An operation that results in the creation of a stoma is a life-changing intervention that may negatively impact patients' physical and psychosocial wellbeing (Richbourg et al, 2007; Pearson et al, 2020; Jeppesen et al, 2022). Living with a stoma necessitates use of pouching systems for the collection of stomal efluent. Although these systems have gradually evolved since their inception, many people living with a stoma continue to struggle with leakages that progress beyond the baseplate, soiling clothes or bed sheets (Martins et al, 2022).
Experiencing leakage is inconvenient and emotionally distressing, and more than 90% of people with a stoma worry about it (Claessens et al, 2015; Jeppesen et al, 2022). Leakage of stomal efluent is associated with significant reductions in quality of life (QoL), with negative effects on people's emotional wellbeing and individual willingness to participate in social activities (Jeppesen et al, 2022). Indeed, the mental burden of leakage has been reported to last up to 1 year after a single incident (Jeppesen et al, 2022).
Coloplast recently undertook three prospective clinical trials to assess a new supporting product for stoma care that involves a novel digital leakage notification system called Heylo™ (Ambe et al, 2023; Brady et al, 2023; Brady et al, 2024). Heylo is intended to help those with intestinal stomas to gain better control of their stoma care by alerting them when efluent is seeping underneath the baseplate (Brady et al, 2023). The system consists of a sensor layer applied under the baseplate, a bluetooth transmitter and a smartphone app, and includes a transmitter charger (Brady et al, 2023). The use of this system has been shown to reduce the number of leakages progressing outside the baseplate and has been reported as leading to improvements in users' QoL (Ambe et al, 2023; Brady et al, 2023; Brady et al, 2024). A full technical description of the Heylo product has previously been published (Brady et al, 2023).
For the clinical trial conducted in the UK, Heylo was delivered together with a telemedicine-based support service. The previous article (Brady et al, 2024) reported on the primary and secondary endpoints of this trial. Multiple exploratory endpoints were also collected as part of this clinical trial. In the present article, the authors report on the feedback provided on different exploratory endpoints concerning the effect of Heylo on patients' worry about leakage, stoma management routines and reported system usability.
Methods
Study design and patients
Study design, description of the test product (Heylo solution and telemedicine-based support service), inclusion/exclusion criteria, selection of study patients, sample-size calculation and adverse events have been described previously in full (Brady et al, 2024).
The study was an interventional, single-arm, open-label, multicentre investigation enrolling patients to use the test product (Heylo delivered together with a telemedicine-based support service) for 12±2 weeks. A private clinical research organisation (CRO) and nine NHS hospital sites across the UK recruited patients. The latter recruited patients from chart/patient list reviews of those who had recently had surgery independently of the sponsor. The CRO recruited participants consecutively from a list of patients (provided by Coloplast), who were registered on the Coloplast Charter database who had had stoma surgery within the preceding 9 months. (The Coloplast Charter offers support on products and routines and helps people with a stoma with product ordering and delivery.)
A list of all patients who met the inclusion criteria was submitted to the CRO for further screening. Patient enrolment by the CRO was independent of the sponsor. The UK hospital sites were identified through open application and approached with assistance from the National Institute for Health and Care Research's site identification processes.
The sites recruited patients who were assessed as being able to follow study procedures for 3 months. The inclusion criteria identified patients who:
Patients were excluded from enrolment in the study for the following reasons, namely if they:
Patients were invited for an information and inclusion visit (V0) and had an opportunity to consider the implications of the study prior to signing consent forms and formally entering the study.
Patients filled in questionnaires at baseline (V1) and after 4 (V2), 6, 8 (V3), 10 and 12 (V4) weeks' use of the test product. Study nurses conducted evaluations together with each patient at V1, V2, V3 and V4. Given the number of endpoints recorded in this study, some exploratory endpoints were assessed only at baseline, at week 6 and at week 10 (see specific endpoints below).
Demographics and endpoints
Demographics, including sex, stoma type, time with stoma, reason for stoma surgery etc, as well as attitudes towards new technologies and phone type used were recorded at baseline (V1).
This article discusses outcomes most relevant to both users and stoma care study nurses involved in the trial. This includes a focus on specific explorative endpoints from the patient questionnaire and all explorative endpoints from the study nurse questionnaire.
To provide feedback on the novel digital leakage notification system, patients were asked to evaluate the following items:
At termination of the study (V4) patients were asked to evaluate the following aspects of the system (for the exact phrasing of the trial questions, see Box 1):
Evaluation of the test product/system by patients
Questions posed at termination of the study (V4)
NB The questions were answered from a set of pre-defined options
Patients selected their responses to the questions from a set of predefined options, which are presented in the figures.
In addition, patients evaluated the test product by using the system usability scale: this consists of a 10-item questionnaire, which explores ease of use, system complexity and confidence in using the system. Each question is answered on a five-point scale, ranging from ‘strongly agree’ to ‘strongly disagree’, which subsequently can be converted into a numerical scale. The scale ranges from 0 to 100, where higher scores mean better usability (Brooke, 1996).
Study nurses at the different investigation sites were asked to evaluate the implications of the test product for each patient after they had completed the trial, by responding to the following questions:
Nurses were able to select their responses to the questions from a predefined set of options, which are presented in the figures.
Statistics
The safety population included all participants who had provided informed consent. To be part of the intention to treat (ITT) population, in addition to providing informed consent, they had to have been exposed to the test product and provided information on at least one endpoint.
Worry about leakage and feeling of security were analysed using proportional odds ratio models, with week as a fixed effect, and subject as a random effect.
The numbers of baseplate changes due to worry about leakage from week 12 (V4) (or last visit after at least 4 weeks use of the test product ifV4 data were missing) and the baseline data (V1) were compared by using a linear mixed model, with week as a fixed effect, and the subject as a random effect.
Questions answered on two-point Likert scales and questions answered on five-point Likert scales (subsequently the answers were grouped in two) were analysed by use of an exact test in the binomial distribution. The purpose of the test was to evaluate whether the group that had assessed the test product positively was significantly larger than 50%. Thus, the null hypothesis is that the two categories occur with equal frequency when applying a 2-sided significance level of 5% (H0: π=0.5; α=0.05). If the lower 95% confidence interval limit was >50%, this meant that the test product had been assessed positively by a majority of users.
Statistical analyses were performed using SASv9.4 (SAS Institute Inc., Cary, NC) after data entry and data management using a validated data management system (Smart-Trial version 2021.4).
Ethical considerations
The study was carried out in accordance with the Declaration of Helsinki and was approved byWest Midlands–South Birmingham Research Ethics Committee (IRAS Project-ID: 297458). It was registered on ClinicalTrials.gov (NCT05135754). All patients were fully informed about the investigation, verbally and in writing, and all gave written informed consent in order to take part. Participation was voluntary and patients could withdraw at any time. The study was conducted between November 2021 and August 2022.
Findings
Demographics and attitudes to technology
A total of 100 patients with recent stoma formation (≤9 months since stoma surgery) were enrolled in the study from 10 sites across the UK (safety population). Eight patients were omitted from the ITT population due to being screen failures or dropping out beforeV1; thus they had either not been exposed to the test product or had not provided information on at least one endpoint. Furthermore, 12 patients did not complete the study as planned: the reasons were adverse events (n=2), lack of effectiveness (n=2), the wish to discontinue (n=4), device deficiency (n=1), lost to follow-up (n=2), and other reason (n=1) (Brady et al, 2024).
Data from the ITT population (n=92) were included in statistical analyses comparing worry about leakage, feeling of security and baseplate changes due to worry about leakage. Only patients completing the study as planned (n=80) provided performance evaluations of the test product.
Patient demographics have previously been reported in detail within the previous report from the trial (Brady et al, 2024). In summary, the mean age of patients was 49.4 years (range 18–81 years; SD=14.7); 53% were female; 80% had an ileostomy and 20% had a colostomy. Patients installed the bespoke Heylo application on their personal smartphones (40% had an Android smartphone and 60% an iOS smartphone).
At baseline (V1) patients were asked about their attitudes to new technology, with almost half reporting a positive view:
A few patients were technology averse:
| Attitude to new technology | ITT population n=92 (%) |
|---|---|
| I am sceptical of new technology | 3 (3%) |
| I am one of the last to use a new technology | 7 (8%) |
| I prefer to wait until the price drops | 13 (14%) |
| I prefer other people to have proven it out [sic] | 26 (28%) |
| I tend to buy/use it before most other people [sic] | 33 (36%) |
| I love new technology | 10 (11%) |
ITT=intention-to-treat population
Worry about leakage and feeling of security
At baseline (Figure 1), 15% of patients worried to a very high degree about leakage, 24% worried to a high degree and 35% worried to some degree. Patients worried significantly less about leakage after 10 weeks of using the test product. At the final evaluation, only 3% of patients worried about leakage to a very high degree, 11% to a high degree and 28% to some degree (P<0.001) (Figure 1a).
At baseline, 12% of the patients stated that their feeling of security was very good, 30% that it was good and 34% that it was acceptable. Patients had a significantly better feeling of security after 10 weeks with the test product. At the final evaluation, 29% of the patients stated that their feeling of security was very good, 34% stated it was good and 28% stated that it was acceptable (P<0.001) (Figure 1b).
Unplanned baseplate changes due to leakage worry
At baseline, patients estimated that they had changed the baseplate 2.47 times (least squares (LS) mean; 95% CI [2.04; 2.91]) in the preceding 2 weeks due to worry about leakage rather than due to actual leakage. When using the test product, the number of baseplate changes due to worry about leakage was halved to 1.24 (LS mean; 95% CI [0.78; 1.70]) in the preceding 2 weeks up to the final evaluation (P<0.001).
Patient evaluation of system usability
Usability of the test product was evaluated at termination of the study using the system usability scale, with the average score being 80.5 (SD 18.7). For example, 71% of patients strongly agreed that the system was easy to use and 76% strongly disagreed that technical support would be necessary in order to use the system.
Patient evaluation of technical assurance
At the final evaluation (Figure 2), patients provided feedback on technical assurance and system stability. The proportion of patients who found the app notifications reliable and trustworthy to some degree, a high degree or a very high degree was 84% (95% CI [74%; 91%]; P<0.0001) (Figure 2a). The proportion of patients who perceived that the notifications came appropriately timed to react to a leakage to a high or a very high degree was 66% (95% CI [55%; 76%]; P=0.0049) (Figure 2b). The proportion of patients who found the system to be stable or very stable in everyday use was 69% (95% CI [57%; 79%]; P=0.0011) (Figure 2c). Although none of the patients evaluated the system as very unstable, 11% described it as unstable.
The percentages cited above are based on sums of raw numbers as highlighted in the tabulation in Figure 2.
Patient evaluations of self-management and self-confidence
Patients evaluated the implications of using the test product on their stoma self-management. The proportion of patients who reported that it made it easier to know when to change their baseplate to a higher or much higher degree was 64% (95% CI [52%; 74%]; P=0.0183) (Figure 3a). Fifty-nine percent (95% CI [47%; 70%]; P=0.1456]) evaluated their confidence at night as higher or much higher when using the test product compared with using their usual baseplate only (Figure 3b). Most patients (88%) (95% CI [78%; 94%]), P<0.0001) reported that the test product gave them peace of mind to some, a high or a very high degree (Figure 3c).
Evaluation of test product by study nurses
Following completion of each patient's participation in the trial, the study nurses evaluated ease of training and ability to onboard patients to the test product. They also recorded perceived implications of the test product on patient stoma self-management.
Study nurses perceived that it was easy or very easy to onboard most patients onto the test product (78%; 95% CI [67%; 87%]; P<0.0001) (Figure 4a), and reported that it was easy or very easy to train most patients to use the test product (82%; 95% CI [72%; 90%]; P<0.0001) (Figure 4b).
Study nurses also evaluated that the test product provided support to a majority of patients in managing their stoma to some, a high or a very high degree (84%; 95% CI [74%; 91%]; P<0.0001) (Figure 4c), and that it gave most patients better stoma management routines to some, high and very high degree (82%; 95% CI [72%; 90%]; P<0.0001) (Figure 4d).
The percentages cited above are based on sums of raw numbers as highlighted in the tabulation in Figure 4.
Contact with support service
A total of n=108 calls from the support service to the patients was made, with the reason for the call being recorded in n=94 of cases. Table 2 shows that, in 58% of cases, the main reason for the call related to leakage of stomal efluent, in 13% of cases it was related to questions about the test product and the app, and in 6% of calls the reason related to wet mount notifications (the system detects potential application of the baseplate onto wet skin and alerts the user). During the calls other topics were also discussed, with the most commonly recorded conversations relating to good product fit, leakage issues and use of accessories (data not shown).
| Total during study N=94 | |
|---|---|
| First leakage outside baseplate | 9 (10%) |
| Issues with leakage outside baseplate | 14 (15%) |
| General leakage issues | 31 (33%) |
| Other | 21 (22%) |
| Questions related to test product (charger, transmitter, sensor layer) | 7 (7%) |
| Questions related to test product app | 6 (6%) |
| Wet mount notification(s) (the system detects potential application of the baseplate onto wet skin) | 6 (6%) |
At the final evaluation, 82% (95% CI [71%; 90%]) of the patients who had been in contact with the support service stated that the conversation(s) had been helpful (options: much or very much), with only 7% of participants reporting that they had not found the conversation(s) helpful (options: little or very little).
Preference
At the final evaluation, 73% of patients stated that they preferred the test product compared with their usual pouching system (95% CI [61%; 82%], P<0.0001), and the remainder reported that they preferred their current appliance set-up without the test product. A small number of patients (n=2) discontinued the study, reporting a lack of effectiveness of the test product. It is therefore reasonable to make the assumption that these patients did not have a preference for the test product. As such, when assuming a worst-case scenario, even if all drop-outs (n=12) were assumed to have preferred to use their usual pouching system without the test product, the majority of patients still preferred to use the test product (63%, 95% CI [52%; 73%], P=0.016).
Likewise, the study nurses stated that the test product would be a suitable and recommended addition to most patients' appliance set-up (to 81% of the patients, 95% CI [70%; 89%], P<0.0001). However, in the case of 28% of patients, the study nurses stated that their advice would depend on the health status of each individual. Nineteen percent of the study nurses reported that they would recommend that the study patients continue with their standard care and management.
Discussion
The majority of people living with a stoma struggle with leakage incidents and the resultant mental burden of worrying about this occurring (Claessens et al, 2015; Jeppesen et al, 2022; de Fries Jensen et al, 2023). New interventions in stoma care that improve leakage prevention can lead to improvements in QoL (Erwin-Toth et al, 2012; Walker et al, 2016; del Teso et al, 2022). Three recent clinical trials assessing the same novel digital leakage notification system found that its usage significantly reduced the number of leakage incidents progressing outside the baseplate and concomitantly led to significant improvements in QoL (Ambe et al, 2023; Brady et al, 2023; Brady et al, 2024).
The test product is an innovative digital device developed for stoma care and has multiple components, ie a wearable sensor layer, a transmitter and a mobile application. The study population spanned different age groups (between 18 and 81 years), with patients having different attitudes towards new technology. However, despite this, the usability of the system was rated positively, gaining an average system usability scale score of 80.5, which is interpreted as being good to excellent (Bangor et al, 2009; Brooke, 2013). The system usability scale score for the test product is similar to system usability scale scores previously assessed for commonly used devices, such as iPhones and thermometers (Kortum et al, 2013; Kortum et al, 2015), implying that the interplay between multiple components of the test product was not perceived to be overly complex by the study patients. Not only did the patients rate the system usability to be high, but the study nurses also perceived that it was easy to onboard and train patients in using the system.
Ketelaers et al (2023) recently developed and assessed the usability of a new interactive mobile application providing information on stoma-related topics to support stoma patients pre-operatively and postoperatively, with the intention to improve self-management and reduce healthcare consumption. The system was rated positively by users, who gave it scores in the mid-seventies range using the system usability scale, and patients held generally positive views on the information it provided (Ketelaers et al, 2023). Together with the findings of this trial, this would suggest that people living with a stoma welcome novel digital solutions that can improve their self-management.
When using the test product patients worried less about leakage and had a higher feeling of security compared with when they used their regular pouching system set-up. When using the test product, two thirds of the patients found it easier to recognise when their baseplate needed changing. Additionally, patients estimated that they changed baseplates less frequently due to having less worry about leakage. Episodes of stoma efluent leakage progressing outside the baseplate are inconvenient and emotionally distressing (Jeppesen et al, 2022). A study by de Fries Jensen et al (2023) found that, to mitigate the risk of future leakage incidents, some patients increased the frequency with which they changed their pouching systems, increased their use of supporting products, and had more frequent consultations with health professionals, thereby increasing the economic burden on the healthcare system. In addition, Jeppesen et al (2022) found an association between level of worry about leakage and the use of supporting products: the more people worried about leakage, the more supporting products they used.
Relieving users of the mental burden associated with worrying about leakage may potentially reduce inappropriate use of stoma-care products. Furthermore, use of the digital leakage notification system may also help resolve leakage-related complications and may potentially reduce the related need for consultations with health professionals. The impact on healthcare utilisation should be investigated over a longer time horizon and in a real-world setting.
Stoma care nurses seek to empower patients to self-manage their stoma care (Davenport 2014; Krouse et al, 2016). Supported self-management is also part of the NHS Long Term Plan (NHS England, 2019), with the aim of empowering people to better manage their ongoing physical and mental health conditions. The test product was assessed by most study nurses to support patients in better stoma self-management, as well as leading to better stoma care routines.
Consultations with stoma care nurses have been associated with fewer stoma-related problems, including fewer leakage incidents, improvements of peristomal skin health and an improved QoL (Karadağ et al, 2003; Hendren et al, 2015; Harputlu et al, 2018). The test product in the present study was delivered together with a telemedicine-supported leakage service that may aid struggling users to mitigate the risk of future leakage incidents. Besides the direct patient benefits highlighted, the test product is considered to be complementary to general stoma nurse counselling, to promote patients' stoma self-management and enable good stoma-care routines. Use of the product might permit stoma care nurses, who constitute a valuable but limited resource in modern health care, to focus resources on patients who continue to struggle.
Limitations
Interpretation of the study results should consider the limitations of the study design. The trial was a non-blinded, single-arm study, which might have influenced the subjective evaluations of the test product. Improvements could reflect the effect of the test product, a study effect, due to natural improvements with time since surgery or a combination of all three factors. The previous article (Brady et al, 2024) on this clinical study's findings reported that QoL metrics and the number of leakage incidents were similar for individuals across different time points from the time of surgery within the first year.
One inclusion criterion for taking part in the study was that patients should have had their stoma surgery within 9 months prior to enrolment and therefore be new to managing their stoma. This means that these study results may not necessarily be generalisable to experienced users who have been living with their stoma for longer. The test product has, however been assessed in two other clinical studies that reported improvements in leakage prevention and QoL metrics, with both studies including experienced patients (Ambe et al, 2023; Brady et al, 2023).
Conclusion
The findings of this study show that use of a novel digital leakage notification system improved patients' stoma self-management and resulted in better stoma-care routines. Use of the system improved leakage control and enabled individuals to take proactive measures to avoid leakage progressing outside the baseplate, thus alleviating the mental burden of worrying about leakage.
Use of the test product may potentially ensure more efficient use of stoma care products, since patients using the test product estimated that they changed their baseplate less frequently due to less worry about leakage. Further research should be conducted to quantify the impact of the test product in terms of health economic benefits for the healthcare system.