跳至主要内容
临床试验/NCT07479810
NCT07479810Enrolling By Invitation不适用

A Nurse-led Intervention in General Practice to Manage People With Chronic Conditions: a Pre-post Study

Universita di Verona1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Composite Outcome - access to the emergency department or hospitalization

研究概览

简要总结

This quasi-experimental study aims to assess if a nurse-led proactive intervention can enhance self-care and reduce hospitalizations or accesses to emergency department visits in chronically ill adults over 65 years old.

The questions that it seeks to answer are the following:

  1. Can a structured, proactive nurse-led intervention reduce hospitalizations and access to emergency departments?
  2. Can this intervention improve self-care, medication adherence, and the overall quality of life?

To assess its effectiveness, researchers will evaluate health outcomes before and after carrying out the intervention.

Participants will receive an initial assessment to identify specific educational needs. To enhance self-care and symptom management, patients will participate in at least three scheduled follow-up sessions (via phone call or face-to-face) during the following six months. They will also complete questionnaires assessing lifestyle quality, medication adherence, and self-care abilities.

详细描述

The study aims to evaluate the effectiveness of managing people with chronic diseases through structured patient education, proactive healthcare, and prevention programs in primary care.

The intervention will be carried out in the outpatient setting and delivered by family and community nurses working in a Community Health Home, located in a rural district in northern Italy.

The quasi-experimental study takes place from September 2023 to September 2025.

  • Population - All patients meeting the following inclusion criteria will be included: a) diagnosed with at least one non-oncological chronic condition, b) aged over 65 years, and c) assigned to general practitioners in the district of reference of the Community Health Home. Potential participants will be referred by general practitioners, social workers, or other professionals from home care, community, and transitional care services to family and community nurses (hereafter, nurses). Nurses will collect the informed written consent to participate in the study. Patients will be recruited through a consecutive sampling. It wasn't possible to perform an a priori power analysis because there are no available data on the chosen primary endpoint.
  • Educational Intervention - The intervention will involve nurses proactively caring for patients with chronic conditions based on the Chronic Care Model approach and the Middle Range Theory of self-care in chronic disease, focusing on behavior change, engagement and empowerment, self-care and symptom perception, and health promotion planning strategies.

This process will be initiated through a phone call, during which the service will be introduced, and an appointment will be scheduled for either an outpatient or home nursing visit, depending on the patient's ability to access the Community Health Home. Following the initial structured assessment interview, patients will receive structured follow-up care with at least three contacts over six months. The frequency of these contacts will be increased at the nurse's discretion in cases of poor self-care ability or multiple educational needs identified during the initial interview. The follow-up will consist of in-person visits alternated with telephone follow-ups, focusing on self-care skill development and clinical monitoring.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Diagnosed with at least one non-oncological chronic condition;
  • Aged over 65 years;
  • Assigned to general practitioners in the district of reference of the Community Health Home.

排除标准

  • Life expectancy of less than 12 months, as assessed by the general practitioner;
  • Having more than one home access a week of intensive home care.

研究组 & 干预措施

Intervention

Other

Single arm

干预措施: Proactive Intervention (Other)

结局指标

主要结局

Composite Outcome - access to the emergency department or hospitalization

时间窗: 6 and 12 months pre-post

The number of patients with at least one event between: * access to the emergency department for pathological causes related to the chronic disease; * hospitalization for related pathological causes. Data will be collected from hospital integrated databases (Atlante, HR suite) from authorized employed healthcare professionals.

次要结局

  • Result endpoint: Medication adherence.(6 and 12 months after the intervention)
  • Result endpoint: Self-care ability(6 and 12 months after the intervention)
  • Result endpoint: Quality of received care(6 and 12 months after the intervention)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federica Canzan

Associate Professor

Universita di Verona

研究点 (1)

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