Clinical trial NCT05159843: Effects of Nursing Diabetes Self-management Education
Official title: Effects of Nursing Diabetes Self-management Education on Glycemic Control and Self-care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Health Behavior
Keywords: Type 1 Diabetes
Health Education
Nurses
Self-management
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge in diabetes management
timeFrame: 3 months
Secondary outcomes:
measure: Glycemic control
timeFrame: 3 months
measure: Healthy diet and physical exercise
timeFrame: 3 months
measure: Mood of patient
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: