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NCT05696015 | Not yet recruiting | Diabetes Mellitus, Type 1


Impact of Telehealth Education in Diabetes Patients
Sponsor:

Hospital Israelita Albert Einstein

Information provided by (Responsible Party):

Simone Brandi

Brief Summary:

The goal of this clinical trial is to to evaluate the effectiveness of continuity of in-hospital care with the application of a structured telemonitoring protocol in self-care activities in patients with type 1 or type 2 Diabetes Mellitus or those who have an HbA1C level greater than or equal to 6.5% during hospitalization, regardless of the reason for hospitalization. The main question[s] it aims to answer are: • Is telehealth education effective for improving self-care for type 1 or type 2 Diabetes Mellitus or those with an HbA1C level greater than or equal to 6.5% during hospitalization will be included, regardless of the reason for hospitalization? Participants will answer the Diabetes Self-Care Activity Questionnaire Researchers will compare patients in the intervention group, in addition to the hospital's standard hospital guidance, will receive an educational approach through structured telemonitoring, reinforcing and validating the points addressed in the face-to-face guidance, which are considered the foundations of self-care.

Condition or disease

Diabetes Mellitus, Type 1

Diabetes Mellitus, Type 2

Intervention/treatment

Standard education

Ampiled Education

Phase

Not Applicable

Detailed Description:

This study have two groups of patients. Group 1 will be carried out at discharge, discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD). For this group, a new contact will be made within 30 days after discharge, where the QAD will be applied again. Group 2 will be performed at the time of discharge, guidance for discharge of patients with diabetes. This group will receive 3 contacts, the first will be carried out within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge, where diabetes education guidelines will be given to the patient in all contacts. At the time of discharge, and in the third contact, 30 days, the QAD will also be applied.}}

Study Type : Interventional
Estimated Enrollment : 200 participants
Masking : None (Open Label)
Masking Description : Patients will be randomized using the Randomizer software into a group that will receive the telemonitoring intervention and a control group (which will only receive the hospital's standard hospital discharge instructions).
Primary Purpose : Other
Official Title : Impact of Telehealth Education After Hospital Discharge on the Self-care of Patients With Diabetes
Actual Study Start Date : March 2, 2023
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2025
Arm Intervention/treatment

Active Comparator: Standard education

Standard education group will be carried out at discharge, discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD). For this group, a new contact will be made within 30 days after discharge, where the QAD will be applied again.

Behavioral: Standard education

Experimental: Amplied education

Amplied education group will be performed at the time of discharge, guidance for discharge of patients with diabetes. This group will receive 3 contacts, the first will be carried out within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge, where diabetes education guidelines will be given to the patient in all contacts. At the time of discharge, and in the third contact, 30 days, the QAD will also be applied.

Behavioral: Ampiled Education

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • patients who were hospitalized at Hospital Israelita Albert Einstein and included in the subcutaneous insulin protocol to control hyperglycemia
  • patients monitored by the Diabetes Program, an institutional program that manages glycemic changes that occur within the institution.
  • patients with type 1 or type 2 Diabetes Mellitus or those with an HbA1C level greater than or equal to 6.5% during hospitalization.
Exclusion Criteria
  • Patients not submitted to the first face-to-face educational approach required by protocol
  • Patients discharged on the weekend or holidays

Impact of Telehealth Education in Diabetes Patients

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Impact of Telehealth Education in Diabetes Patients

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