Effects of Nursing Diabetes Self-management Education

Sponsor

Hospitales Universitarios Virgen del Rocío (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05159843

Collaborator

(none)

176

Enrollment

Arms

7.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1 Health Behavior	Behavioral: Therapeutic education	N/A

Detailed Description

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model 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.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.

Masking:

Double (Participant, Care Provider)

Masking Description:

Primary Purpose:

Supportive Care

Official Title:

Effects of Nursing Diabetes Self-management Education on Glycemic Control and Self-care

Anticipated Study Start Date :

Jan 10, 2022

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Experimental: Usual care

Behavioral: Therapeutic education

Outcome Measures

Primary Outcome Measures

Knowledge in diabetes management [3 months]
Measure by pre-test and post-test

Secondary Outcome Measures

Glycemic control [3 months]
Data obtained by the continuous glucose monitoring sensor
Healthy diet and physical exercise [3 months]
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.
Mood of patient [3 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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