Nursing Interventions for Glycemic Control

NCT03558581 | Unknown

• 1 other identifier: EnfDiaTrial
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Chronic Kidney Diseases

Keywords

Nursing Process; Nephrology Nursing; Education Health

Outcome Measures

Primary Outcomes (1)

• Glycemic control - HbA1< 7%

  blood sample after NIC interventions

  1 year

Secondary Outcomes (1)

• Improve Knowledge assessed by questionaries DKNA

  1 year

Other Outcomes (1)

• Improve attitude and coping of Diabetes assessed by questionaries ATT-19

  1 year

Study Arms (2)

Control

NO INTERVENTION

Patients have not received any special intervention, the follow up care was the standard care for the specific clinic

Intervention

EXPERIMENTAL

After initial allocation the select patient received six educational interventions selected from Nursing Intervention Classification (NIC)

Other: Educational

Interventions

Educational OTHER

Also known as: 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• severe uncorrected deficiency in hearing, speech,
• total amaurosis,
• degenerative neurological diseases,
• score less than 20 in the Mini Mental State Examination

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Study Sites (1)

Pontificia Universidade Católica Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90.619-900, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Claudia Capellari, Master

  Pontificia Universidade Católica do Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Ana Figueiredo, PhD

  Pontificia Universidade Católica do Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 15, 2018
• Study Start: November 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: August 1, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)