Effectiveness of Nursing Care Plans Based in Nursing Diagnoses in Metabolic Control of Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01482481|
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : November 30, 2011
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).
|Condition or disease|
|Type 2 Diabetes Mellitus Cardiovascular Risk Factors|
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
- 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 Type :||Observational|
|Actual Enrollment :||23488 participants|
|Official Title:||Effectiveness of Implementing Nursing Care Plans Based on Scientific Methodology in Improving Metabolic and Blood Pressure Control of Type 2 Diabetes Mellitus Patients.|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||November 2011|
- HbA1c level [ Time Frame: Final (before 4 years follow-up) ]
- Blood Pressure [ Time Frame: Final (before 4 years follow-up) ]
- Low-density lipoprotein (LDL) cholesterol [ Time Frame: Final (before 4 years of follow-up) ]
- Body Mass Index (BMI) [ Time Frame: Final (before 4 years of follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482481
|Gerencia Atención Primaria|
|Madrid, Spain, 28029|
|Study Director:||JUAN CARDENAS||Atención Primaria Madrid|