Colostomy Stoma, Nurse's Role, Quality of Life, Stoma Ileostomy, Stoma Site Leakage
Conditions
Brief summary
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.
Detailed description
The primary objective is to evaluate the usability of the Body Assessment Tool for the nurse. The secondary objectives are to explore if the use of Body Assessment Tool has an impact on the leakage associated Quality of Life and leakage incidences for individuals living with ostomies. Forty to fifty ostomates will be enrolled from each Nordic country (i.e. Denmark, Sweden, Norway and Finland). The users will be recruited from 5-10 clinics in each country. The evaluation will include 1 visit at the clinic and at least 1 phone call visit to the user (end-of study phone visit). The usability of the Body Assessment Tool will be evaluated by the nurses. The user's leakage and QoL will be evaluated by the end-users.
Interventions
OTHERBody Assessment Tool
Assessment tool to evaluate stoma to find proper ostomy products
OTHERClinical usability evaluation of the Body Assessment Tool
The stoma care nurses evaluated the clinical usability of the Body Assessment Tool, which included answering the following questions: Does the tool offer value in clinical practice? Does it provide a good starting point when choosing ostomy product(s)? Does it help raise the quality of care? Participants provided their responses on a 6 point-scale (1-6), where 1 indicated the lowest satisfaction and 6 the greatest satisfaction with the tool.
Sponsors
Coloplast A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ostomates * Male or female ≥18years * Leakage issues
Exclusion criteria
* Requires a caretaker or is unable to participate in the study * Is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Body Assessment Tool Based on the Nurse Evaluation Form | Visit 2: Week 4 | Clinical usability evaluation of the Body Assessment Tool was based on a 6-point scale (1 being lowest satisfaction - 6 being highest satisfaction) in response to the three questions: Does the tool offer value in clinical practice?, Does it provide a good starting point when choosing ostomy product(s)?, and Does it help raise the quality of care?. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) | Visit 1 (Week 0) and Visit 2 (Week 4) | The Ostomy Leak Impact (OLI) score comprises 22 questions, divided into the three domains: emotional impact (10 questions), usual and social activities (8 questions), and coping and in control (4 questions). The response to each question is rated on a 4-point Likert scale: 'all of the time', 'often', 'sometimes', and 'rarely or never' with higher scores indicating a better outcome. These responses are scored 0,1,2, and 3 respectively in the data processing. Because the domains contain a different number of questions, the score for each was transformed to the range of 0-100 to enable comparison across the three domains; the higher the score, the better level of leakage-related quality of life. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ostomates Ostomates with leakage issues and stoma created at least 3 months ago
Body Assessment Tool: Assessment tool to evaluate stoma to find proper ostomy products | 68 |
| Nurse Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate. | 22 |
| Total | 90 |
Baseline characteristics
| Characteristic | Total | Ostomates |
|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 12.1 | 67.8 years STANDARD_DEVIATION 12.1 |
| Consistency of output Liquid stool | 29 Participants | 29 Participants |
| Consistency of output Thick stool | 25 Participants | 25 Participants |
| Consistency of output Urine | 10 Participants | 10 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment Denmark | 29 participants | 29 participants |
| Region of Enrollment Finland | 12 participants | 12 participants |
| Region of Enrollment Norway | 19 participants | 19 participants |
| Region of Enrollment Sweden | 8 participants | 8 participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants |
| Type of ostomy Colostomy | 32 Participants | 32 Participants |
| Type of ostomy Ileostomy | 25 Participants | 25 Participants |
| Type of ostomy Urostomy | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 68 |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
Evaluate Body Assessment Tool Based on the Nurse Evaluation Form
Clinical usability evaluation of the Body Assessment Tool was based on a 6-point scale (1 being lowest satisfaction - 6 being highest satisfaction) in response to the three questions: Does the tool offer value in clinical practice?, Does it provide a good starting point when choosing ostomy product(s)?, and Does it help raise the quality of care?.
Time frame: Visit 2: Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stoma Care Nurses | Evaluate Body Assessment Tool Based on the Nurse Evaluation Form | Does the tool offer value in clinical practice? | 4.6 score on a scale | Standard Deviation 1.1 |
| Stoma Care Nurses | Evaluate Body Assessment Tool Based on the Nurse Evaluation Form | Does it provide a good starting point when choosing ostomy product(s)? | 5.1 score on a scale | Standard Deviation 0.8 |
| Stoma Care Nurses | Evaluate Body Assessment Tool Based on the Nurse Evaluation Form | Does it help raise the quality of care? | 4.7 score on a scale | Standard Deviation 1.3 |
Secondary
QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control)
The Ostomy Leak Impact (OLI) score comprises 22 questions, divided into the three domains: emotional impact (10 questions), usual and social activities (8 questions), and coping and in control (4 questions). The response to each question is rated on a 4-point Likert scale: 'all of the time', 'often', 'sometimes', and 'rarely or never' with higher scores indicating a better outcome. These responses are scored 0,1,2, and 3 respectively in the data processing. Because the domains contain a different number of questions, the score for each was transformed to the range of 0-100 to enable comparison across the three domains; the higher the score, the better level of leakage-related quality of life.
Time frame: Visit 1 (Week 0) and Visit 2 (Week 4)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Stoma Care Nurses | QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) | emotional impact Visit 1 | 62.1 score on a scale |
| Stoma Care Nurses | QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) | emotional impact Visit 2 | 80.0 score on a scale |
| Stoma Care Nurses | QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) | usual and social activities Visit 1 | 78.5 score on a scale |
| Stoma Care Nurses | QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) | usual and social activities Visit 2 | 89.2 score on a scale |
| Stoma Care Nurses | QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) | coping and in control Visit 1 | 67.3 score on a scale |
| Stoma Care Nurses | QoL (Based on the Three OLI Domain Scores (Emotional Impact, Usual and Social Activities, and Coping and in Control) | coping and in control Visit 2 | 83.5 score on a scale |