Comparing the efficacy of a web-assisted calprotectin-based treatment algorithm (IBD-live) with usual practices in teenagers with inflammatory bowel disease: study protocol for a randomized controlled trial

Abstract

BackgroundTo prevent clinical relapse in teenagers with inflammatory bowel disease (IBD) there is a need to monitor disease activity continuously. Timely optimisation of medical treatment may nip a preclinical relapse in the bud and change the natural course of IBD. Traditionally, disease monitoring is done during scheduled visits, but this is when most teenagers report full control. IBD care could be more efficient if patients were seen at times of clinical need. This study aims to examine the effectiveness of a web-assisted calprotectin-based treatment algorithm (IBD-live) compared with usual practices in teenagers with IBD.Methods/designA randomized trial of web-based disease monitoring versus usual care is conducted at 10 Dutch IBD care centers. We plan to recruit 180 patients between 10- and 19-years old with quiescent IBD at baseline. Teenagers assigned to IBD-live will use the flarometer -an automatic cumulation of disease activity and fecal calprotectin measurements- to estimate probability of relapse. In case the flarometer indicates high risk the patient requires treatment intensification in accordance with national guidelines; low risk means that maintenance therapy is unchanged; and intermediate risk requires optimisation of drug adherence. Patients assigned to usual practice get the best accepted medical care with regular health checks. Primary outcome is the frequency of relapse at 52 weeks of follow-up. The diagnosis of relapse is based on a clinical activity index score >10 points necessitating remission induction therapy. Secondary outcomes include quality of life and cost-effectiveness.DiscussionWeb-assisted monitoring of disease activity with rapid access for those with acute relapse may allow teenagers to develop skills that are required of adult patients (including communication and self-determination). Similar monitoring systems have been introduced for teenagers with asthma and diabetes, with a positive effect on disease control, but the intervention has not been evaluated in teenagers with IBD. A randomized trial in adult patients with ulcerative colitis showed that a web-assisted treatment algorithm is feasible, safe and cost-effective. Results of the current trial are expected to have important implications for teenagers with IBD that incurs substantial health burdens and economic costs.Trial registrationDutch Trial Register identifier: NTR3759 (registered 29 December 2012)

Agreement Between Home-Based Measurement of Stool Calprotectin and ELISA Results for Monitoring Inflammatory Bowel Disease Activity

“…5 Simultaneously, the number of telemonitoring initiatives for IBD care is rising. [16][17][18][19] Calprotectin home monitoring with a smartphone fits perfectly in the current spirit of the times and is another important step toward patient-centered care. 20 Whether FC home testing is cost effective should be evaluated in future studies.…”

Clinical Utility of Fecal Calprotectin Monitoring in Asymptomatic Patients with Inflammatory Bowel Disease

“…This “traffic light” is currently being evaluated in a prospective multicenter telemonitoring program. 31 Future studies are needed to determine whether pre-emptive treatment intensification based on elevated FC levels will lead to long-term better patient outcomes, including reduction of hospitalizations, disability-associated costs and loss of productivity. The first prospective trials with mesalamine dose intensification 26,32,33 and infliximab dose interval adjustment 34 have already been performed with promising results.…”

Design considerations for an eHealth decision support tool in inflammatory bowel disease self‐management

“…4,[31][32][33][34] However, decision support tools in IBD are now feasible as current eHealth technologies can provide the necessary components, including functionalities that allow recording of PRO and clinical biomarkers, validated disease severity indices on which algorithms can be based and a means of automatically delivering treatment suggestions in real time. [18][19][20][21][22] Validated disease activity indices, such as the Crohn Disease Activity Index (CDAI) and the Simple Clinical Colitis Activity Index (SSCAI), can be reliably completed by patients using eHealth tools to measure disease activity. [35][36][37] Moreover, home-based measurement of faecal calprotectin is feasible and has been shown to agree with hospital-based enzyme-linked immunosorbent assays (ELISA).…”

“…While their application has traditionally been limited to the clinical decision‐making of medical professionals and hospitals, the incorporation of decision support, such as eHealth tools, to aid self‐management in patients with chronic diseases is increasing . Within the IBD community, there is growing interest in the development and implementation of decision support tools, where electronic devices, such as mobile phones and computers, are used to analyse patient symptom data with predetermined algorithms to generate real‐time management plans . eHealth has the potential to augment current models of care and reduce healthcare utilisation by alleviating pressure on overburdened outpatient clinics and hospital emergency departments.…”

“…13 Within the IBD community, there is growing interest in the development and implementation of decision support tools, where electronic devices, such as mobile phones and computers, are used to analyse patient symptom data with predetermined algorithms to generate real-time management plans. [18][19][20][21][22] eHealth has the potential to augment current models of care and reduce healthcare utilisation by alleviating pressure on overburdened outpatient clinics and hospital emergency departments. Although the field of eHealth is rapidly growing in the IBD setting, new eHealth tools should be developed with a level of scientific rigour comparable to conventional medicine, which requires multiple phases, including planning, implementation, evaluation and analysis.…”