NCT06128005

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3.4 years

First QC Date

April 11, 2022

Last Update Submit

March 20, 2024

Conditions

Keywords

caregivernursing plan

Outcome Measures

Primary Outcomes (4)

  • wound healing

    PUSH tool. Measure Length x Width, Exudate Amount and Tissue Type in pressure injury.

    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.

    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.

    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.

    6 weeks and 12 weeks

Secondary Outcomes (3)

  • The recurrence rate of pressure injury three months after intervention

    12 weeks

  • The rehospitalization rate

    12 weeks

  • The mortality rate

    12 weeks

Study Arms (2)

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.

Behavioral: knowledge translation in nursing for pressure injury care

Regular care

PLACEBO COMPARATOR

The controlled group maintained the regular nursing intervention.

Behavioral: knowledge translation in nursing for pressure injury care

Interventions

Pressure injury's knowledge and healing of wound.

Regular careknowledge translation in nursing for pressure injury care

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • (5) The caregiver Those who understand the content of health education (MMSE\>24 points)

You may not qualify if:

  • 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,
  • the caregiver has dementia,
  • the caregiver has mental illness or alcohol and drug addiction,
  • no caregiver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vivian

Keelung, Zhongzheng District, Taiwan

RECRUITING

Related Publications (8)

  • 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.

    PMID: 23711244BACKGROUND
  • Munoz 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.

    PMID: 32058438BACKGROUND
  • Mervis 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.

    PMID: 30664905BACKGROUND
  • Lin 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.

    PMID: 31835122BACKGROUND
  • Jeyathevan 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.

    PMID: 31844381BACKGROUND
  • Tescher 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.

    PMID: 36475846BACKGROUND
  • Haesler 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.

    PMID: 34776327BACKGROUND
  • Cuddigan 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.

    PMID: 36475841BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Nursing

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Yi-Syuan Lai

    Student

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

April 11, 2022

First Posted

November 13, 2023

Study Start

October 1, 2020

Primary Completion

March 2, 2024

Study Completion

June 2, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Evaluate on the wound healing, knowledge and caring behaviors of hospitalized patients with pressure injury

Shared Documents
CSR
Time Frame
When I will complete the research, that can be sharing forever.
Access Criteria
Anyone have pressure injury's problem

Locations