Trial Outcomes & Findings for The Nordic Consensus Study (NCT NCT04763863)
NCT ID: NCT04763863
Last Updated: 2024-09-05
Results Overview
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?".
Recruitment status
COMPLETED
Target enrollment
121 participants
Primary outcome timeframe
Visit 2: Week 4
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
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
|
Stoma Care Nurses
Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
22
|
|
Overall Study
COMPLETED
|
68
|
22
|
|
Overall Study
NOT COMPLETED
|
31
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Ostomates
n=68 Participants
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
|
Nurse
n=22 Participants
Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 12.1 • n=68 Participants • 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.
|
—
|
67.8 years
STANDARD_DEVIATION 12.1 • n=68 Participants • 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.
|
|
Sex: Female, Male
Female
|
40 Participants
n=66 Participants • 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.
|
—
|
40 Participants
n=66 Participants • 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.
|
|
Sex: Female, Male
Male
|
26 Participants
n=66 Participants • 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.
|
—
|
26 Participants
n=66 Participants • 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.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
29 participants
n=68 Participants • 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.
|
—
|
29 participants
n=68 Participants • 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.
|
|
Region of Enrollment
Sweden
|
8 participants
n=68 Participants • 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.
|
—
|
8 participants
n=68 Participants • 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.
|
|
Region of Enrollment
Norway
|
19 participants
n=68 Participants • 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.
|
—
|
19 participants
n=68 Participants • 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.
|
|
Region of Enrollment
Finland
|
12 participants
n=68 Participants • 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.
|
—
|
12 participants
n=68 Participants • 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 of ostomy
Colostomy
|
32 Participants
n=67 Participants • 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.
|
—
|
32 Participants
n=67 Participants • 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.
|
|
Type of ostomy
Ileostomy
|
25 Participants
n=67 Participants • 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.
|
—
|
25 Participants
n=67 Participants • 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.
|
|
Type of ostomy
Urostomy
|
10 Participants
n=67 Participants • 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.
|
—
|
10 Participants
n=67 Participants • 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.
|
|
Consistency of output
Thick stool
|
25 Participants
n=64 Participants • 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.
|
—
|
25 Participants
n=64 Participants • 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.
|
|
Consistency of output
Liquid stool
|
29 Participants
n=68 Participants • 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.
|
—
|
29 Participants
n=68 Participants • 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.
|
|
Consistency of output
Urine
|
10 Participants
n=68 Participants • 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.
|
—
|
10 Participants
n=68 Participants • 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.
|
PRIMARY outcome
Timeframe: Visit 2: Week 4Clinical 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?".
Outcome measures
| Measure |
Stoma Care Nurses
n=22 Participants
Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Outcome measures
| Measure |
Stoma Care Nurses
n=68 Participants
Stoma care nurses from Denmark, Finland, Norway and Sweden who had agreed to participate.
|
|---|---|
|
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
Interval 56.1 to 68.1
|
|
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
Interval 74.1 to 86.0
|
|
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
Interval 73.1 to 83.8
|
|
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
Interval 83.6 to 94.7
|
|
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
Interval 60.8 to 73.7
|
|
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
Interval 77.0 to 89.9
|
Adverse Events
Ostomates
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place