- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01482481
Effectiveness of Nursing Care Plans Based in Nursing Diagnoses in Metabolic Control of Type 2 Diabetes Mellitus
Effectiveness of Implementing Nursing Care Plans Based on Scientific Methodology in Improving Metabolic and Blood Pressure Control of Type 2 Diabetes Mellitus Patients.
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).
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28029
- Gerencia Atencion Primaria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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HbA1c level
Time Frame: Final (before 4 years follow-up)
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Final (before 4 years follow-up)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Blood Pressure
Time Frame: Final (before 4 years follow-up)
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Final (before 4 years follow-up)
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Low-density lipoprotein (LDL) cholesterol
Time Frame: Final (before 4 years of follow-up)
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Final (before 4 years of follow-up)
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Body Mass Index (BMI)
Time Frame: Final (before 4 years of follow-up
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Final (before 4 years of follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: JUAN CARDENAS, Atención Primaria Madrid
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI070865
- 070865 (Other Grant/Funding Number: Instituto de la Salud Carlos III)
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