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Nurse-led Therapeutic Education Effects in Glycemic Control and Knowledge of Type 1 Diabetes Mellitus Patients Under Hospital Transition

Primary Purpose

Nurse's Role

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic Education
Sponsored by
Hospitales Universitarios Virgen del Rocío
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nurse's Role focused on measuring type 1 diabetes mellitus, health education, glycated hemoglobin A, health-related knowledge

Eligibility Criteria

17 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 17 years. Exclusion Criteria: Unable to give informed consent.

Sites / Locations

  • Hospitales Universitarios Virgen del Rocío

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic patients education

Arm Description

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

Outcomes

Primary Outcome Measures

Glycated hemoglobin.
HbA1c
Time in Range
TIR
Time above range
TAR
Time below range
TBR
Coefficient of variation
CV
Glucose Management Indicator
GMI
Weight
Kg
Height
cm
Body Mass Index
BMI

Secondary Outcome Measures

Perception of quality of life.
SF-12
Perception of symptoms of hypoglycemia
Clarke
Eating behavior,
EPAD-R
Adherence to diabetes treatment
SCI-R

Full Information

First Posted
December 22, 2022
Last Updated
September 26, 2023
Sponsor
Hospitales Universitarios Virgen del Rocío
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1. Study Identification

Unique Protocol Identification Number
NCT05766215
Brief Title
Nurse-led Therapeutic Education Effects in Glycemic Control and Knowledge of Type 1 Diabetes Mellitus Patients Under Hospital Transition
Official Title
Influence of Nurse-led Therapeutic Patient Education on Glycemic Control and Knowledge of Patients With Type 1 Diabetes Mellitus in Hospital Transition: a Quasi-experimental Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
January 22, 2024 (Anticipated)
Study Completion Date
December 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospitales Universitarios Virgen del Rocío

4. Oversight

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

5. Study Description

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.
Detailed Description
The main objective of the study will be to determine the influence of therapeutic education carried out by nurses in the management and knowledge of patients with T1DM who will make a hospital transition. The research design will be a single-blind, nonrandomized, quasi-experimental, single-center, 1-group controlled study . It will be developed at the Center for Diagnosis and Treatment (CDT) of the Virgen del Rocío University Hospital (HUVR), in Seville (Spain). The participant selection process will be carried out considering that only 13 adolescents 17 and 18 years and younger with T1DM, belonging to the reference hospital area, will transit from the Children's Hospital to the Adult Hospital. It is estimated that the study will have a sample of a minimum of n=10, which will be studied over 12 months. Given the existing bibliography about the benefits of this intervention , 1 it is expected that the glycosylated hemoglobin (HbA1c) of patients will be less than 7%, which together with the Self-Management Adherence Questionnaire for Diabetes Treatment (SCI-R. es) 2 represents that patients perform adequate management of their disease. The Survey of Eating Problems in Diabetes Summary Questionnaire (EPAD-R) 3 will be used to assess their eating behavior. An improvement in people's knowledge regarding hypoglycemia is also sought, measured with the Clarke test 4 ; and an improvement in the quality of life, measured with the SF-12 questionnaire 5 and family support with the Apgar test 6 . The therapeutic plan consists of preparing the process prior to discharge from the pediatric center, transferring to the adult hospital with a clinical and educational report and a previously arranged visit to the new unit. The heads of both teams coordinate the structure and the transition process with regular meetings. From the Adult Diabetes Day Hospital, a joint visit is reserved with the endocrinologist and the nurse educator. They are integrated into a 12-month therapeutic care and education program. 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. At the beginning (baseline visit), at 3 and 12 months the following variables are recorded: Age (years), sex (female/male), T1DM evolution (years). Treatment type (basal-bolus/insulin pump). Sensor usage time (>80%) Metabolic control: HbA1C (mg/ dL ), Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), Coefficient of Variation (CV), Mean Glucose (GMI), weight (Kg), height (cm), BMI (Kg/m 2 ). Perception of quality of life. Test SF-12, of 12 questions. Perception of symptoms of hypoglycemia. Clarke test, 8 questions. Eating behavior, with the EPAD-R test, of 16 questions. Adherence to diabetes treatment. SCI-R.es test. The results analysis plan will be carried out using Microsoft Excel, SPSS or R Commander computer programs , in which the relationships between the descriptive statistics extracted from the screened data will be explored to prevent duplicates. The same digital tools will be used to guarantee the protection of the data and variables collected. This aspect is detailed in the attached informed consent. Regarding the ethical and legal aspects of the study, it is worth mentioning the benefit in disease management, quality of life and general satisfaction that the protocolized follow-up will cause in adolescents. No risk to the psychosocial integrity of the population involved in the study has been detected. The necessary facilities will be the Education Classroom of the HUVR Diabetes Day Hospital, computer support through 2 computers, paper resources for the questionnaires, 2 nurses and 1 endocrinologist will be necessary as human resources. The authors declare the absence of funding or conflict of interest for the development of the research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nurse's Role
Keywords
type 1 diabetes mellitus, health education, glycated hemoglobin A, health-related knowledge

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic patients education
Arm Type
Experimental
Arm Description
3 sessions of structured therapeutic patient education (TPE) in which diet, exercise, alcohol abuse and insulin or pharmacological treatment management advise is given.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Education
Intervention Description
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
Primary Outcome Measure Information:
Title
Glycated hemoglobin.
Description
HbA1c
Time Frame
12 months
Title
Time in Range
Description
TIR
Time Frame
12 months
Title
Time above range
Description
TAR
Time Frame
12 months
Title
Time below range
Description
TBR
Time Frame
12 months
Title
Coefficient of variation
Description
CV
Time Frame
12 months
Title
Glucose Management Indicator
Description
GMI
Time Frame
12 months
Title
Weight
Description
Kg
Time Frame
12 months
Title
Height
Description
cm
Time Frame
12 months
Title
Body Mass Index
Description
BMI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Perception of quality of life.
Description
SF-12
Time Frame
12 months
Title
Perception of symptoms of hypoglycemia
Description
Clarke
Time Frame
12 months
Title
Eating behavior,
Description
EPAD-R
Time Frame
12 months
Title
Adherence to diabetes treatment
Description
SCI-R
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Treatment type
Description
basal-bonus, insulin pump, sensor usage range
Time Frame
12 months
Title
Demographical information
Description
Age (years), sex (female/male), T1DM evolution (years).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 17 years. Exclusion Criteria: Unable to give informed consent.
Facility Information:
Facility Name
Hospitales Universitarios Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Nurse-led Therapeutic Education Effects in Glycemic Control and Knowledge of Type 1 Diabetes Mellitus Patients Under Hospital Transition

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