Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Pressure injury healing
研究概览
简要总结
Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers.
The goal of this clinical trial is to evaluate if a community-based pressure injury (PI) care bundle is effective in treating and preventing pressure injuries in home settings. It will also assess how feasible it is to implement this care bundle in Singapore's community care context.
The main questions it aims to answer are:
- Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)?
- Can the care bundle prevent the development of new pressure injuries?
- How well do caregivers learn and apply PI care knowledge after receiving the educational intervention?
- How practical and acceptable is this care bundle for use in home settings?
The investigators will compare the PI care bundle to routine care (control group) to see if the care bundle works better for managing pressure injuries at home. Success will be measured using the PUSH tool, which scores pressure injuries from 0 (completely healed) to 17 (most severe). A reduction of at least 3 points on this scale will indicate meaningful improvement.
Participants and their caregivers will:
Be split into two groups - one group will use the new care plan (receive the PI care bundle), and the other will continue with their routine care.
Have their pressure injuries checked regularly for 6 weeks. Have their caregivers learn about pressure injury care. Answer questions about how well the care plan works for them.
The investigator hopes this study will help find better ways to treat or prevent pressure injuries at home and support the caregivers at home.
详细描述
STUDY DESIGN and METHODOLOGY
This is a randomized controlled trial evaluating a community-based pressure injury (PI) care bundle versus routine care. The study employs a waitlist-control design with a 6-week intervention period.
OUTCOME MEASUREMENTS
Primary Outcome:
- Clinical improvement measured using the Pressure Ulcer Scale for Healing (PUSH) tool.
- Minimum clinically meaningful effect size established as 3-point reduction on PUSH score.
- PUSH scoring ranges from 0 (healed) to 17 (most severe)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients discharged from SGH with existing PI (any stages according to NPIAP and on any part of the body)
- •have a family caregiver or FDH who will be managing the PI upon discharge
- •patients will be discharged to home
- •living within the SGH nursing community zones
排除标准
- •previous or existing participation in this trial
- •palliative or dying patients
- •planned discharge to a nursing home or other hospital
- •mobile inpatient care@home service
- •patient or next-of-kin who refused to participate.
研究组 & 干预措施
Wait-list
The wait-list group will receive routine care during the first six weeks and at seven weeks, the index PI will be restaged and if patient is still having PI- the PI care bundle will be provided for the next six weeks. However, PI care bundle can also be initiated if the index PI advances to higher stage had increased pain over PI site or when there is deterioration of the index PI at any point during the weekly follow up.
Providing PI care bundle to wait-list control group after 6 week ensures ethical care while maintaining study integrity.
干预措施: Wait-list (Other)
Community-based PI care bundle
The community-based PI care bundle follows the aSSKINg model and is delivered in addition to routine care for six weeks.
干预措施: community-based PI care bundle (Other)
结局指标
主要结局
Pressure injury healing
时间窗: at 6 weeks post randomisation
The proportion of community-dwelling adults who achieve a reduction of at least 3 points on the PUSH score of the index PI at six weeks. The PUSH tool, with a range from 0 (healed) to 17 (worst score), provides a continuous outcome measure. The investigators have set a 3-point reduction as the minimum clinically meaningful effect size for this study.
次要结局
- Caregiver's Knowledge, Attitude and Practice (KAP)(6 weeks post randomisation)