CP340 SUN-Study
Research type
Research Study
Full title
CP340 SUN-Study Investigation of patient benefits with a new supporting ostomy product and support service in patients with a newly stoma formation.
IRAS ID
297458
Contact name
Thomas Simonsen
Contact email
Sponsor organisation
Coloplast A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone app.
The aim of the study is to investigate patient benefits associated with the utilization of a new supporting ostomy product, when delivered together with an online support service.
The investigation will be conducted from October 2021 to End June 2022. Enrolling up to 90 subjects in UK. Once enrolled the subjects will be in the study for approximately 12 weeks. The test product will be CE-marked prior to study start.
During the investigation, subjects will be asked to fill in surveys after 4, 6, 8, 10 and 12 weeks of using the test product. During the investigation subjects will also receive calls from the study nurse. Purpose of these calls is to check subjects general wellbeing in the study. Up to 10 investigational sites in UK will be involved in this study.
Summary of Results
1 Summary
Title
Time schedule
ITT population
Investigation of patient benefits with a new supporting ostomy product and support service in patients with a newly stoma formation 22. November 2021 (First subject in)
22. August 2022 (Last subject out) 92 subjects having an ileostomy or colostomyIntroduction
People with intestinal stomas (especially an ileostomy) experience many problems with stoma effluent leakage. Leakage of stomal effluent is one of the key factors leading to reduced quality of life, especially for people experiencing leakage of stoma effluent onto clothes. Besides being socially embarrassing, sometimes distressing and inconvenient for the individual to experience leakage of stomal effluent outside the baseplate (e.g. onto clothes or bed sheets), leakage of effluent onto the skin is also an additional risk factor for the development of peristomal skin complications (PSCs).
The Test Product investigated in the present clinical study consisted of (1) a novel supporting ostomy product, which has an adhesive sensor layer to be placed underneath the baseplate (Brand name: Heylo™) and (2) it was delivered together with a support service (Coloplast Charter Support Service). Heylo™ is a CE-marked adherent medical sensor device. The sensor layer consists of an electronic sensor system, which can detect moisture and leakage of effluent underneath the baseplate. A transmitter attached to the sensor layer, constantly measures the status of the user’s baseplate, and via Bluetooth communication, sends status changes to a bespoke smartphone application (app) and thereby help the user to detect leakage before it progresses outside the baseplate. This may eventually improve the user’s confidence and quality of life. The Test Product is intended for people living with an ileostomy or colostomy having liquid and/or mushy effluent.
Objective
The aim of the study was to investigate patient benefits associated with using the novel supporting ostomy product, when delivered together with a support service.
Primary objective
• To investigate the incidence of stoma effluent leakage outside the baseplate when using Test Product.Secondary objectives
• To evaluate patients’ stoma self-management.
• To evaluate health and leakage-related quality of life.
• To assess patients’ evaluation of the Test Product, including preference, interoperability and ease of use.Endpoints
Primary endpoint:
• Number of times with stoma effluent leakage outside the baseplate (e.g. onto clothes or bed sheets) within the last 2 weeksSecondary endpoints:
• Patient Self-management (Patient Activation Measure (PAM)):
o PAM score (0-100)
• Leakage related Quality of Life (Ostomy Leakage Impact (OLI)):
o Emotional impact score (0-100)
o Usual and social activities score (0-100)
o Coping and Control score (0-100)
• Health-Related Quality of Life (EQ-5D-5L):
o EQ-5D-5L – Index score (UK)
o EQ-5D-5L – VAS scoreMethods
The investigation was a multi-centre, open label, single arm case study that recruited 92 subjects (ITT population) with a recent stoma formation (stoma ≤ 9 months) to trial a novel digital ostomy device for 12 weeks +/- 2 weeks. Subjects were provided a product size appropriate for their stoma.
Subjects were asked to fill in questionnaires at baseline (V1) and after 4 (V2), 6, 8 (V3), 10 and 12 (V4) weeks of Test Product use.
At V2, V3 and V4 a call from the study nurse was made to the subjects. In this call, the study nurse conducted relevant evaluations together with the subject on for example number of GP contacts, nurse contacts and peristomal skin health.
Results
When using the Test Product subjects experienced a significant reduction in episodes of leakage outside the baseplate (P = 0.046). At baseline, subjects on average experienced 1.57 (95% CI [1.19; 2.08]) episodes of leakage outside the baseplate during the preceding 14 days. At the final evaluation, subjects experienced on average 0.93 (95% CI [0.56; 1.54]) episodes of leakage outside the baseplate during the preceding 14 days, corresponding to a 41% reduction in episodes of leakage outside the baseplate.
Patients’ ability to self-manage measured by PAM improved significantly with on average 6.6 points (95% CI [3.45; 9.78]) from 68.2 at baseline to 74.8 at the final evaluation with Test Product (P < 0.001), meaning that subjects became more proactive and engaged in recommended health behaviours. The improvement was higher than the minimal clinically important difference (4 points).
Three instruments were used to assess health-related quality of life and mental well-being at baseline and at the final evaluation. The Ostomy Leakage Impact tool is specific for the assessment of the impact of stoma leakage, whereas WHO-5 and EQ-5D-5L are generic tools to assess mental wellbeing and health-related quality of life, respectively.
• Subjects reported significantly lower impact on stoma-related QoL, with better scores in all three domains of the Ostomy Leakage Impact tool when using the Test Product compared with baseline. The higher scores reflected that the subjects were less impacted by leakage in daily life. In the emotional domain the impact score increased the most with 20.0 points (95% CI [15.0; 25.0], P < 0.001) from baseline to the final evaluation. The usual and social activities domain increased 6.3 points (95% CI [2.7; 9.9], P < 0.001) and the coping and control domain increased 14.3 points (95% CI [8.3; 20.4], P < 0.001) from baseline to the final evaluation. For all three domains the improvements were higher than the minimal clinically important differences.
• Subjects scored significantly higher on the generic WHO-5 well-being index, with the score increasing 8.0 points (95% CI [4.2; 11.8], P < 0.001).
• Additionally, subjects scored significantly higher on the EQ VAS instrument with an improvement of 4.7 points (95% CI [1.6; 7.8], P = 0.004), whereas the increase on the EQ-5D-5L index score was insignificant (Δ0.034; 95% CI [-0.00; 0.07], P = 0.075).
Subjects worried less about leakage when using the Test Product compared with baseline when assessed on a five-point Likert-scale (P < 0.001) and had a higher feeling of security (P < 0.001).The results revealed no safety concerns.
Conclusion
The study showed a significant reduction in leakage episodes outside baseplate onto clothes as well as strong improvements to subjects’ quality of life with a new digital leakage notification system delivered together with a support service. Subjects also showed increased knowledge, skill, and confidence in managing their own health when using the Test Product compared with baseline. Relieving users from leakage outside baseplate and the related worry and embarrassment can lead to improvement in their quality of life.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0196
Date of REC Opinion
30 Sep 2021
REC opinion
Further Information Favourable Opinion