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临床试验/NCT04944186
NCT04944186已完成不适用

The Effect of Structured Pressure Injury Patient Education Program on Knowledge, Participation, Wound Healing Progress and Quality of Life Among Patient With Limited Mobility

University of Malaya2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
2
主要终点
Knowledge

研究概览

简要总结

This study was planned as a prospective quasi-experimental study with the control group to determine the effect of structured pressure injury patient education (program on the knowledge, participation, wound healing progress, and quality of life among patients with limited mobility. We hypothesized that there would be a significant effect of structured pressure injury patient education on patient's knowledge, participation, wound healing rate, and quality of life between the control and intervention group over time.

详细描述

Patients with limited mobility and pressure injury are always at higher risk of having multiple functional, social, psychological, and financial repercussions. Without intensive PI management and prevention, these populations continue to suffer from prolonged pain, infection, social isolation, and exacerbation of mental health conditions.

While many preventive strategies and management are available to ease patient burden due to pressure injury, involving patient to take part in their care make a huge difference in patient outcome. In Malaysia, nurses play an important role in providing patient education on pressure injury, usually delivered through informal routine care, by distributing information leaflet or via digital resources on the Ministry of Health's website. However, the existing pressure injury education content is too broad, only emphasizing pressure injury prevention and no information on pressure injury care.

Few pieces of evidence reported on the effectiveness of patient education were able to improve patient knowledge on PI, increase patient participation in PI care associate with wound healing and improve the quality of life. However, there is a content gap in pressure injury patient education, which is wound care. While there a lot of patient education on pressure injury had been conducted extensively in the literature review, the components of wound care in pressure injury patient education are still unclear. Thus the primary objective of this study is to identify the effect of structured pressure injury patient education on the knowledge, participation, wound healing progress, and quality of life among patients with limited mobility. We hypothesized that there would be a significant effect of structured pressure injury patient education compared to the standard patient education on patient's knowledge, participation, wound healing rate, and quality of life between control and intervention group over time.

To achieve this research objective, we opt to conduct a quasi-experimental study-calculation of sample size is by using STATA 12.0 program. To calculate the sample size, power at 80%, and alpha was pre-set at 0.05. Mean, and standard deviation (σ) were extracted from previous researcher. Based on the calculation, a total of 120 eligible samples will be recruited with 60 samples each arm.

The patients included in the study will be assigned to the experimental group (structured pressure injury patient education) and control group (standard patient education). Eight medical-surgical wards including rehabilitation ward with a high prevalence of pressure injury were identified and invited to participate. Four wards agreed (medical ward, two multidisciplinary wards, and orthopedic ward), and the rest unable to participates because allocated as active COVID-19 ward. Thus, potential participants for this study will be recruited in these four wards in this tertiary hospital. The process of data collection will be started with control group first and followed by intervention group. Considering the limited availability of the target population set in the inclusion criteria earlier, the researcher opts to use convenience sampling.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient must be literate in either Malay or English language.
  • Patients with PI stage II or stage III according to NPIAP staging of PI.
  • PI located either at sacrococcygeal / greater trochanter/ischial tuberosities.
  • Braden score 18 or less; with limited mobility
  • Absence of any active malignant, hematological problem or psychiatric disease

排除标准

  • Immunocompromised
  • Having urinary/fecal incontinence
  • Comatose patient or who are unable to respond verbally and cognitively impaired
  • Patient who will undergo flap or skin graft surgery

结局指标

主要结局

Knowledge

时间窗: 8 weeks

Pressure Injury Knowledge (%)

Patient Participation

时间窗: 8 weeks

Patient Participation on Pressure Injury Prevention (%)

Wound-healing progress

时间窗: 8 weeks

Pressure injury condition includes size, exudate and tissue type (Score 0 -17). 0 minimum points indicate wound completely heal. Increasing number of score indicate wound condition is worsening. 17 maximum points represents a serious PI with wound area more than 24cm2 of of size, heavy exudate, and non-viable tissue.

Pressure ulcer-specific symptoms and functional outcomes

时间窗: 8 weeks

Pressure ulcer-specific symptoms and functional outcomes is assessed by the Pressure Ulcer Quality of Life (PU-QOL)

次要结局

  • Effectiveness of mySPIPE on Pressure ulcer-specific symptoms and functional outcomes(8 weeks)
  • Effectiveness of mySPIPE on PI knowledge(8 weeks)
  • Effectiveness of mySPIPE on Patient participation on PI prevention(8 weeks)
  • Effectiveness of SPIPE on Wound Healing Progress(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deena @ Clare Thomas

Principal Investigator

University of Malaya

研究点 (2)

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