Type 2 Diabetes MellitusNCT01482481
Effectiveness of Nursing Care Plans Based in Nursing Diagnoses in Metabolic Control of Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus and Cardiovascular Risk Factors, run by Hospital Carlos III, Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Risk Factors
- How many people
- 23,488 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 23,488 DM2 patients (full universe).
Who may be able to join
- 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)
Who cannot join
- gestational diabetes,
- patients involved in clinical trials,
- patients with life expectancy of less than one year (according to clinical judgment),
- homebound patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- Keywords
- Patient Care Planning, Type 2 Diabetes Mellitus, Cardiovascular Risk Factors, Primary Health Care, Spain
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level
Measured: Final (before 4 years follow-up)
Secondary outcomes (3)
Blood Pressure
Measured: Final (before 4 years follow-up)
Low-density lipoprotein (LDL) cholesterol
Measured: Final (before 4 years of follow-up)
Body Mass Index (BMI)
Measured: Final (before 4 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Carlos III, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Gerencia de Atención Primaria, Madrid
- Responsible party
- Principal investigator, Miguel Angel Salinero Fort, Hospital Carlos III, Madrid
- Investigators
- JUAN CARDENAS, Study director, Atención Primaria Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482481
- Sponsor's protocol ID
- PI070865
- Other IDs
- 070865
- Status last verified
- Nov 2011
- First submitted
- 27 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22952794
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01482481
- Acronym / sponsor ID
- PI070865
- Keywords
- Patient Care Planning, Type 2 Diabetes Mellitus, Cardiovascular Risk Factors, Primary Health Care, Spain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,488 participants (actual)
- Lead sponsor
- Hospital Carlos III, MadridUniversity, hospital or other
- Collaborators
- Gerencia de Atención Primaria, Madrid
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 23,488 DM2 patients (full universe).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- gestational diabetes,
- patients involved in clinical trials,
- patients with life expectancy of less than one year (according to clinical judgment),
- homebound patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c level
Time frame: Final (before 4 years follow-up)
3 secondary outcomes
Blood Pressure
Time frame: Final (before 4 years follow-up)
Low-density lipoprotein (LDL) cholesterol
Time frame: Final (before 4 years of follow-up)
Body Mass Index (BMI)
Time frame: Final (before 4 years of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
- Derived from this study: PubMed 22952794Cardenas-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JUAN CARDENAS study director
Atención Primaria Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Cardiovascular Risk Factors, run by Hospital Carlos III, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c level (time frame: Final (before 4 years follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01482481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.