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P554 Impact of real world home based remote monitoring on quality of care and quality of life in inflammatory bowel disease patients: one year results of pragmatic randomized trial

Atreja A., Khan S., Otobo E., Rogers J., Ullman T., Grinspan A., Itzkowitz S., Maser E., Cohen B., Colombel J.-F., Sands B.

Icahn School of Medicine at Mount Sinai, Department of Medicine, New York City, United States

Background

Patients with IBD are ideal candidates for home-based remote monitoring care that is centered on enhanced symptom tracking and improved communication with care teams. The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes quality of care [QOC] and quality of life [QOL] as compared to a patient education app.

Methods

Participants were randomized to either interventional (HealthPROMISE) or control (education app). All patients completed intake questionnaires assessing health literacy, disease severity, general health status, and demographic information. Patients in the HealthPROMISE arm were able to update their information and receive disease summary, QOC metrics and a graph trending QOL (SIBDQ) scores over time (https://clinicaltrials.gov/ct2/show/NCT02322307).

Results

320 patients were enrolled in the study at Mount Sinai Medical Center (MSMC) (see Table 1). Baseline assessment showed that fatigue and tension (anxiety) were the two most important drivers of poor quality of life. Patients with College Education reported less symptom burden (29.2 vs 36.8, range 10- 70; p<0.01) and better QOL (0.8 vs 0.7; p<0.01), an effect that remained significant in multivariable models.

In a median follow up of 495 days (±135), the proportion of patients meeting all eligible QOC significantly increased in intervention group versus control group (increase of 38% versus 9%, p<0.01) (Fig. 1). Overall QOL started to improve among HealthPROMISE patients within 5 months and has consistently been above the control arm through a median interval of 495 days (Fig. 2).

Table 1. Baseline characteristics of patients in the control and intervention arm

Control (%)Intervention (%)
Number (N)158 (49.4%)162 (50.6%)
Age40.9±13.839.5±12.8
Male82 (51.9%)81 (50.0%)
Female76 (48.1%)81 (50.0%)
Quality of Life (QOL)31.9±11.930.2±11.3
Inflammatory Markers Normal (Patient Reported)46 (29.1%)49 (30.2%)
Mucosal Biopsy Normal (Patient Reported)26 (16.5%)34 (21.0%)
Quality of Care (Overall percentage of Metrics Met)50%50%

Figure 1. Improvement in percentage of patients meeting eligible quality of care metrics in control (9%) versus Intervention (28%), p<0.01.

Figure 2. Interim analysis showing improvement in symptom burden among intervention cohort (p<0.001).

Conclusion

This is one of the first randomized controlled trials of app-based home monitoring in IBD patients. Fatigue and tension are the top two drivers of poor QOL among IBD patients. We found a significant improvement in QOC and QOL in intervention group. With a move towards value based care, digital medicine technology can play an effective role in tracking and managing patient population in IBD centers. Remote monitoring coordinators can help support proactive care without disrupting physicians' workflow.