NCT05766215

Brief Summary

The goal of this interventional quasiexperimental study is to learn about the influence of therapeutic education carried out by nurses in the management and knowledge of patients with T1DM. Participants will be: Given several therapeutic education sessions. Evaluated using different questionnaires and anthropometric measures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

December 22, 2022

Last Update Submit

September 26, 2023

Conditions

Nurse's Role

Keywords

type 1 diabetes mellitushealth educationglycated hemoglobin Ahealth-related knowledge

Outcome Measures

Primary Outcomes (9)

  • Glycated hemoglobin.

    HbA1c

    12 months

  • Time in Range

    TIR

    12 months

  • Time above range

    TAR

    12 months

  • Time below range

    TBR

    12 months

  • Coefficient of variation

    CV

    12 months

  • Glucose Management Indicator

    GMI

    12 months

  • Weight

    Kg

    12 months

  • Height

    cm

    12 months

  • Body Mass Index

    BMI

    12 months

Secondary Outcomes (4)

  • Perception of quality of life.

    12 months

  • Perception of symptoms of hypoglycemia

    12 months

  • Eating behavior,

    12 months

  • Adherence to diabetes treatment

    12 months

Other Outcomes (2)

  • Treatment type

    12 months

  • Demographical information

    12 months

Study Arms (1)

Therapeutic patients education

EXPERIMENTAL

3 sessions of structured therapeutic patient education (TPE) in which diet, exercise, alcohol abuse and insulin or pharmacological treatment management advise is given.

Behavioral: Therapeutic Education

Interventions

Therapeutic EducationBEHAVIORAL

It consists of four structured phases: 1. Welcome nurse visit, 2. Diabetologic education course adapted to the detected needs, 3. Individualized follow-up through alternating quarterly appointments between nurses and endocrine physician, 4. Evaluation and discharge of the program

Therapeutic patients education

Eligibility Criteria

Age17 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 17 years.

You may not qualify if:

  • Unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospitales Universitarios Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Health Education

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Enfermera de Práctica Avanzada (EPA)

Study Record Dates

First Submitted

December 22, 2022

First Posted

March 13, 2023

Study Start

September 30, 2023

Primary Completion

January 22, 2024

Study Completion

December 22, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)