跳至主要内容
临床试验/NCT07843888
NCT07843888尚未招募不适用

The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia: A Randomised Controlled Trial

Manisa Celal Bayar University0 个研究点目标入组 120 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Braden Pressure Ulcer Risk Assessment Scale

研究概览

简要总结

Introduction and Aim: Pressure ulcers are preventable complications that are common, particularly in individuals with dementia cared for at home, reducing quality of life and creating significant costs for the healthcare system. The risk of pressure ulcers increases in individuals with dementia due to mobility limitations, communication difficulties, and caregiver dependency; in a home care setting, the knowledge and skill deficiencies of caregivers further exacerbate this risk. The aim of this study is to evaluate the effectiveness of a multi-component training, monitoring, and reminder intervention developed for caregivers of individuals with dementia cared for at home in reducing the risk of pressure ulcers and the development of new pressure ulcers compared to standard care.

This study goes beyond the predominantly institution- and hospital-based approaches in the literature on pressure ulcer prevention, offering a structured, experimental intervention model specific to individuals with dementia cared for at home and their caregivers. This study aims to present a caregiver-based, feasible, and low-cost model for the prevention of pressure ulcers in individuals with dementia receiving home care, and to contribute the findings to scientific publications and home care services. Method: The study was designed as a two-arm, parallel-group randomized controlled experimental design. Patient-caregiver pairs (PCGs) consisting of individuals diagnosed with dementia and their primary caregivers receiving home care were randomized into intervention and control groups. The intervention group (n=60) received a 12-week multi-component program consisting of structured training sessions for caregivers, daily pressure ulcer prevention checklists, weekly coaching sessions, and text message reminders. The control group (n=60) received standard care and general information. The primary outcomes of the project were pressure ulcer risk (Braden Pressure Ulcer Risk Assessment Scale) and the development of new pressure ulcers. Secondary outcomes included caregiver knowledge level, adherence to preventive care practices, and changes in caregiver burden. The obtained data were statistically analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Patient-caregiver pairs (PCGs) consisting of individuals diagnosed with dementia and their primary caregivers receiving home care were randomised into intervention and control groups.

入排标准

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

入选标准

  • •Individuals clinically diagnosed with dementia,
  • •Home-cared for,
  • •At risk of pressure ulcers (Braden Pressure Ulcer Risk Assessment Scale ≤18),
  • •Having at least one primary caregiver, and the caregiver agreeing to participate in the study.

排除标准

  • •Presence of stage 3 or 4 pressure ulcer,
  • •Hospitalisation within the last month.

研究组 & 干预措施

Pressure Injury Prevention Education

Experimental

The intervention group (n=60) received a 12-week multi-component program consisting of structured training sessions for caregivers, daily pressure ulcer prevention checklists, weekly coaching sessions, and text message reminders.

干预措施: Pressure Injury Prevention Education (Behavioral)

Usual Care

No Intervention

Caregivers in the control group (n=60) will only receive a general informational brochure as part of standard care. No training or monitoring interventions will be applied to this group. In accordance with ethical principles, participants in the control group will also be provided with access to training materials after the study is completed.

结局指标

主要结局

Braden Pressure Ulcer Risk Assessment Scale

时间窗: This will be evaluated with T0 (baseline), T1 (week 6) and T2 (week 12) measurements.

The Braden Scale for Predicting Pressure Sore Risk consists of six subscales: sensory perception, moisture, activity, mobility, nutrition, and friction/shear. The first five subscales are scored from 1 to 4, while friction/shear is scored from 1 to 3. Total scores range from 6 to 23, with lower scores indicating a higher risk of pressure injury. Scores of ≤12 indicate high risk, 13-14 moderate risk, and 15-16 low risk. For individuals aged 75 years or older, scores of 15-18 are considered indicative of low risk.

次要结局

  • Zarit Burden Interview(Assessment will be based on T0 (baseline), T1 (week 6), and T2 (week 12) measurements.)

研究者

发起方
Manisa Celal Bayar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Uyar Açışlı

Assistant Professor

Manisa Celal Bayar University

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