Nursing Interventions for Glycemic Control

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: Diabetes Mellitus; Chronic Kidney Diseases
• Intervention / Treatment: Other: Educational

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:

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)

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90.619-900
      • Pontificia Universidade Católica Rio Grande do Sul

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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: Educational; Other Names: Teaching: individual and Teaching: disease process.; Control of hyperglycemia and Control of hypoglycemia.; Teaching: prescription drugs; Teaching: psychomotor skills.; Teaching: Foot care.; Teaching: activity / prescribed exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control - HbA1< 7%	blood sample after NIC interventions	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pontificia Universidade Católica do Rio Grande do Sul
• 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

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

• Keywords: Nursing Process; Nephrology Nursing; Education Health
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• 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