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

NCT ID: NCT01482481

Last Updated: 2011-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23488 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Cardiovascular Risk Factors

Keywords

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Patient Care Planning Type 2 Diabetes Mellitus Cardiovascular Risk Factors Primary Health Care Spain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role collaborator

Hospital Carlos III, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Miguel Angel Salinero Fort

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JUAN CARDENAS

Role: STUDY_DIRECTOR

Atención Primaria Madrid

Locations

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Gerencia Atención Primaria

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Cardenas-Valladolid J, Salinero-Fort MA, Gomez-Campelo P, de Burgos-Lunar C, Abanades-Herranz JC, Arnal-Selfa R, Andres 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.

Reference Type DERIVED
PMID: 22952794 (View on PubMed)

Other Identifiers

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070865

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI070865

Identifier Type: -

Identifier Source: org_study_id