Effects of Nursing Diabetes Self-management Education

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05159843
• Other study ID #: Tesis-ETD-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2021
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: Rocío Romero Castillo, Nursing
• Phone: 675570012
• Email: rocio.romero[@]cruzroja.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: September 1, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Health Behavior

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge in diabetes management	Measure by pre-test and post-test	3 months
Secondary	Glycemic control	Data obtained by the continuous glucose monitoring sensor	3 months
Secondary	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
Secondary	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