Effects of Nursing Diabetes Self-management Education

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 1; Health Behavior
• Intervention / Treatment: Behavioral: Therapeutic education

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rocío Romero Castillo, Nursing; Phone Number: 34 675570012; Email: rocio.romero@cruzroja.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
Experimental: 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge in diabetes management	Measure by pre-test and post-test	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Data obtained by the continuous glucose monitoring sensor	3 months
Healthy diet and physical exercise	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	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

Collaborators and Investigators

• Sponsor: Hospitales Universitarios Virgen del Rocío

Study record dates

Study Major Dates

• Study Start (Anticipated): January 10, 2022
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Health Education; Self-management; Nurses
• 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: Tesis-ETD-2021

Plan for Individual participant data (IPD)

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

IPD Plan Description

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)

Drug and device information, study documents

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