Nursing Interventions for Glycemic Control
June 14, 2018 updated by: Ana Elizabeth Prado Lima Figueiredo, Pontificia Universidade Católica do Rio Grande do Sul
Introduction: Diabetes mellitus (DM) is a very frequent pathology, which can lead to renal failure and the need for renal replacement therapy.
In people with chronic kidney disease (CKD) and diabetes mellitus (DM), glycemic control is very important for the prevention of microvascular injury.
In this context, the Nursing Process (NP) is the instrument to guide care, contributing to the attention of individuals' needs.
Objective: To evaluate the results of Nursing Outcomes Classification (NOC), obtained through interventions of the Nursing Interventions Classification (NIC) for the glycemic control, in patients with diabetes in renal replacement therapy, with a diagnosis of Unstable Glycemia, of the North American Nursing Diagnosis - International (NANDA-I).
Method: Randomized clinical trial in three dialysis services in southern Brazil.
Population: Type I and II diabetes patients on hemodialysis.
Sample: Over 18 years old, literate, who accept to participate in the study by signing a Term of Consent Free and Clarified.
Exclusion criteria: severe uncorrected deficiency in hearing, speech, total amaurosis, degenerative neurological diseases, or score less than 20 in the Mini Mental State Examination.
Randomization occurred by clusters, considering dialysis shifts.
The CG followed routine treatment and guidelines, while the IG received nursing interventions on a monthly basis for 6 months.
Variables related to NOC scores and the knowledge, attitude and self-care tests for DM were applied before and after the intervention period.
After the intervention period, a washout period of 06 months will occur, after which the variables will be collected.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
After randomization, the intervention group was assesses by a nurse determining the nursing outcomes (NOC)for the specific nursing diagnosis Unstable glycemia. One educational intervention per month was done:
- Teaching: individual and Teaching: disease process.
- Control of hyperglycemia and Control of hypoglycemia.
- Teaching: prescription drugs (prescription drugs, was carried out focusing on oral hypoglycemic agents and insulin)
- Teaching: psychomotor skills ( was performed with a view to the management and application of insulin). In case of use oral antiglycemic agent the Teaching: prescription drugs and control of hyperglycaemia and hypoglycemia was repeated
- Teaching: Foot care.
- Teaching: activity / prescribed exercises. After the completion of the six intervention patients were assessed for outcome classification the study will contemplate a 6 months washout between the NOC assessment ( end of interventions and final assessment)
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90.619-900
- Pontificia Universidade Católica Rio Grande do Sul
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diabetic with chronic kidney disease on hemodialysis
- over 18 years old
- literate,
- who accept to participate in the study by signing a Term of Consent Free and Clarified
Exclusion Criteria:
- severe uncorrected deficiency in hearing, speech,
- total amaurosis,
- degenerative neurological diseases,
- score less than 20 in the Mini Mental State Examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Patients have not received any special intervention, the follow up care was the standard care for the specific clinic
|
|
|
Experimental: Intervention
After initial allocation the select patient received six educational interventions selected from Nursing Intervention Classification (NIC)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic control - HbA1< 7%
Time Frame: 1 year
|
blood sample after NIC interventions
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improve Knowledge assessed by questionaries DKNA
Time Frame: 1 year
|
DKNA has 15 multiple choice response items and covers aspects related to the general knowledge of diabetes mellitus. The questions are about basic physiology, food groups and substitutions, DM management in case of complications, and general principles of disease care). The measurement scale used is from 0 to 15. A score (1) is assigned for correct answer and zero (0) for incorrect. Score greater than eight indicates knowledge about diabetes mellitus |
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improve attitude and coping of Diabetes assessed by questionaries ATT-19
Time Frame: 1 year
|
ATT - 19, it is an instrument that seeks the psychological adjustment measure for diabetes mellitus, developed as a response to the needs of evaluation of psychological and emotional aspects of the disease.
It contains nineteen items that include six factors: a) stress associated with DM, b) receptivity to treatment, c) trust in treatment, d) personal efficacy, e) health perception, f) social acceptance, whose responses are measured through five-point Likert scale (I totally disagree - score 1, until I fully agree - score 5).
The total value of the score varies from from 19 to 95 points.
A score greater than 70 points indicates a positive attitude about the disease
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Claudia Capellari, Master, Pontificia Universidade Católica do Rio Grande do Sul
- Principal Investigator: Ana Figueiredo, PhD, Pontificia Universidade Católica do Rio Grande do Sul
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
May 1, 2018
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
April 30, 2018
First Submitted That Met QC Criteria
June 14, 2018
First Posted (Actual)
June 15, 2018
Study Record Updates
Last Update Posted (Actual)
June 15, 2018
Last Update Submitted That Met QC Criteria
June 14, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EnfDiaTrial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.