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

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

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.

Study Overview

• Status: Completed
• Conditions: Stoma Ileostomy; Stoma Colostomy
• Intervention / Treatment: Device: Heylo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom
    • Southmead/North Bristol NHS Trust
  • Chelsea, United Kingdom
    • Chelsea & Westminster Hospital
  • Exeter, United Kingdom
    • Devon/Royal Devon and Exeter NHS Foundation Trust
  • Great Yarmouth, United Kingdom
    • Norfolk/James Paget University Hospitals NHS Foundation Trust
  • Leeds, United Kingdom
    • Leeds/Leeds Teaching Hospitals NHS Trust
  • Manchester, United Kingdom
    • Illingworth
  • Middlesbrough, United Kingdom
    • Middlesbrough/South Tees NHS trust, James Cook University Hospital
  • Newcastle, United Kingdom, NE3 3HD
    • Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Peterborough, United Kingdom
    • Petersborough/ North West Anglia NHS Foundation trust, Petersborough City Hospital
  • Preston, United Kingdom
    • Preston/Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Test product - new supporting ostomy product and support service; The arm includes the newly developed supporting ostomy product (leakage notification system Heylo) used together with a support service	Device: Heylo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)?	Baseline (Day 0) and Final Evaluation (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Self-management	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.	Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Emotional Impact' Domain	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.	Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain	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.	Baseline (Day 0) and Final Evaluation (Week 12)
Ostomy Leakage Impact Tool - 'Coping and in Control' Domain	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.	Baseline (Day 0) and Final Evaluation (Week 12)
Health Related Quality of Life	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.	Baseline (Day 0) and Final Evaluation (Week 12)
EQ-5D-5L Visual Analogue Scale (VAS)	Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).	Baseline (Day 0) and Final Evaluation (Week 12)

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Richard Brady, Newcastle-upon-Tyne Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CP340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No