Nursing Interventions for Glycemic Control

Diabetes Mellitus Clinical Trial

Official title:

Nursing Interventions for Glycemic Control

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03558581
• Other study ID #: EnfDiaTrial
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: June 2018
• Source: Pontificia Universidade Católica do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. Teaching: individual and Teaching: disease process.

2. Control of hyperglycemia and Control of hypoglycemia.

3. Teaching: prescription drugs (prescription drugs, was carried out focusing on oral hypoglycemic agents and insulin)

4. 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

5. Teaching: Foot care.

6. 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: August 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Educational

Locations

Country	Name	City	State
Brazil	Pontificia Universidade Católica Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidade Católica do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improve attitude and coping of Diabetes assessed by questionaries ATT-19	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
Primary	Glycemic control - HbA1< 7%	blood sample after NIC interventions	1 year
Secondary	Improve Knowledge assessed by questionaries DKNA	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