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

November 27, 2011
November 29, 2011
January 2008
December 2009   (final data collection date for primary outcome measure)
HbA1c level [ Time Frame: Final (before 4 years follow-up) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01482481 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

23,488 DM2 patients (full universe).

  • Type 2 Diabetes Mellitus
  • Cardiovascular Risk Factors
Not Provided
Not Provided
Cárdenas-Valladolid J, Salinero-Fort MA, Gómez-Campelo P, de Burgos-Lunar C, Abánades-Herranz JC, Arnal-Selfa R, Andrés AL. Effectiveness of standardized Nursing Care Plans in health outcomes in patients with type 2 Diabetes Mellitus: a two-year prospective follow-up study. PLoS One. 2012;7(8):e43870. doi: 10.1371/journal.pone.0043870. Epub 2012 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23488
November 2011
December 2009   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01482481
PI070865, 070865
No
Miguel Angel Salinero Fort, Hospital Carlos III, Madrid
Hospital Carlos III, Madrid
Gerencia de Atención Primaria, Madrid
Study Director: JUAN CARDENAS Atención Primaria Madrid
Hospital Carlos III, Madrid
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP