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

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)