An interventional study of Heylo in Stoma Ileostomy and Stoma Colostomy, sponsored by Coloplast A/S. Completed at 10 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Supportive care
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.
Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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)?
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (Day 0) and Final Evaluation (Week 12)
| Milestone | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Started | 100 |
| Baseline (intention to treat population) | 92 |
| Completed | 80 |
| Not completed | 20 |
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)?
| Number of leakages per two weeks | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Baseline | 1.57 (1.19 to 2.08) |
| Final evaluation | 0.93 (0.56 to 1.54) |
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.
| score on a scale | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Baseline | 68.201 (64.677 to 71.726) |
| Final evaluation | 74.815 (71.217 to 78.414) |
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.
| score on a scale | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Baseline | 57.124 (52.375 to 61.873) |
| Final evaluation | 77.136 (72.280 to 81.991) |
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.
| score on a scale | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Baseline | 82.750 (78.447 to 87.054) |
| Final Evaluation | 89.072 (84.726 to 93.418) |
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.
| score on a scale | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Baseline | 62.779 (57.586 to 67.973) |
| Final Evaluation | 77.082 (71.757 to 82.408) |
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.
| score on a scale | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Baseline | 0.713 (0.663 to 0.763) |
| Final evaluation | 0.747 (0.696 to 0.798) |
Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).
| score on a scale | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Baseline | 71.771 (68.089 to 75.453) |
| Final evaluation | 76.454 (72.713 to 80.196) |
Collected over Adverse events were recorded during the study period being 12 weeks ± 2 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Population | 0/100 (0%) | 5/100 (5%) | 20/100 (20%) |
| Event | Safety Population |
|---|---|
| Patient was admitted into the hospital for subarachnoid hemorrhage and encephalitisNervous system disorders | 1/100 |
| Low NeutrophilsBlood and lymphatic system disorders | 1/100 |
| Bleeding StomaGastrointestinal disorders | 1/100 |
| DehydrationMetabolism and nutrition disorders | 1/100 |
| DiarrhoeaGastrointestinal disorders | 1/100 |
| VomitingGastrointestinal disorders | 1/100 |
| Admitted to hospital as a result for producing high output black stoma contentsGastrointestinal disorders | 1/100 |
| Abdominal painGastrointestinal disorders | 1/100 |
| Intestinal BlockageGastrointestinal disorders | 1/100 |
| Intestinal infectionGastrointestinal disorders | 1/100 |
| Event | Safety Population |
|---|---|
| Skin redness and irritationSkin and subcutaneous tissue disorders | 18/100 |
| HeadacheNervous system disorders | 6/100 |
| Age, Continuous(years) | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Mean | 49.4 (18 to 81) |
| Sex: Female, Male(Participants) | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| Female | 49 |
| Male | 43 |
| Race and Ethnicity Not Collected(Participants) | Test Product - New Supporting Ostomy Product and Support Service |
|---|
| Region of Enrollment(participants) | Test Product - New Supporting Ostomy Product and Support Service |
|---|---|
| United Kingdom | 92 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Nov 2021 to primary completion in Aug 2022, 8 months.
Results were first posted in Aug 2024, 1 year 11 months after primary completion.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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