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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostomates | Ostomates with leakage issues and stoma created at least 3 months ago |
| |
| Stoma care nurses | Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate. Invitations were sent to stoma care nurses randomly selected from among those working in relatively large stoma care clinics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Assessment Tool | Other | Assessment tool to evaluate stoma to find proper ostomy products |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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?". | Visit 2: Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Ostomates with leakage problems in need for stoma care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast Denmark A/s | Humlebæk | 3050 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Stoma Care Nurses | Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Nurse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Stoma care nurses performed an evaluation of the clinical usability of the Body Assessment Tool on the Ostomates and baseline characteristics for the nurses themselves was therefore not collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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?". | Posted | Mean | Standard Deviation | score on a scale | Visit 2: Week 4 |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catarina Sternhufvud | Coloplast AB | +46 (0)705 56 10 97 | secast@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2020 | Dec 22, 2023 | Prot_SAP_000.pdf |
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| Clinical usability evaluation of the Body Assessment Tool |
| Other |
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. |
|
| Visit 1 (Week 0) and Visit 2 (Week 4) |
Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 2 participants had missing data in Ostomates group Stoma care nurses performed an evaluation of the clinical usability of the Body Assessment Tool on the Ostomates and baseline characteristics for the nurses themselves was therefore not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Stoma care nurses performed an evaluation of the clinical usability of the Body Assessment Tool on the Ostomates and baseline characteristics for the nurses themselves was therefore not collected. | Number | participants |
|
| Type of ostomy | 1 individual with missing data in Ostomates group Stoma care nurses performed an evaluation of the clinical usability of the Body Assessment Tool on the Ostomates and baseline characteristics for the nurses themselves was therefore not collected. | Count of Participants | Participants |
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| Consistency of output | 4 individuals with missing data in Ostomates group Stoma care nurses performed an evaluation of the clinical usability of the Body Assessment Tool on the Ostomates and baseline characteristics for the nurses themselves was therefore not collected. | Count of Participants | Participants |
|
| Participants |
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| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Visit 1 (Week 0) and Visit 2 (Week 4) |
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| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
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| Urostomy |
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| usual and social activities Visit 2 |
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| coping and in control Visit 1 |
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| coping and in control Visit 2 |
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