Nursing Interventions for Glycemic Control

NCT ID: NCT03558581

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-08-31

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.

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)

Conditions

Diabetes Mellitus; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: EXPERIMENTAL

Educational

Intervention Type: OTHER

Interventions

Educational

Intervention Type: OTHER

Other Intervention 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.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Ana Elizabeth Prado Lima Figueiredo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Capellari, Master

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidade Católica do Rio Grande do Sul

Ana Figueiredo, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidade Católica do Rio Grande do Sul

Locations

Pontificia Universidade Católica Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

EnfDiaTrial

Identifier Type: -

Identifier Source: org_study_id