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临床试验/NCT01482481
NCT01482481已完成不适用

Effectiveness of Implementing Nursing Care Plans Based on Scientific Methodology in Improving Metabolic and Blood Pressure Control of Type 2 Diabetes Mellitus Patients.

Hospital Carlos III, Madrid1 个研究点 分布在 1 个国家目标入组 23,488 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23,488
试验地点
1
主要终点
HbA1c level

研究概览

简要总结

Background: Nurses in clinical practice implement care to patients with Type 2 diabetes mellitus (DM2) in order to maintain normal blood glucose readings, promote weight loss and provide nutrition counseling to improve metabolic and blood pressure control. Because many disciplines contribute to patient's health outcomes, it is important to distinguish how nurses contribute to patient care and the achievement of health outcomes and the differences between the use or not the classification of Nursing Diagnoses, and the Nursing Interventions Classification (NIC) in clinical practice settings.

Methods: Prospective observational study with 2-year follow-up to assess the effect of Nursing Care Plans based on Scientific Methodology (NCPSM) on changing the control parameters in routine clinical practice conditions.

Settings: 31 Primary care centers in northeastern urban area of Madrid (Spain). Subjects: 24,124 DM2 patients (full universe).

详细描述

The computerized clinical record system (CCR) form for primary care of the Madrid Health Service was used as the data source. NCPSM was identified by clinical records of NANDA and NIC nursing taxonomies, and were defined as nursing care based on the following three criteria:

Criterion 1.- A patient's CCR must register valuation data based on Marjory Gordon "functional pattern" in at least the following areas:

  • Health perception
  • Nutritional-metabolic
  • Activity-exercise. Criterion 2.- The problems identified and the proper management of treatment will be described using coded diagnoses with NANDA.

Criterion 3.- The nursing interventions carried out by standardized language will be registered according to the NIC taxonomy.

Eligibility criteria for patients were: older than 30 years of age, with previously diagnosed diabetes (cardinal clinical, plus random blood glucose >200 mg/dl or oral glucose of >200 mg/dl at 2 h, twice, or plasma fasting glucose of >126 mg/dl on two occasions or being diagnosed previously, received specific treatment for diabetes) and exclusion criteria were: gestational diabetes, patients involved in clinical trials, patients with life expectancy of less than one year (according to clinical judgment), homebound patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • older than 30 years of age,
  • with previously diagnosed diabetes (cardinal clinical, plus random blood glucose > 200 mg/dl or oral glucose of >200 mg/dl at 2 h, twice, or plasma fasting glucose of >126 mg/dl on two occasions or being diagnosed previously, received specific treatment for diabetes)

排除标准

  • gestational diabetes,
  • patients involved in clinical trials,
  • patients with life expectancy of less than one year (according to clinical judgment),
  • homebound patients

结局指标

主要结局

HbA1c level

时间窗: Final (before 4 years follow-up)

次要结局

  • Low-density lipoprotein (LDL) cholesterol(Final (before 4 years of follow-up))
  • Body Mass Index (BMI)(Final (before 4 years of follow-up)
  • Blood Pressure(Final (before 4 years follow-up))

研究者

发起方
Hospital Carlos III, Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel Angel Salinero Fort

MD

Hospital Carlos III, Madrid

研究点 (1)

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