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Completed

NCT Number: NCT01482481

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

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).

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gerencia Atención Primaria

Madrid, 28029, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HbA1c level

    Time frame: Final (before 4 years follow-up)

Secondary outcomes

  1. Blood Pressure

    Time frame: Final (before 4 years follow-up)

  2. Low-density lipoprotein (LDL) cholesterol

    Time frame: Final (before 4 years of follow-up)

  3. Body Mass Index (BMI)

    Time frame: Final (before 4 years of follow-up

Sponsors and collaborators

Lead sponsor

Hospital Carlos III, Madrid

Other

Collaborators

  • Gerencia de Atención Primaria, Madrid

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Nov 30, 2011
Registry last updated
Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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