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临床试验/NCT01877681
NCT01877681已完成2 期

Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction

Basque Health Service0 个研究点目标入组 58 人开始时间: 2012年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
58
主要终点
healing progression

研究概览

简要总结

Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC) can improve the effectiveness of interventions and cost savings.

Objective: To evaluate the effectiveness and costs reduction after the implementation in PC setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses for the management of PU in patients in home care setting.

Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza will be randomly assigned to two parallel groups: experimental group and control group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III. The intervention will consist of a telematic advice from the reference nurse regarding chronic wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of the intervention, multilevel models or linear mixed models to take into account the auto-correlation at the individual level and nurse, will be used

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia)

排除标准

  • Patients with chronic wounds that are not PU
  • PU in patients with plastic surgery
  • Patients who move periodically
  • Patients requiring hospitalization during follow-up
  • Patients in which nurse is expected to be changed during follow-up
  • Terminal patients

结局指标

主要结局

healing progression

时间窗: 8 weeks

healing progression as measured by the RESVECH scale by a blinded expert

次要结局

未报告次要终点

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Cristina Quesada

Nurse

Basque Health Service

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