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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nurse's Role
• Intervention / Treatment: Behavioral: Therapeutic Education

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:

1. Age (years), sex (female/male), T1DM evolution (years).
2. Treatment type (basal-bolus/insulin pump). Sensor usage time (>80%)
3. 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 ).
4. Perception of quality of life. Test SF-12, of 12 questions.
5. Perception of symptoms of hypoglycemia. Clarke test, 8 questions.
6. Eating behavior, with the EPAD-R test, of 16 questions.
7. 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.

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Hospitales Universitarios Virgen del Rocío

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 17 years.

Exclusion Criteria:

• Unable to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic patients education; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of quality of life.	SF-12	12 months
Perception of symptoms of hypoglycemia	Clarke	12 months
Eating behavior,	EPAD-R	12 months
Adherence to diabetes treatment	SCI-R	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment type	basal-bonus, insulin pump, sensor usage range	12 months
Demographical information	Age (years), sex (female/male), T1DM evolution (years).	12 months

Collaborators and Investigators

• Sponsor: Hospitales Universitarios Virgen del Rocío

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): January 22, 2024
• Study Completion (Estimated): December 22, 2024

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: type 1 diabetes mellitus; health education; glycated hemoglobin A; health-related knowledge
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: MPSA-ETDT-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No