A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients.
Adult
Aftercare
/ methods
Ambulatory Care
/ statistics & numerical data
Feces
/ chemistry
Female
Gastroenterologists
/ statistics & numerical data
Humans
Inflammatory Bowel Diseases
/ therapy
Intention to Treat Analysis
Leukocyte L1 Antigen Complex
/ analysis
Male
Mobile Applications
Patient Acceptance of Health Care
/ statistics & numerical data
Quality of Life
Remission Induction
Smartphone
Surveys and Questionnaires
Symptom Assessment
/ methods
Telemedicine
/ methods
eHealth
mHealth
remote symptom monitoring
Journal
Inflammatory bowel diseases
ISSN: 1536-4844
Titre abrégé: Inflamm Bowel Dis
Pays: England
ID NLM: 9508162
Informations de publication
Date de publication:
18 06 2020
18 06 2020
Historique:
received:
14
06
2019
pubmed:
24
10
2019
medline:
10
9
2021
entrez:
24
10
2019
Statut:
ppublish
Résumé
Providing timely follow-up care for patients with inflammatory bowel disease in remission is important but often difficult because of resource limitations. Using smartphones to communicate symptoms and biomarkers is a potential alternative. We aimed to compare outpatient management using 2 smartphone apps (IBDsmart for symptoms and IBDoc for fecal calprotectin monitoring) vs standard face-to-face care. We hypothesized noninferiority of quality of life and symptoms at 12 months plus a reduction in face-to-face appointments in the smartphone app group. Inflammatory bowel disease outpatients (previously seen more often than annually) were randomized to smartphone app or standard face-to-face care over 12 months. Quality of life and symptoms were measured quarterly for 12 months. Acceptability was measured for gastroenterologists and patients at 12 months. One hundred people (73 Crohn's disease, 49 male, average age 35 years) consented and completed baseline questionnaires (50 in each group). Intention-to-treat and per-protocol analyses revealed noninferiority of quality of life and symptom scores at 12 months. Outpatient appointment numbers were reduced in smartphone app care (P < 0.001). There was no difference in number of surgical outpatient appointments or number of disease-related hospitalizations between groups. Adherence to IBDsmart (50% perfect adherence) was slightly better than adherence to IBDoc (30% perfect adherence). Good acceptability was reported among most gastroenterologists and patients. Remote symptom and fecal calprotectin monitoring is effective and acceptable. It also reduces the need for face-to-face outpatient appointments. Patients with mild-to-moderate disease who are not new diagnoses are ideal for this system. ACTRN12615000342516.
Sections du résumé
BACKGROUND
Providing timely follow-up care for patients with inflammatory bowel disease in remission is important but often difficult because of resource limitations. Using smartphones to communicate symptoms and biomarkers is a potential alternative. We aimed to compare outpatient management using 2 smartphone apps (IBDsmart for symptoms and IBDoc for fecal calprotectin monitoring) vs standard face-to-face care. We hypothesized noninferiority of quality of life and symptoms at 12 months plus a reduction in face-to-face appointments in the smartphone app group.
METHODS
Inflammatory bowel disease outpatients (previously seen more often than annually) were randomized to smartphone app or standard face-to-face care over 12 months. Quality of life and symptoms were measured quarterly for 12 months. Acceptability was measured for gastroenterologists and patients at 12 months.
RESULTS
One hundred people (73 Crohn's disease, 49 male, average age 35 years) consented and completed baseline questionnaires (50 in each group). Intention-to-treat and per-protocol analyses revealed noninferiority of quality of life and symptom scores at 12 months. Outpatient appointment numbers were reduced in smartphone app care (P < 0.001). There was no difference in number of surgical outpatient appointments or number of disease-related hospitalizations between groups. Adherence to IBDsmart (50% perfect adherence) was slightly better than adherence to IBDoc (30% perfect adherence). Good acceptability was reported among most gastroenterologists and patients.
CONCLUSIONS
Remote symptom and fecal calprotectin monitoring is effective and acceptable. It also reduces the need for face-to-face outpatient appointments. Patients with mild-to-moderate disease who are not new diagnoses are ideal for this system.
CLINICAL TRIAL REGISTRATION NUMBER
ACTRN12615000342516.
Identifiants
pubmed: 31644793
pii: 5603780
doi: 10.1093/ibd/izz252
doi:
Substances chimiques
Leukocyte L1 Antigen Complex
0
Banques de données
ANZCTR
['ACTRN12615000342516']
Types de publication
Equivalence Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1098-1109Informations de copyright
© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.