Nursing Interventions for Glycemic Control
14. juni 2018 opdateret af: Ana Elizabeth Prado Lima Figueiredo, Pontificia Universidade Católica do Rio Grande do Sul
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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)
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
74
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasilien, 90.619-900
- Pontificia Universidade Católica Rio Grande do Sul
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Control
Patients have not received any special intervention, the follow up care was the standard care for the specific clinic
|
|
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Eksperimentel: Intervention
After initial allocation the select patient received six educational interventions selected from Nursing Intervention Classification (NIC)
|
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Glycemic control - HbA1< 7%
Tidsramme: 1 year
|
blood sample after NIC interventions
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Improve Knowledge assessed by questionaries DKNA
Tidsramme: 1 year
|
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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Improve attitude and coping of Diabetes assessed by questionaries ATT-19
Tidsramme: 1 year
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Claudia Capellari, Master, Pontificia Universidade Católica do Rio Grande do Sul
- Ledende efterforsker: Ana Figueiredo, PhD, Pontificia Universidade Católica do Rio Grande do Sul
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2016
Primær færdiggørelse (Faktiske)
1. maj 2018
Studieafslutning (Forventet)
1. august 2018
Datoer for studieregistrering
Først indsendt
30. april 2018
Først indsendt, der opfyldte QC-kriterier
14. juni 2018
Først opslået (Faktiske)
15. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EnfDiaTrial
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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