Effectiveness of Nursing Care Plans Based in Nursing Diagnoses in Metabolic Control of Type 2 Diabetes Mellitus

Completed

• Conditions: Type 2 Diabetes Mellitus; Cardiovascular Risk Factors

• Registration Number: NCT01482481
• Lead Sponsor: Hospital Carlos III, Madrid

Brief Summary

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).

Detailed Description

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.

The primary outcome was HbA1c, lipid levels, blood pressure, and BMI after 24 and 48 months of follow-up.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-12
• Status Verified: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-11-27
• Study First Submitted QC: 2011-11-29
• Last Update Submitted: 2011-11-29
• Study First Posted: 2011-11-30
• Last Update Posted: 2011-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23488

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c level	Final (before 4 years follow-up)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gerencia Atención Primaria; 🇪🇸 Madrid, Spain