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Nursing Interventions for Glycemic Control

Primary Purpose

Diabetes Mellitus, Chronic Kidney Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Educational
Sponsored by
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Nursing Process, Nephrology Nursing, Education Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pontificia Universidade Católica Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glycemic control - HbA1< 7%
blood sample after NIC interventions

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2018
Last Updated
June 14, 2018
Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03558581
Brief Title
Nursing Interventions for Glycemic Control
Official Title
Nursing Interventions for Glycemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontificia Universidade Católica do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Chronic Kidney Diseases
Keywords
Nursing Process, Nephrology Nursing, Education Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients have not received any special intervention, the follow up care was the standard care for the specific clinic
Arm Title
Intervention
Arm Type
Experimental
Arm Description
After initial allocation the select patient received six educational interventions selected from Nursing Intervention Classification (NIC)
Intervention Type
Other
Intervention Name(s)
Educational
Other Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Glycemic control - HbA1< 7%
Description
blood sample after NIC interventions
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Improve Knowledge assessed by questionaries DKNA
Description
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
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Improve attitude and coping of Diabetes assessed by questionaries ATT-19
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Capellari, Master
Organizational Affiliation
Pontificia Universidade Católica do Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Figueiredo, PhD
Organizational Affiliation
Pontificia Universidade Católica do Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidade Católica Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90.619-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Nursing Interventions for Glycemic Control

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