Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Effects of Nursing Diabetes Self-management Education

3 december 2021 bijgewerkt door: Rocío Romero Castillo, Hospitales Universitarios Virgen del Rocío

Effects of Nursing Diabetes Self-management Education on Glycemic Control and Self-care

A study protocol for analyze the influence of therapeutic education on the metabolic control of patients with type I diabetes. To measure the change in glucose levels, it will use the continuous glucose monitoring sensor that the patients have implanted. It will perform a data download prior and after to the educational intervention. An assessment of acquired knowledge will also be performed and it will be analyzed whether learning about their disease and self-care helps to improve their emotional state.

The intervention of this study is only training with therapeutic education, it does not require any type of extra test or medical or pharmacological product. It will only be necessary to answer attitudinal questionnaires by the patient

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

A two-group randomized controlled trial will be used in this project. Participants in the experimental group will undergo four-session health education program, while the participants in the control group will receive the existing standard care provided by the hospital. Measurements will be conducted at the baseline prior to the intervention and at 1 an 3 months from the intervention.

To achieve a well balance in the randomization procedure block randomization of size 10 (with five experimental and five control) in seal envelops will be used. It will use the computerized randomization programme to generate the randomization programme to generate the randomization list using with block size of 10. A team member who will not be involved in recruitment and data collection will prepare the sealed envelopes according to the generated randomization list. After a patient is registered, a unique patient ID will be assigned to the patient based on the sequence of his/her enrolment. The envelope according to the patient's ID will be opened on site and the patient will be allocated into either one of the two groups based on the randomization list the treatment indicated.

Participants in control group receive usual services offered in University Hospital and other local health systems for patients with diabetes, which include regular visits with a diabetes provider (primary care or endocrine) and standard Spanish Diabetes Society information pamphlets. Consultation care is centralized in the pharmacological treatment regimen, dosage and guidelines.

Participants randomized to this arm receive therapeutic education during four sessions of four consecutive days. An advanced practice nurse who specializes in diabetes will teach these sessions. The sessions will have small groups of five patients and it will last of one hour each day. The outline of the session is as follow (Figure 1):

First session: Insulin administration and blood glucose self-analysis Second session: Management of hypoglycemia and hyperglycemia Third session: Healthy diet adapted to the diabetic patient Four session: Physical exercise

Studietype

Ingrijpend

Inschrijving (Verwacht)

176

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Have a confirmed diagnosis of type 1 diabetes
  • 18 years old and above
  • Able to speak, read and listen Spanish

Exclusion Criteria:

  • Have suffered from severe complications such as severe stroke, visual impairment or renal failure that interfere from severe complications such as severe stroke, visual impairment or renal failure that interfere with self-care activities
  • Have a history of major psychiatric conditions (for example schizophrenia), other than depression or anxiety
  • Have reading and hearing diffuculties
  • Be in police custody

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Diabetes Self-Management education

Participants randomized to this arm receive therapeutic education during four sessions of four consecutive days. An advanced practice nurse who specializes in diabetes will teach these sessions. The sessions will have small groups of five patients and it will last of one hour each day. The outline of the session is as follow (Figure 1):

First session: Insulin administration and blood glucose self-analysis Second session: Management of hypoglycemia and hyperglycemia Third session: Healthy diet adapted to the diabetic patient Four session: Physical exercise
Gedragsmatig: Therapeutic education

Participants randomized to this arm receive therapeutic education during four sessions of four consecutive days. An advanced practice nurse who specializes in diabetes will teach these sessions. The sessions will have small groups of five patients and it will last of one hour each day. The outline of the session is as follow (Figure 1):

First session: Insulin administration and blood glucose self-analysis Second session: Management of hypoglycemia and hyperglycemia Third session: Healthy diet adapted to the diabetic patient Four session: Physical exercise
Experimenteel: Usual care
Participants in control group receive usual services offered in University Hospital and other local health systems for patients with diabetes, which include regular visits with a diabetes provider (primary care or endocrine) and standard Spanish Diabetes Society information pamphlets. Consultation care is centralized in the pharmacological treatment regimen, dosage and guidelines.
Gedragsmatig: Therapeutic education

Participants randomized to this arm receive therapeutic education during four sessions of four consecutive days. An advanced practice nurse who specializes in diabetes will teach these sessions. The sessions will have small groups of five patients and it will last of one hour each day. The outline of the session is as follow (Figure 1):

First session: Insulin administration and blood glucose self-analysis Second session: Management of hypoglycemia and hyperglycemia Third session: Healthy diet adapted to the diabetic patient Four session: Physical exercise

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Knowledge in diabetes management
Tijdsspanne: 3 months
Measure by pre-test and post-test
3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glycemic control
Tijdsspanne: 3 months
Data obtained by the continuous glucose monitoring sensor
3 months
Healthy diet and physical exercise
Tijdsspanne: 3 months
Diabetes Self-Care Activities measure. The minimum value of this scale is 0 and the maximum is 49 points. Higher scores indicate better diabetes self-care outcomes.
3 months
Mood of patient
Tijdsspanne: 3 months
Measure by Goldberg Anxiety and Depression Scale. The minimum value of this scale is 0 and the maximum is 18 points. Higher values indicate higher levels of anxiety and depression, and therefore worse health outcomes
3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospitales Universitarios Virgen del Rocío

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

10 januari 2022

Primaire voltooiing (Verwacht)

31 mei 2022

Studie voltooiing (Verwacht)

1 september 2022

Studieregistratiedata

Eerst ingediend

22 november 2021

Eerst ingediend dat voldeed aan de QC-criteria

3 december 2021

Eerst geplaatst (Werkelijk)

16 december 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 december 2021

Laatste update ingediend die voldeed aan QC-criteria

3 december 2021

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Tesis-ETD-2021

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

According to the ethics committee and to respect data protection, clinical data will not be uploaded.

If others researchers wants more information, they will contact the IP (Rocío Romero Castillo)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes mellitus, type 1

Klinische onderzoeken op Therapeutic education

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Rwanda

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren