DermatitisNCT06835192
Impact of Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart
A study testing Experimental group in people with Dermatitis and Knowledge, Attitudes, Practice, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: Knowledge, attitudes, and behaviors regarding the prevention and care of incontinence-associated dermatitis (IAD) need to be enhanced through educational training. There is a lack of innovative courses and convenient tools to assist nursing staff in learning and teaching in clinical settings. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Knowledge, Attitudes, Practice
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- (1)Nurses in the eight adult wards.
Who cannot join
- New nurses had not completed the three-month probation period;
- Nurses are holding administrative management positions
- Nurse practitioners;
- Nurses who expected to be employed within six months due to job transitions.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University
Kaohsiung City, 801
About this study
Official title: Impact of Combining Course on Incontinence-associated Dermatitis Prevention and Management with Directive Wheel Chart for Nurses in Adult Wards
Background: Knowledge, attitudes, and behaviors regarding the prevention and care of incontinence-associated dermatitis (IAD) need to be enhanced through educational training. There is a lack of innovative courses and convenient tools to assist nursing staff in learning and teaching in clinical settings.
Purpose: This study aims to investigate the learning outcomes of nursing staff in adult wards regarding the prevention and care of IAD, comparing the effectiveness of a course combined with an Directive Wheel Chart versus a course alone. Additionally, the study examines the effectiveness of nursing staff applying the course and Directive Wheel Chart in peer teaching.
Read the detailed description
Design: This study was a two-phase randomized controlled trial conducted at a regional teaching hospital in Taiwan.
Materials and Methods: The study involved eight wards, comprising a total of 106 nurses, who were initially randomly assigned to either an experimental group (EG) or a control group (CG). Subsequently, the nurses within each ward were randomly allocated to two phases. The researcher delivered a 50-minute lecture to both groups, providing the IAD directive wheel chart only to the nurses in the EG. After a two-weeks period, one or two nurses from each ward in the first phase utilized the same course and directive wheel chart to peer-teach the nurses in the second phase within the same wards. The Chinese version of the Knowledge, Attitudes and Practices of Incontinence-associated Dermatitis Questionnaire (KAP-IAD-Q-C) and the Chinese version of the attitude towards the prevention of incontinence-associated dermatitis instrument (APrIAD-C) were employed to evaluate effectiveness. The Generalized Estimating Equation (GEE) was utilized to analyze the effectiveness of the educational intervention for each phase.
- Conditions
- Dermatitis, Knowledge, Attitudes, Practice
- Being tested
- Experimental group, Control Group
- Keywords
- Attitude, Course, Directive wheel chart, Incontinence-associated dermatitis, Knowledge, Practice
- Medical subject headings
- Dermatitis, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Also called Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart
Initially, the first author presented a 25-minute lecture with a PowerPoint presentation to the nurses of the EG. Following this, each nurse received an IAD directive wheel chart. In the subsequent 25 minutes, the first author presented three clinical cases examples and relevant information, encouraging the nurses to utilize the IAD directive wheel chart in groups. To conclude the session, a 5-minute quiz was conducted, featuring five actual clinical photographs. After the course, the nurses were instructed to take the IAD directive wheel chart back to their clinics for review and use in health education and teaching.
Control GroupOther
Also called Incontinence-associated Dermatitis Prevention and Management Course
The first author conducted a 25-minute knowledge lecture for the nurses in the CG on the same topics covered in the EG. This lecture included an explanation of IAD, its causes, the latest global classification of IAD, as well as methods for skin prevention and IAD care. Following the lecture, the same three clinical examples presented in the EG were discussed for an additional 20 minutes, during which the nurses were divided into groups for case discussions. Finally, a 5-minute quiz competition was held, featuring the same five actual clinical photographs used in the EG.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart Receives: Other: Experimental group; Other: Control Group |
| Control Group | Other | The first author conducted a 25-minute knowledge lecture for the nurses in the CG on the same topics covered in the EG. This lecture included an explanation of IAD, its causes, the latest global classification of IAD, as well as methods for skin prevention and IAD care. Following the lecture, the same three clinical examples presented in the EG were discussed for an additional 20 minutes, during which the nurses were divided into groups for case discussions. Finally, a 5-minute quiz competition was held, featuring the same five actual clinical photographs used in the EG. Receives: Other: Experimental group; Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incontinence associated dermatitis knowledge, attitude and practice questionnaire (KAP-IAD-Q)
The total score ranges from 22 to 110 with higher scores indicating better the knowledge, attitude, and practical behaviors concerning IAD.
Measured: Four weeks prior to the course, after the teaching courses, four weeks after the course
The attitude towards the prevention of incontinence-associated dermatitis instrument (APrIAD)
The questionnaire consists of 14 questions, each scored on a 4-point Likert scale., with a total score ranging from 0 to 42.
Measured: Four weeks prior to the course, after the teaching courses, four weeks after the course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Mar 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pretest-posttest design
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Ting Su, BSN, Principal investigator, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835192
- Sponsor's protocol ID
- KMUHIRB-E(I)-20240128
- Status last verified
- Oct 2024
- First submitted
- 18 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combining Course on Incontinence-associated Dermatitis Prevention and Management with Directive Wheel Chart for Nurses in Adult Wards
- ClinicalTrials.gov ID
- NCT06835192
- Acronym / sponsor ID
- KMUHIRB-E(I)-20240128
- Conditions
- Dermatitis, Knowledge, Attitudes, Practice
- Keywords
- Attitude, Course, Directive wheel chart, Incontinence-associated dermatitis, Knowledge, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Knowledge, attitudes, and behaviors regarding the prevention and care of incontinence-associated dermatitis (IAD) need to be enhanced through educational training. There is a lack of innovative courses and convenient tools to assist nursing staff in learning and teaching in clinical settings.
Purpose: This study aims to investigate the learning outcomes of nursing staff in adult wards regarding the prevention and care of IAD, comparing the effectiveness of a course combined with an Directive Wheel Chart versus a course alone. Additionally, the study examines the effectiveness of nursing staff applying the course and Directive Wheel Chart in peer teaching.
Detailed description
Design: This study was a two-phase randomized controlled trial conducted at a regional teaching hospital in Taiwan.
Materials and Methods: The study involved eight wards, comprising a total of 106 nurses, who were initially randomly assigned to either an experimental group (EG) or a control group (CG). Subsequently, the nurses within each ward were randomly allocated to two phases. The researcher delivered a 50-minute lecture to both groups, providing the IAD directive wheel chart only to the nurses in the EG. After a two-weeks period, one or two nurses from each ward in the first phase utilized the same course and directive wheel chart to peer-teach the nurses in the second phase within the same wards. The Chinese version of the Knowledge, Attitudes and Practices of Incontinence-associated Dermatitis Questionnaire (KAP-IAD-Q-C) and the Chinese version of the attitude towards the prevention of incontinence-associated dermatitis instrument (APrIAD-C) were employed to evaluate effectiveness. The Generalized Estimating Equation (GEE) was utilized to analyze the effectiveness of the educational intervention for each phase.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pretest-posttest design
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental group, Other: Control GroupCombining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart |
| Control Group | Other | Other: Experimental group, Other: Control GroupThe first author conducted a 25-minute knowledge lecture for the nurses in the CG on the same topics covered in the EG. This lecture included an explanation of IAD, its causes, the latest global classification of IAD, as well as methods for skin prevention and IAD care. Following the lecture, the same three clinical examples presented in the EG were discussed for an additional 20 minutes, during which the nurses were divided into groups for case discussions. Finally, a 5-minute quiz competition was held, featuring the same five actual clinical photographs used in the EG. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1)Nurses in the eight adult wards.
Key exclusion criteria (4 listed)
- New nurses had not completed the three-month probation period;
- Nurses are holding administrative management positions
- Nurse practitioners;
- Nurses who expected to be employed within six months due to job transitions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupAlso: Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel ChartInitially, the first author presented a 25-minute lecture with a PowerPoint presentation to the nurses of the EG. Following this, each nurse received an IAD directive wheel chart. In the subsequent 25 minutes, the first author presented three clinical cases examples and relevant information, encouraging the nurses to utilize the IAD directive wheel chart in groups. To conclude the session, a 5-minute quiz was conducted, featuring five actual clinical photographs. After the course, the nurses were instructed to take the IAD directive wheel chart back to their clinics for review and use in health education and teaching. | Other | Control Group, Experimental group |
| Control GroupAlso: Incontinence-associated Dermatitis Prevention and Management CourseThe first author conducted a 25-minute knowledge lecture for the nurses in the CG on the same topics covered in the EG. This lecture included an explanation of IAD, its causes, the latest global classification of IAD, as well as methods for skin prevention and IAD care. Following the lecture, the same three clinical examples presented in the EG were discussed for an additional 20 minutes, during which the nurses were divided into groups for case discussions. Finally, a 5-minute quiz competition was held, featuring the same five actual clinical photographs used in the EG. | Other | Control Group, Experimental group |
Primary outcome
The incontinence associated dermatitis knowledge, attitude and practice questionnaire (KAP-IAD-Q)
Time frame: Four weeks prior to the course, after the teaching courses, four weeks after the course
The total score ranges from 22 to 110 with higher scores indicating better the knowledge, attitude, and practical behaviors concerning IAD.
The attitude towards the prevention of incontinence-associated dermatitis instrument (APrIAD)
Time frame: Four weeks prior to the course, after the teaching courses, four weeks after the course
The questionnaire consists of 14 questions, each scored on a 4-point Likert scale., with a total score ranging from 0 to 42.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Ting Su, BSN principal investigator
Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Dermatitis and Knowledge, Attitudes, Practice, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incontinence associated dermatitis knowledge, attitude and practice questionnaire (KAP-IAD-Q) (time frame: Four weeks prior to the course, after the teaching courses, four weeks after the course). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.