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

This study has been completed.
Sponsor:
Collaborator:
Gerencia de Atención Primaria, Madrid
Information provided by (Responsible Party):
Miguel Angel Salinero Fort, Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier:
NCT01482481
First received: November 27, 2011
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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
Type 2 Diabetes Mellitus
Cardiovascular Risk Factors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Carlos III, Madrid:

Primary Outcome Measures:
  • HbA1c level [ Time Frame: Final (before 4 years follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Final (before 4 years follow-up) ] [ Designated as safety issue: No ]
  • Low-density lipoprotein (LDL) cholesterol [ Time Frame: Final (before 4 years of follow-up) ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: Final (before 4 years of follow-up ] [ Designated as safety issue: No ]

Enrollment: 23488
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

23,488 DM2 patients (full universe).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482481

Locations
Spain
Gerencia Atención Primaria
Madrid, Spain, 28029
Sponsors and Collaborators
Hospital Carlos III, Madrid
Gerencia de Atención Primaria, Madrid
Investigators
Study Director: JUAN CARDENAS Atención Primaria Madrid
  More Information

No publications provided by Hospital Carlos III, Madrid

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Miguel Angel Salinero Fort, MD, Hospital Carlos III, Madrid
ClinicalTrials.gov Identifier: NCT01482481     History of Changes
Other Study ID Numbers: PI070865, 070865
Study First Received: November 27, 2011
Last Updated: November 29, 2011
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Hospital Carlos III, Madrid:
Patient Care Planning
Type 2 Diabetes Mellitus
Cardiovascular Risk Factors
Primary Health Care
Spain

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013