Trial Outcomes & Findings for Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation (NCT NCT05135754)
NCT ID: NCT05135754
Last Updated: 2024-08-21
Results Overview
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)?
COMPLETED
NA
100 participants
Baseline (Day 0) and Final Evaluation (Week 12)
2024-08-21
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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100
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Overall Study
Baseline (Intention to Treat Population)
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92
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Overall Study
COMPLETED
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80
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Overall Study
NOT COMPLETED
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20
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=92 Participants
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.
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Age, Continuous
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49.4 years
n=92 Participants
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Sex: Female, Male
Female
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49 Participants
n=92 Participants
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Sex: Female, Male
Male
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43 Participants
n=92 Participants
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Region of Enrollment
United Kingdom
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92 participants
n=92 Participants
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PRIMARY outcome
Timeframe: 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)?
Outcome measures
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=92 Participants
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.
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|---|---|
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Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks
Baseline
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1.57 Number of leakages per two weeks
Interval 1.19 to 2.08
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Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks
Final evaluation
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0.93 Number of leakages per two weeks
Interval 0.56 to 1.54
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=92 Participants
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.
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|---|---|
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Patient Self-management
Baseline
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68.201 score on a scale
Interval 64.677 to 71.726
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Patient Self-management
Final evaluation
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74.815 score on a scale
Interval 71.217 to 78.414
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=92 Participants
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.
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|---|---|
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Ostomy Leakage Impact Tool - 'Emotional Impact' Domain
Baseline
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57.124 score on a scale
Interval 52.375 to 61.873
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Ostomy Leakage Impact Tool - 'Emotional Impact' Domain
Final evaluation
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77.136 score on a scale
Interval 72.28 to 81.991
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=90 Participants
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.
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Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain
Baseline
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82.750 score on a scale
Interval 78.447 to 87.054
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Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain
Final Evaluation
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89.072 score on a scale
Interval 84.726 to 93.418
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=92 Participants
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.
|
|---|---|
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Ostomy Leakage Impact Tool - 'Coping and in Control' Domain
Baseline
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62.779 score on a scale
Interval 57.586 to 67.973
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Ostomy Leakage Impact Tool - 'Coping and in Control' Domain
Final Evaluation
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77.082 score on a scale
Interval 71.757 to 82.408
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=92 Participants
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.
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Health Related Quality of Life
Baseline
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0.713 score on a scale
Interval 0.663 to 0.763
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Health Related Quality of Life
Final evaluation
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0.747 score on a scale
Interval 0.696 to 0.798
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SECONDARY outcome
Timeframe: Baseline (Day 0) and Final Evaluation (Week 12)Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health).
Outcome measures
| Measure |
Test Product - New Supporting Ostomy Product and Support Service
n=92 Participants
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.
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|---|---|
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EQ-5D-5L Visual Analogue Scale (VAS)
Baseline
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71.771 score on a scale
Interval 68.089 to 75.453
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EQ-5D-5L Visual Analogue Scale (VAS)
Final evaluation
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76.454 score on a scale
Interval 72.713 to 80.196
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Adverse Events
Safety Population
Serious adverse events
| Measure |
Safety Population
n=100 participants at risk
n=100 subjects were recruited for the study. All n=100 subjects were included as the safety population. Eight subjects were omitted from the ITT population, as they had not used the Test Product. Six of the eight subjects were screening failures, a single subject wished to discontinue, and a single subject was lost to follow-up before the first visit (V1; baseline).
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Nervous system disorders
Patient was admitted into the hospital for subarachnoid hemorrhage and encephalitis
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Blood and lymphatic system disorders
Low Neutrophils
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Gastrointestinal disorders
Bleeding Stoma
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Metabolism and nutrition disorders
Dehydration
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Gastrointestinal disorders
Diarrhoea
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Gastrointestinal disorders
Vomiting
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Gastrointestinal disorders
Admitted to hospital as a result for producing high output black stoma contents
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Gastrointestinal disorders
Abdominal pain
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Gastrointestinal disorders
Intestinal Blockage
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Gastrointestinal disorders
Intestinal infection
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1.0%
1/100 • Number of events 1 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Other adverse events
| Measure |
Safety Population
n=100 participants at risk
n=100 subjects were recruited for the study. All n=100 subjects were included as the safety population. Eight subjects were omitted from the ITT population, as they had not used the Test Product. Six of the eight subjects were screening failures, a single subject wished to discontinue, and a single subject was lost to follow-up before the first visit (V1; baseline).
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Skin and subcutaneous tissue disorders
Skin redness and irritation
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18.0%
18/100 • Number of events 20 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Nervous system disorders
Headache
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6.0%
6/100 • Number of events 7 • Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER