Optimizing Care for Diabetic Patients in Hospitalized Rehabilitation Through Structured Education

NCT06916871 | Not Yet Recruiting DMC

• 1 other identifier: 2024-416
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A large number of patients at the Neurological and Functional Rehabilitation Centre of the University Hospital of Liège have associated pathologies, including diabetes. These patients may have diabetes-related complications that require recurrent hospitalizations in an acute structure or in rehabilitation. One of the ways to limit complications is to set up patient education.

• To compare the impact of management through formal education with that of awareness.
• To evaluate the impact on knowledge of structured education.
• To evaluate the impact of structured education on the quality of life experienced by diabetic patients.
• Identify the patient's level of satisfaction with the education sessions.
• To evaluate the impact of structured education on the biological improvement of glycated hemoglobin.
• To evaluate the impact of structured education on diabetes-related complications.
• Working Hypothesis The implementation of structured diabetes education allows "patients to acquire, or maintain, the skills they need to manage their lives as well as possible despite the constraints of chronic disease... ".
• Study population All diabetic patients hospitalized in all care units.
• Collection tools and techniques Collection tools
• Validation of inclusion and exclusion criteria.
• Submission and distribution of the information and consent form.
• Obtaining informed consent from the patient.
• Distribution of collection tools 1 and 2 (collection on D+2).
• Control of glycated hemoglobin. At the end of hospitalization (D-2)
• Distribution of collection tools 1, 2 and 3 on D-2 before the release (collection on D-1).
• Control of glycated hemoglobin. 3 months after the end of hospitalization
• Sending collection tools 1, 2 and 4 by post. The patient will be invited to complete them and return them by post.
• The patient will be invited to take a blood test for glycated hemoglobin.

Conditions

Diabetes Mellitus Self Management Education

Keywords

optimisation; autonomie; diabète; réadaptation; éducation

Outcome Measures

Primary Outcomes (2)

• Diabete Knowledge Questionnaire.

  The DKQ consists of 15 multiple-choice questions relating to the minimum knowledge about diabetes. Fourteen of the fifteen questions concern type 1 and type 2 diabetes. Question 15 relates only to type 1 diabetes. Demographic data, such as age, gender, duration of diabetes, as well as type of drug treatment, are collected by an additional 16th question consisting of nine items. A score of 0 to 1 is assigned to each of the answers to the questions; For some questions, several answers must be checked. A score of 0 is assigned for an incorrect answer, 1 for a correct answer, and 0.5 for "unsure". For participants with type 2 diabetes who are not taking medication, the total possible score is a maximum of 26. It is 28 for people who take anti-diabetic medications. For participants with type 1 diabetes, the maximum possible score is 32.

  From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.

• Quality of life felt.

  The SF-36 short-form questionnaire is used to obtain a generic measure of perceptual health status. Each question is scored with a Lickert with a minimum value of 0 and a maximum value of 100. The lowest values indicate a poorer perceived quality of life and the higher values indicate a better quality of life.

  From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.

Secondary Outcomes (3)

• Patient's level of satisfaction.

  Two days before the end of hospitalization.

• Improvement of glycated hemoglobin.

  From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.

• Diabetes-related complications.

  3 months after the end of hospitalization.

Study Arms (2)

Awareness

ACTIVE COMPARATOR

The control group will benefit from awareness. Doctors and nursing staff will transmit information in a linear manner, i.e. explain, possibly argue and answer the patient's questions on topics such as interpreting blood sugar levels, explaining treatment, good practices in terms of diet, physical activity, etc. at the patient's bedside in an unstructured manner based on interactions between patient and caregivers. There is therefore no standard frequency, number of specific sessions, or topics addressed systematically.

Other: The control group will benefit from awareness

Education

EXPERIMENTAL

The experimental group will benefit from structured education which will be carried out by the diabetes nurse at a rate of 3 sessions for patients on oral anti-diabetics and 5 sessions for patients on insulin.

Other: The experimental group will benefit from structured education which will be carried out by the diabetes nurse

Interventions

The control group will benefit from awareness OTHER

During hospitalization in rehabilitation, doctors and nursing staff will transmit information in a linear manner, i.e. explain, possibly argue and answer the patient's questions on topics such as interpreting blood sugar levels, explaining treatment, good practices in terms of diet, physical activity, etc. at the patient's bedside in an unstructured manner based on interactions between patient and caregivers. There is therefore no standard frequency, number of specific sessions, or topics addressed systematically.

Awareness

The experimental group will benefit from structured education which will be carried out by the diabetes nurse OTHER

During hospitalization in rehabilitation, the experimental group will benefit from structured education which will be carried out by the diabetes nurse at a rate of 3 sessions for patients on oral anti-diabetics and 5 sessions for patients on insulin.

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having given written consent.
• Diagnosis of diabetes notified in medical file.
• Be at least 18 years old.
• Be able to communicate orally and in writing.
• Have a sufficient understanding of the French language.

You may not qualify if:

• Presence of cognitive disorder, confusion, spatio-temporal disorientation noted in the nursing and/or medical file.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead

Study Sites (1)

Centre Hospitalier Universitaire de Liège, site Centre Neurologique et de Réadaptation Fonctionnelle

Tinlot, Liège, 4557, Belgium

Location

Study Officials

• Théodora Giagoultsis, Head nurse

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

• Justine Slomian, scientist

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

• Nadia Jaajouai

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Héléna Cassol, PhD

CONTACT

+32 475 47 41 28; hcassol@chuliege.be

Théodora Giagoultsis, Head nurse

CONTACT

+32 4 323 27 18; t.giagoultsis@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: April 8, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)