sep 7; 14(8):1037-1048.
2 - Calvet X, Saldaña R, Carpio D, Mínguez M, Vera I, Juliá B, Marín L, Casellas F. Improving Quality of Care in Inflammatory Bowel Disease Through Patients' Eyes: IQCARO Project. Inflamm Bowel Dis. 2020 Apr 11;26(5):782-791.
3 - Roseira J, Sousa HT, Marreiros A, Contente LF, Magro F. Short Inflammatory Bowel Disease Questionnaire: translation and validation to the Portuguese language. Health Qual Life Outcomes. 2021 Feb 18;19(1):59.

Introduction

Therapeutic progress in inflammatory bowel disease (IBD) is limited by the lack of understanding of the pathophysiology and the mechanisms involved in response or lack/loss of response to treatments. IBD patients are treated with anti-inflammatory drugs, including biologics such as anti-tumor necrosis factor (TNF) agents, which have been crucial in achieving steroid-free remission and prevention of long-term complications. However, a significant subgroup of patients becomes refractory to these biologicals due to the development of immunogenicity, characterized by the presence of anti-drug antibodies (ADAs). The antibody production and peripheral tolerance are initiated and maintained within lymphoid organs, such as the peripheral lymph nodes, but the exact role of immune cells in these lymphoid structures and whether they are involved in anti-drug antibody (ADA) formation is unknown.

Aims & Methods

We aimed to unravel the pathophysiology behind the development of anti-drug antibodies. Therefore, we performed ultrasound-guided inguinal lymph node needle biopsies from which we isolated leukocytes along with PBMCs from the same patients. Leukocyte populations were analyzed at single cell level via high dimensional phenotyping through mass cytometry (CyTOF).

Results

Using this unique approach, we have so far results from 4 Crohn’s Disease (CD) patients with ADAs (75% females, 50% active disease) and 4 without ADAs (50% females, 75% active disease). Active disease was defined, as an observation of an elevated CRP (c-reactive protein) (>5 mg/L) and/or calprotectin >250 (mg/kg), including symptoms (Harvey-Bradshaw index score > 4 or disease activity index score-CDAI >150).
The proportion of CD4⁺ TEMRA (terminally differentiated effector memory T-cells), CD4⁺ effector and central memory T-cells were increased in the peripheral lymph nodes of patients that developed immunogenicity. Mature NK cells, classical and non-classical monocytes were also increased. Furthermore, the levels of the alpha-4 integrin expression were higher in the lymph node T-lymphocytes, as well as, in the lymph node naïve and memory B-cell subsets in the patient group with ADAs.

Table: Cytometry and Biochemical Characteristics.

Conclusion

Lymph node T-helper cells, monocytes and NK cells potentially play a role in the development ADAs in IBD patients treated with biologics. Although, there was no significant difference in the proportion of naïve and memory B-cells, our findings concerning the alpha-4 integrin expression levels also indicate that both lymph node T and B-lymphocytes, are possibly characterized by a higher migratory potential during immunogenicity conditions.

References

1. Stein RE, Lee DY, Leonard MB, et al. The association between drug levels, anti-drug antibodies, and therapeutic response during infliximab therapy in pediatric Crohn’s disease. J Crohns Colitis 2014; 8: S434.
2. Bodini G, Savarino V, Dulbecco P, et al. The influence of anti-adalimumab antibodies on adalimumab trough levels, TNF-alpha levels and clinical outcome. J Crohns Colitis 2014; 8: S42
3. Stefan S, Sandborn WJ, Choi J, et al. Anti-drug antibodies separate responses of markers of inflammation (c-reactive protein, fecal calprotectin) in Crohn’s disease patients treated with certolizumab pegol. Inflamm Bowel Dis 2014; 20: S68.
4. Strand V, Balsa A, Al-Saleh J, et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs. 2017;31(4):299-316. doi:10.1007/s40259-017-0231-8.
5. Brun MK, Goll GL, Jørgensen KK, et al. Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial. J Intern Med. 2022;292(3):477-491. doi:10.1111/joim.13495.

Disclosure

The authors state no conflict of interest.

Introduction

Patients with inflammatory bowel disease (IBD) require long-term, intensive care. To optimise future healthcare delivery, identifying patients suitable for remote monitoring is crucial. Patient-reported outcome measures integrated within eHealth systems, such as the 4-item Mobile Health Index (mHI)¹, offer potential for predicting disease activity. This study explores the predictive value of the mHI within the e-health system DEARhealth² at a Dutch university medical centre.

Aims & Methods

This multi-centre prospective cohort study tracked IBD patients within the e-health system. Patients were categorised into high-, intermediate-, and low-risk groups based on current and past biochemical disease activity. High-risk patients had current biochemical disease activity (FCP > 150 µg/g and/or CRP > 5 mg/L), intermediate-risk patients were in remission but experienced a biochemical flare within the last three years, while low-risk patients had been in biochemical remission for at least three years. A personalised care pathway, considering both risk group and medication usage, dictated the frequency of outpatient visits and lab tests. Over a 24-month period, patients are monitored according to standard of care (biochemical disease activity; endoscopic disease activity) and with mHI scores at both pre-defined time points and patient-initiated moments. These preliminary results focus on assessing the predictive value of the mHI, above a validated cut-off value¹, at baseline for predicting a flare within six months. Sensitivity, specificity, and predictive values are calculated alongside simple logistic regression and Kaplan-Meier analyses.

Results

Out of 319 patients (56.7% Crohn’s Disease (CD), median age 43 years, median disease duration 15 years), 89 exhibited biochemical disease activity at baseline and were excluded from the current analysis. Among the 230 patients in remission at baseline, 51 (21.3%) scored above the mHI cut-off point at baseline and 79 (34.3%) experienced a biochemical flare-up within six months of follow-up. The relative risk of experiencing a disease flare in Ulcerative Colitis (UC) patients with a baseline mHI score above the cut-off point was 2.44 (p = 0.04) with sensitivity of 42.1%, specificity of 82.4%, positive predictive value of 40.0%, and negative predictive value of 83.6%. In CD patients, this relative risk was 1.62 (p = 0.39) with sensitivity of 38.5%, specificity of 73.4%, positive predictive value of 14.7%, and a negative predictive value of 90.9%. Logistic regression analysis revealed a significant association between a mHI score above the cut-off point and disease flares in UC patients (OR = 3.394, 95% CI: 1.110-10.330, p = 0.03), whereas in CD patients, such an association was not significant (OR = 1.724, 95% CI: 0.487-5.603, p = 0.37). Similarly, Kaplan-Meier analysis demonstrated a longer flare-free survival in UC patients with a baseline mHI score below the cut-off point (p = 0.03), while no significant difference was observed in CD patients (p = 0.14).

Conclusion

This study indicates that the mHI could be a valuable tool for predicting disease activity, and particularly quiescent disease, in UC patients. However, this predictive capability was not observed in patients with CD. These results underscore the potential utility of mHI in enhancing the management of IBD patients, with implications for personalised care and resource allocation within healthcare systems. Further research should explore repeated mHI measurements in combination with biomarkers like calprotectin for a more comprehensive approach.

References

¹ Van Deen, W. K., van der Meulen-de, A. E., Parekh, N. K., Kane, E., Zand, A., DiNicola, C. A., ... & Hommes, D. W. (2016). Development and validation of an inflammatory bowel diseases monitoring index for use with mobile health technologies. Clinical gastroenterology and hepatology, 14(12), 1742-1750.

² DEARhealth: Software as a medical device using Dynamic & Risk-based care pathways and Smart Decision Support Recommendations. DEARhealth. (n.d.). https://dearhealth.com/hospital/

Disclosure

PWJM reports consulting fees from Abbvie and Takeda, and payment for presentations from Galapagos and Takeda. PWV reports consulting fees from Abbvie, Galapagos, BMS, Janssen, Lilly, and Takeda, and payment for presentations from Galapagos and Takeda. AEvdMdJ received research grants from Nestle, Norgine, Cablon, Galapagos, and ZonMw, including speaker’s fees from, Tramedico, Janssen Pharmaceuticals, Takeda, Galapagos, Vedanta, Ferring, and AbbVie. These are not related to this work. All other authors have no conflicts of interest to declare.
This study has received funding from Galapagos/Alfasigma

Introduction

Information and communication technologies (ICTs) represent a novel approach to chronic disease management. However, their use in Inflammatory Bowel Disease (IBD) is scarce as no specific tools are available. Our aim was to develop a microlearning programme for IBD patients and to evaluate their outcomes with respect to adherence, medication beliefs and perception of the disease.

Aims & Methods

Prospective cohort study in adult IBD patients (18-70 years) who underwent a microlearning programme over 2 months, through 4-minute videos organised into individualised video pathways that were sent via mobile phone using a Telegram bot. All patients received the main pack of 4 videos, consisting of 2 videos with information about their disease (ulcerative colitis or Crohn's disease), 1 video on adherence and 1 video on corticosteroid treatment. We then add a video for each medication used by the patient in the management of their IBD. Before starting the programme and at 6 months, patients completed the BMQ (Beliefs Medicines Questionnaire) and Brief Illness Perception Questionnaire (BIPQ). We checked the medication possession rate (MPR) at these same intervals, considering a MPR ≥80% as adequate adherence.

Results

Between June and October 2022, 1226 videos were sent to 200 IBD patients: 51.5% female (103), Ulcerative colitis 52.5% (105), median age 46.1 (13.2) years (Table 1). The median of videos per patient was 6 (6-7). Attendance to the ADEII programme ranged from 78% to 90%. Baseline non-adherence in this cohort was 29.8% (59 patients), decreasing significantly to 18.1% (36) after the programme (p=0.02). Likewise, in the BMQ scales, we found significant decreases in the median and IQR of the BMQ scores : Medication Abuse: 8 (7-9) vs 8 (6-9) (p=0.001), BMQ-Medication Harm 10 (8 -12) vs 9.5 (7-11) (p=0.002) and BMQ-Treatment Concern 13.5 (11-16) vs 13 (10-16) (p=0.001), with no change in BMQ-Treatment Need. Regarding illness perception, on the post-intervention BIPQ scale there were significant decreases in P8 Negative Emotions 6 (3-8) vs 5 (3-7) (p=0.003) and P5 Identity 6 (4-8) vs 5 (3-7) (p=0.003), as well as a significant increase in P7 Understanding of illness 7 (5-9) vs 8 (7-9) (p=0.003).

Conclusion

The ICT-based ADEII educational programme was widely accepted by patients, demonstrating an improvement in adherence to treatment with a decrease in negative beliefs about medication and negative emotions and representations, improving the understanding of the disease.