ArticleMayo Clinic proceedings. Digital health2023
Effect of a Novel Digital Leakage Notification System (Heylo) for Ostomy Care on Quality of Life and Burden of Living With an Intestinal Ostomy: The ASSISTER Trial, A Randomized Controlled Cross-Over Trial.
Article in Mayo Clinic proceedings. Digital health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed.
- Effects of digital health interventions on self-care and quality of life in patients with an ostomy: A systematic review and meta-analysis.Asia-Pacific journal of oncology nursing · 2026Review
- Impact of a Digital Leakage Notification System on Healthcare Resource Utilisation and Costs for People with Stomas in the United Kingdom: Analysis of Interim Results from a Prospective Longitudinal Study.Journal of market access & health policy · 2026Article
- Impact of a Digital Leakage Notification System on Leakage, Quality of Life, Healthcare Resource Utilisation, and Work Productivity: Interim Results from a Longitudinal Real-World Study in the UK.Journal of clinical medicine · 2026Article
- Effects of Intestinal Stoma Odor and Pouch Ballooning on Quality of Life and Associated Intervention Strategies.Journal of multidisciplinary healthcare · 2026Review
- Cost-Effectiveness of a Digital Leakage Notification System (Heylo™) for People with Ileostomies or Colostomies in the United Kingdom.PharmacoEconomics · 2025Article
- The Prevalence of Leakage, Peristomal Skin Complications and Impact on Quality of Life in the First Year Following Stoma Surgery.Nursing reports (Pavia, Italy) · 2025Article
- Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial.Journal of clinical medicine · 2024Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: To investigate the effect of a novel digital leakage notification system (Heylo) on quality of life (QoL) and burden of living with an intestinal ostomy. Patients and Methods: A randomized, controlled, open-label, cross-over trial was conducted in Germany with people having intestinal ostomies, who were cared for by 13 ostomy care specialists. Participants with fecal leakage problems were randomized by a centralized system to either Heylo + Standard of Care (SoC) or SoC alone for 8 weeks, whereafter participants crossed over to the opposite treatment for an additional 8 weeks. Primary and secondary end points were: Results: A total of 144 participants were allocated to a treatment sequence after giving informed consent (safety population). Analyses included randomized participants who had been exposed to at least 1 product and with information on at least 1 end point (intention-to-treat population, n=139). Both the Conclusion: Use of Heylo reported positive effects on quality of life and the overall burden of living with an intestinal ostomy.
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Registered trials
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