Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation

Conditions

Stoma Colostomy, Stoma Ileostomy

Brief summary

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 software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.

R Brady, Diane Sheard, Mandie Alty, Martin Vestergaard, Esben Bo Boisen et al. (8 authors)

British Journal of Nursing2025-01-132 citations

10.12968/bjon.2023.0278

Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial.

Brady RR, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA.

2025-01-01

10.12968/bjon.2025.0278

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

R Brady, Diane Sheard, Mandie Alty, Martin Vestergaard, Esben Bo Boisen et al. (8 authors)

Journal of Clinical Medicine2024-09-247 citations

10.3390/jcm13195673

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.

Ambe PC, Brunckhorst E, Hansen HD, Gotfredsen JL, Vestergaard M, Ajslev TA.

2023-09-011 citations

10.1016/j.mcpdig.2023.06.013

Interventions

DEVICEHeylo

Test of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Have provide written informed consent. 2. Be at least 18 years of age and have full capacity. 3. Have had their stoma for less than 9 months. 4. Have intact skin on the peristomal area (assessed by investigator) 5. Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm) 6. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7) 7. Is willing to refrain from use of paste and protective sheets. 8. Have a smartphone applicable for the HeyloTM app. 9. Have been self-managing stoma appliance for at least 14 days. 10. Are able to follow study procedures for 3 months (assessed by investigator) 11. Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.

Exclusion criteria

1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 2. Is breastfeeding. 3. Is pregnant based on urine pregnancy test. 4. Enrolled in another current research study or have previously participated in this investigation. 5. Has known hypersensitivity towards any of the products used in the investigation. 6. Is using/have a pacemaker. 7. Has a complicated stoma at baseline (dehiscence/prolapse/hernia) 8. Has limited life expectancy or receive palliative care. 9. Has stage 4 cancer. 10. Having more than one stoma synchronously 11. Having ongoing non-healed abdominal wounds 12. Reoperation / stoma reversal planned during the study period.

Design outcomes

Primary

Measure	Time frame	Description
Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks	Baseline (Day 0) and Final Evaluation (Week 12)	Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)?

Secondary

Measure	Time frame	Description
Ostomy Leakage Impact Tool - 'Emotional Impact' Domain	Baseline (Day 0) and Final Evaluation (Week 12)	Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.
Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain	Baseline (Day 0) and Final Evaluation (Week 12)	Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.
Patient Self-management	Baseline (Day 0) and Final Evaluation (Week 12)	Patient Activation Measure (PAM) score The Patient Activation Measurement (PAM) is scored on a scale ranging from 0 to 100. Individuals who score high on this instrument typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so.
Health Related Quality of Life	Baseline (Day 0) and Final Evaluation (Week 12)	The EQ-5D-5L instrument consists of five dimensions with five predetermined levels of response that is used to generate a health state profile, which then can be assigned a summary index score. Translation of health states and index scores are based on the specific value set for United Kingdom. The index scores based on the value set for United Kingdom ranges from -0.285 to 1. Index score of -0.285 is the worst health state. Index score of 1 is the best health state.
EQ-5D-5L Visual Analogue Scale (VAS)	Baseline (Day 0) and Final Evaluation (Week 12)	Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).
Ostomy Leakage Impact Tool - 'Coping and in Control' Domain	Baseline (Day 0) and Final Evaluation (Week 12)	Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life.

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Test Product - New Supporting Ostomy Product and Support Service The arm includes the newly developed ostomy support product together with a support service Heylo: Test of the supporting product (test product) for a 12 weeks period. No measurement will be conducted. All endpoints are captured via surveys send to the subjects every 14 days.	92
Total	92

Baseline characteristics

Characteristic	Test Product - New Supporting Ostomy Product and Support Service	—
Age, Continuous	49.4 years	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United Kingdom	92 participants	—
Sex: Female, Male Female	49 Participants	—
Sex: Female, Male Male	43 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 100
other Total, other adverse events	20 / 100
serious Total, serious adverse events	5 / 100

Outcome results

Primary

Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks

Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)?