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

November 29, 2011 updated by: Miguel Angel Salinero Fort, Hospital Carlos III, Madrid

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

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

Observational

Enrollment (Actual)

23488

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28029
        • Gerencia Atencion Primaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

23,488 DM2 patients (full universe).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c level
Time Frame: Final (before 4 years follow-up)
Final (before 4 years follow-up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: Final (before 4 years follow-up)
Final (before 4 years follow-up)
Low-density lipoprotein (LDL) cholesterol
Time Frame: Final (before 4 years of follow-up)
Final (before 4 years of follow-up)
Body Mass Index (BMI)
Time Frame: Final (before 4 years of follow-up
Final (before 4 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: JUAN CARDENAS, Atención Primaria Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 27, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 29, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • PI070865
  • 070865 (Other Grant/Funding Number: Instituto de la Salud Carlos III)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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