Pressure InjuryNCT06128005
Pressure Injury、Caregiver、Knowledge Translation
A study testing knowledge translation in nursing for pressure injury care in people with Pressure Injury and Pressure Ulcer, run by Yi-Syuan Lai at 1 site in Taiwan.
Trial summary
Background and importance: In 2003, a pressure injury is listed as one of the indicators of care quality in clinical setting by Taiwan joint commission on hospital accreditation. That reflects that a pressure injury is a significant heath care issue. Read more about this study
- Who is it for?
- Ages 0 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Pressure Ulcer
- What is being tested?
- knowledge translation in nursing for pressure injury care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2020to 2 Jun 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 0 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Grade 1-3 pressure injury diagnosed by medical staff.
- The patient needs to have a caregiver.
- The patient and the caregiver need to be older than 20 years old, (4) The informed consent of this study.
- The caregiver Those who understand the content of health education (MMSE>24 points)
Who cannot join
- The patient has >3 disease diagnoses,
- The patient is diagnosed by a doctor as a terminally ill patient or the life expectancy is less than 3 months,
- There is a life-threatening acute problem (active bleeding site, acute myocardial infarction, acute bronchitis, etc. ),
- pressure injury caused by invasive pipeline placement,
- need to wear non-invasive positive pressure respirator, (6) need to stay in intensive care center for a long time (>10 days),
- need a long time For surgical patients, each operation takes > 5 hours,
Show all 9Show fewer
- the caregiver has dementia,
- the caregiver has mental illness or alcohol and drug addiction,
- no caregiver.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Vivian
Keelung, Zhongzheng District
Y-isyuan Lai
About this study
Official title: Evaluate Knowledge Translation Care Plan on Knowledge, Attitude, and Practice of Caregivers and Care Effects of Patients With Pressure Injury
Background and importance:
In 2003, a pressure injury is listed as one of the indicators of care quality in clinical setting by Taiwan joint commission on hospital accreditation. That reflects that a pressure injury is a significant heath care issue. Nowadays, it still constantly happens at hospitals, home, and nursing homes: Pressure injuries cause pain, and increase length of hospital stay, rehospitalization rate, and death rate. In current clinical practice, standardized guidelines and basic principles are followed for pressure injury management, and it is found that most of the caregivers are unsure about what are the consequences of having pressure injuries and how to manage and prevent them. Therefore, the caregivers are more passive, and feel nervous and confused. In literature, there are guidelines for pressure injury prevention and management. However, they are primarily designed for heath professionals. As a result, to achieve evidence-based practice and knowledge translation, I hope to make individual management plans for each patient, provide caring support, and follow up with patients. And caregivers can benefit from knowledge, attitude, practice, and caring effect.
Read the detailed description
Goals:
The study aims to achieve knowledge translation in nursing for pressure injury care. The caregivers of patients with pressure injuries and their family can benefit from translating of knowledge, attitude, and practice, and they can have more knowledge related to pressure injuries, and learn how to react to and care for patients. In this way, it will be possible to promote wound healing and prevent recurrence of pressure injuries.
Method:
This study is a randomized controlled trial. There are seventy participants. The experimental group receives care plans in which knowledge translation is applied, and the control group receives usual care. Generalized estimating equations, GEE, is used to assess the effectiveness of care plans with knowledge translation for patients and family with pressure injuries.
- Conditions
- Pressure Injury, Pressure Ulcer
- Being tested
- knowledge translation in nursing for pressure injury care
- Keywords
- caregiver, nursing plan
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knowledge translation in nursing for pressure injury careBehavioural
Pressure injury's knowledge and healing of wound.
| Study group | Role | What they receive |
|---|---|---|
| knowledge translation in nursing for pressure injury care | Experimental | Using guideline and evidence based practice for pressure injury. The experimental group has received knowledge translation in nursing for pressure injury care with precaution teaching plan by using self-designed teaching materials, manuals, videoes, multimedia tools (power point, LINE official account, LINE one-on-one lesson, virtual lesson), in-person assistance and assessment in 12weeks. Receives: Behavioral: knowledge translation in nursing for pressure injury care |
| Regular care | Placebo comparator | The controlled group maintained the regular nursing intervention. Receives: Behavioral: knowledge translation in nursing for pressure injury care |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
PUSH tool. Measure Length x Width, Exudate Amount and Tissue Type in pressure injury.
Measured: 6 weeks and 12 weeks
caregiver's knowledge
Using a self-made questionnaire, the informal caregivers' knowledge of pressure injuries, such as: how does a pressure injury form, what are the care methods for a pressure injury, what should be prepared for wound care, methods to prevent a pressure injury, etc.
Measured: 6 weeks and 12 weeks
caregiver's attitude
Use the self-made questionnaire to understand the caregivers' attitudes towards pressure injuries, such as whether they have motivation to care for them, whether they think it is important to prevent pressure injuries, whether they are confident that they can take good care of them, etc.
Measured: 6 weeks and 12 weeks
caregiver's practice
Using a self-made questionnaire, the caregiver actually evaluates the situation of caring for the crush injury, such as: body positioning, repositioning, nutritional supply status, wound dressing change, wound grading assessment, body cleanliness, whether the protrusion of the bone is paid attention to, reducing Pressure equipment, etc.
Measured: 6 weeks and 12 weeks
Secondary outcomes (3)
The recurrence rate of pressure injury three months after intervention
Patients with reoccurrence of pressure injury/Total number of experimental group or control group*100%
Measured: 12 weeks
The rehospitalization rate
Number of patients re-admitted for pressure injuries /Total number of experimental group or control group *100%
Measured: 12 weeks
The mortality rate
The number of Patient deaths/Total number of experimental group or control group *100%
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Oct 2020
- Primary completion2 Mar 2024
- Study completion2 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi-Syuan Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi-Syuan Lai, National Defense Medical Center, Taiwan
- Investigators
- Yi-Syuan Lai, Study chair, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128005
- Sponsor's protocol ID
- pressureinjury853121
- Status last verified
- Mar 2024
- First submitted
- 11 Apr 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Evaluate on the wound healing, knowledge and caring behaviors of hospitalized patients with pressure injury
Publications
Santamaria N, Gerdtz M, Sage S, McCann J, Freeman A, Vassiliou T, De Vincentis S, Ng AW, Manias E, Liu W, Knott J. A randomised controlled trial of the effectiveness of soft silicone multi-layered foam dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: the border trial. Int Wound J. 2015 Jun;12(3):302-8. doi: 10.1111/iwj.12101. Epub 2013 May 27.
PubMed 23711244Munoz N, Posthauer ME, Cereda E, Schols JMGA, Haesler E. The Role of Nutrition for Pressure Injury Prevention and Healing: The 2019 International Clinical Practice Guideline Recommendations. Adv Skin Wound Care. 2020 Mar;33(3):123-136. doi: 10.1097/01.ASW.0000653144.90739.ad.
PubMed 32058438Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
PubMed 30664905Lin F, Wu Z, Song B, Coyer F, Chaboyer W. The effectiveness of multicomponent pressure injury prevention programs in adult intensive care patients: A systematic review. Int J Nurs Stud. 2020 Feb;102:103483. doi: 10.1016/j.ijnurstu.2019.103483. Epub 2019 Nov 21.
PubMed 31835122Jeyathevan G, Cameron JI, Craven BC, Jaglal SB. Identifying Required Skills to Enhance Family Caregiver Competency in Caring for Individuals With Spinal Cord Injury Living in the Community. Top Spinal Cord Inj Rehabil. 2019 Fall;25(4):290-302. doi: 10.1310/sci2504-290.
PubMed 31844381Tescher A, Deppisch M, Munro C, Jorgensen V, Cuddigan J. Perioperative pressure injury prevention: National Pressure Injury Advisory Panel root cause analysis toolkit 3.0. J Wound Care. 2022 Dec 1;31(Sup12):S4-S9. doi: 10.12968/jowc.2022.31.Sup12.S4.
PubMed 36475846Haesler E, Pittman J, Cuddigan J, Law S, Chang YY, Balzer K, Berlowitz D, Carville K, Kottner J, Litchford M, Moore Z, Mitchell P, Sigaudo-Roussel D. An exploration of the perspectives of individuals and their caregivers on pressure ulcer/injury prevention and management to inform the development of a clinical guideline. J Tissue Viability. 2022 Feb;31(1):1-10. doi: 10.1016/j.jtv.2021.10.008. Epub 2021 Oct 30.
PubMed 34776327Cuddigan J, Haesler E, Moore Z, Carville K, Kottner J. Development, dissemination and evaluation of a smartphone-based app for pressure ulcer/injury prevention and treatment for use at the bedside. J Wound Care. 2022 Dec 1;31(Sup12):S29-S39. doi: 10.12968/jowc.2022.31.Sup12.S29.
PubMed 36475841
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Knowledge Translation Care Plan on Knowledge, Attitude, and Practice of Caregivers and Care Effects of Patients With Pressure Injury
- ClinicalTrials.gov ID
- NCT06128005
- Acronym / sponsor ID
- pressureinjury853121
- Conditions
- Pressure Injury, Pressure Ulcer
- Keywords
- caregiver, nursing plan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yi-Syuan LaiUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (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 and importance:
In 2003, a pressure injury is listed as one of the indicators of care quality in clinical setting by Taiwan joint commission on hospital accreditation. That reflects that a pressure injury is a significant heath care issue. Nowadays, it still constantly happens at hospitals, home, and nursing homes: Pressure injuries cause pain, and increase length of hospital stay, rehospitalization rate, and death rate. In current clinical practice, standardized guidelines and basic principles are followed for pressure injury management, and it is found that most of the caregivers are unsure about what are the consequences of having pressure injuries and how to manage and prevent them. Therefore, the caregivers are more passive, and feel nervous and confused. In literature, there are guidelines for pressure injury prevention and management. However, they are primarily designed for heath professionals. As a result, to achieve evidence-based practice and knowledge translation, I hope to make individual management plans for each patient, provide caring support, and follow up with patients. And caregivers can benefit from knowledge, attitude, practice, and caring effect.
Detailed description
Goals:
The study aims to achieve knowledge translation in nursing for pressure injury care. The caregivers of patients with pressure injuries and their family can benefit from translating of knowledge, attitude, and practice, and they can have more knowledge related to pressure injuries, and learn how to react to and care for patients. In this way, it will be possible to promote wound healing and prevent recurrence of pressure injuries.
Method:
This study is a randomized controlled trial. There are seventy participants. The experimental group receives care plans in which knowledge translation is applied, and the control group receives usual care. Generalized estimating equations, GEE, is used to assess the effectiveness of care plans with knowledge translation for patients and family with pressure injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knowledge translation in nursing for pressure injury care | Experimental | Behavioral: knowledge translation in nursing for pressure injury careUsing guideline and evidence based practice for pressure injury. The experimental group has received knowledge translation in nursing for pressure injury care with precaution teaching plan by using self-designed teaching materials, manuals, videoes, multimedia tools (power point, LINE official account, LINE one-on-one lesson, virtual lesson), in-person assistance and assessment in 12weeks. |
| Regular care | Placebo comparator | Behavioral: knowledge translation in nursing for pressure injury careThe controlled group maintained the regular nursing intervention. |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Grade 1-3 pressure injury diagnosed by medical staff.
- The patient needs to have a caregiver.
- The patient and the caregiver need to be older than 20 years old, (4) The informed consent of this study.
- The caregiver Those who understand the content of health education (MMSE>24 points)
Key exclusion criteria (9 listed)
- The patient has >3 disease diagnoses,
- The patient is diagnosed by a doctor as a terminally ill patient or the life expectancy is less than 3 months,
- There is a life-threatening acute problem (active bleeding site, acute myocardial infarction, acute bronchitis, etc. ),
- pressure injury caused by invasive pipeline placement,
- need to wear non-invasive positive pressure respirator, (6) need to stay in intensive care center for a long time (>10 days),
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 |
|---|---|---|
| knowledge translation in nursing for pressure injury carePressure injury's knowledge and healing of wound. | Behavioural | Regular care, knowledge translation in nursing for pressure injury care |
Primary outcome
wound healing
Time frame: 6 weeks and 12 weeks
PUSH tool. Measure Length x Width, Exudate Amount and Tissue Type in pressure injury.
caregiver's knowledge
Time frame: 6 weeks and 12 weeks
Using a self-made questionnaire, the informal caregivers' knowledge of pressure injuries, such as: how does a pressure injury form, what are the care methods for a pressure injury, what should be prepared for wound care, methods to prevent a pressure injury, etc.
caregiver's attitude
Time frame: 6 weeks and 12 weeks
Use the self-made questionnaire to understand the caregivers' attitudes towards pressure injuries, such as whether they have motivation to care for them, whether they think it is important to prevent pressure injuries, whether they are confident that they can take good care of them, etc.
caregiver's practice
Time frame: 6 weeks and 12 weeks
Using a self-made questionnaire, the caregiver actually evaluates the situation of caring for the crush injury, such as: body positioning, repositioning, nutritional supply status, wound dressing change, wound grading assessment, body cleanliness, whether the protrusion of the bone is paid attention to, reducing Pressure equipment, etc.
3 secondary outcomes
The recurrence rate of pressure injury three months after intervention
Time frame: 12 weeks
The rehospitalization rate
Time frame: 12 weeks
The mortality rate
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 23711244Santamaria N, Gerdtz M, Sage S, McCann J, Freeman A, Vassiliou T, De Vincentis S, Ng AW, Manias E, Liu W, Knott J. A randomised controlled trial of the effectiveness of soft silicone multi-layered foam dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: the border trial. Int Wound J. 2015 Jun;12(3):302-8. doi: 10.1111/iwj.12101. Epub 2013 May 27.
- Background: PubMed 32058438Munoz N, Posthauer ME, Cereda E, Schols JMGA, Haesler E. The Role of Nutrition for Pressure Injury Prevention and Healing: The 2019 International Clinical Practice Guideline Recommendations. Adv Skin Wound Care. 2020 Mar;33(3):123-136. doi: 10.1097/01.ASW.0000653144.90739.ad.
- Background: PubMed 30664905Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.
- Background: PubMed 31835122Lin F, Wu Z, Song B, Coyer F, Chaboyer W. The effectiveness of multicomponent pressure injury prevention programs in adult intensive care patients: A systematic review. Int J Nurs Stud. 2020 Feb;102:103483. doi: 10.1016/j.ijnurstu.2019.103483. Epub 2019 Nov 21.
- Background: PubMed 31844381Jeyathevan G, Cameron JI, Craven BC, Jaglal SB. Identifying Required Skills to Enhance Family Caregiver Competency in Caring for Individuals With Spinal Cord Injury Living in the Community. Top Spinal Cord Inj Rehabil. 2019 Fall;25(4):290-302. doi: 10.1310/sci2504-290.
- Background: PubMed 36475846Tescher A, Deppisch M, Munro C, Jorgensen V, Cuddigan J. Perioperative pressure injury prevention: National Pressure Injury Advisory Panel root cause analysis toolkit 3.0. J Wound Care. 2022 Dec 1;31(Sup12):S4-S9. doi: 10.12968/jowc.2022.31.Sup12.S4.
- Background: PubMed 34776327Haesler E, Pittman J, Cuddigan J, Law S, Chang YY, Balzer K, Berlowitz D, Carville K, Kottner J, Litchford M, Moore Z, Mitchell P, Sigaudo-Roussel D. An exploration of the perspectives of individuals and their caregivers on pressure ulcer/injury prevention and management to inform the development of a clinical guideline. J Tissue Viability. 2022 Feb;31(1):1-10. doi: 10.1016/j.jtv.2021.10.008. Epub 2021 Oct 30.
- Background: PubMed 36475841Cuddigan J, Haesler E, Moore Z, Carville K, Kottner J. Development, dissemination and evaluation of a smartphone-based app for pressure ulcer/injury prevention and treatment for use at the bedside. J Wound Care. 2022 Dec 1;31(Sup12):S29-S39. doi: 10.12968/jowc.2022.31.Sup12.S29.
- Individual participant dataSharing planned: Yes. Evaluate on the wound healing, knowledge and caring behaviors of hospitalized patients with pressure injury
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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.
Yi-Syuan Lai study chair
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knowledge translation in nursing for pressure injury care in people with Pressure Injury and Pressure Ulcer, run by Yi-Syuan Lai 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Syuan Lai (886-0925810218, family8531@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 6 weeks and 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06128005, which also lists 8 linked publications.
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 21 Mar 2024.