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

Abstract 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.

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N09 Pain management in inflammatory bowel disease: feasibility of an online therapist-supported CBT-self-management intervention

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.993 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S661-S661

Author(s):

L Sweeney ◽

R Moss-Morris ◽

W Czuber-Dochan ◽

C Norton

Keyword(s):

Quality Of Life ◽

Inflammatory Bowel Disease ◽

Chronic Pain ◽

Disease Activity ◽

Bowel Disease ◽

Brief Pain Inventory ◽

Pain Interference ◽

Face To Face ◽

Inflammatory Bowel

Abstract Background Chronic pain is a poorly managed symptom of inflammatory bowel disease (IBD). Cognitive behavioural therapy (CBT) has an evidence-base in functional gastrointestinal conditions and chronic pain. We aimed to test the feasibility and acceptability of a 9-week online facilitator-supported CBT intervention, tailored for people with chronic IBD-related pain. Methods A single arm pre-post design with nested qualitative interviews was used with 20 individuals with IBD and chronic pain. Participants were recruited online through an IBD charity and had consented to research in a previous survey or responded to an online charity advert. Individuals who met the inclusion criteria e.g. reported a pain-interference score of ≥4/10 (Brief Pain Inventory) and had no indicators of acute causes of pain, were invited to take part. Faecal calprotectin was collected. Outcomes included recruitment and retention rates, pain interference and severity (Brief Pain Inventory), quality of life, psychosocial measures and self-reported disease activity (IBD-Control). Follow-up face to face or telephone interviews were conducted following the intervention to obtain feedback on sessions and tasks, facilitator support and areas for improvement. Results Of 145 survey respondents contacted, 55 (37.9%) responded. Two additional individuals were recruited from the study advertisement. 20/57 (35.1%) met screening and eligibility criteria. Twenty consented to the study and 60% of those returning a stool sample were in clinical remission (<250ug/g). One individual withdrew after Session 1, 17 (85%) engaged with intervention sessions and 11 (55%) completed at least 5/9 sessions. 16 (80%) of recruited participants completed the post-intervention questionnaire at week 9. Mean score for overall acceptability was 43.4 (0–70). No changes were observed for pain outcomes, but quality of life and pain self-efficacy increased following the intervention. Self-reported disease activity, depression, anxiety, pain catastrophising and avoidance resting behaviour decreased. Qualitative feedback demonstrated the value of particular elements of the intervention, such as thought monitoring and facilitator support. Some participants felt content was oversimplified and that further information was needed on practical management strategies, including diet. Conclusion Online CBT for chronic IBD-related pain appears feasible and acceptable. The results demonstrate positive effects for improving quality of life and reducing psychological distress, however online and face to face recruitment methods are recommended. To establish efficacy for reducing pain and improving quality of life, larger randomised controlled trials are required.

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An Autoimmune Protocol Diet Improves Patient-Reported Quality of Life in Inflammatory Bowel Disease

Crohn's & Colitis 360 ◽

10.1093/crocol/otz019 ◽

2019 ◽

Vol 1 (3) ◽

Cited By ~ 2

Author(s):

Anita Chandrasekaran ◽

Shauna Groven ◽

James D Lewis ◽

Susan S Levy ◽

Caroline Diamant ◽

...

Keyword(s):

Quality Of Life ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Dietary Intervention ◽

Maintenance Phase ◽

Fecal Calprotectin ◽

Dietary Modification ◽

Patient Reported ◽

Inflammatory Bowel

Abstract Background Prior studies suggest dietary modification may improve clinical response or remission rates in patients with inflammatory bowel disease (IBD). Our aim was to examine whether an autoimmune protocol diet improves quality of life in patients with active Crohn disease (CD) and ulcerative colitis (UC). Methods We conducted an uncontrolled clinical trial of the autoimmune protocol diet in adult patients with active IBD (Harvey–Bradshaw Index ≥ 5 for CD or partial Mayo score ≥ 3 for UC, and erosions/ulcers on endoscopy and/or elevated fecal calprotectin). The dietary intervention consisted of a 6-week elimination phase, followed by a 5-week maintenance phase. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was completed at baseline, and weeks 3, 6, 9, and 11. Results The final cohort included 6 UC and 9 CD participants. Mean SIBDQ score improved significantly from baseline (46.5) to weeks 3 (54.0, P = 0.02), 6 (53.3, P = 0.02), 9 (62.0, P = 0.03), and 11 (60.5, P = 0.05). Among participants completing all 5 surveys, mean SIBDQ increased from 46.5 to 61.5 by week 11 (P = 0.03). By week 3, participants experienced significant improvements in bowel movement frequency (36%, P = 0.04), stress (28%, P = 0.01), and ability to perform leisure/sport activities (29%, P = 0.02). Effects were not significantly different between CD and UC participants. Conclusions Dietary modification can improve quality of life as early as week 3 in patients with active IBD. Larger randomized controlled trials are needed to examine dietary interventions in IBD.

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