Clinical trial NCT05696015: Impact of Telehealth Education in Diabetes Patients
Official title: Impact of Telehealth Education After Hospital Discharge on the Self-care of Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: self care
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomized clinical trial.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD) at 30 days follow-up. (Standard education)
timeFrame: immediately pre and within 4 weeks post intervention
measure: Change from baseline discharge telehealth orientation and application of the Diabetes Self-Care Activity Questionnaire (QAD) at within 72 hours after discharge, 10 days after and within 30 days after discharge
timeFrame: immediately pre and within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Whitehouse CR, Long JA, Maloney LM, Daniels K, Horowitz DA, Bowles KH. Feasibility of Diabetes Self-Management Telehealth Education for Older Adults During Transitions in Care. Res Gerontol Nurs. 2020 May 1;13(3):138-145. doi: 10.3928/19404921-20191210-03. Epub 2019 Dec 13.
citation: Ose D, Kamradt M, Kiel M, Freund T, Besier W, Mayer M, Krisam J, Wensing M, Salize HJ, Szecsenyi J. Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial. PLoS One. 2019 Jun 12;14(6):e0214056. doi: 10.1371/journal.pone.0214056. eCollection 2019.
citation: So CF, Chung JW. Telehealth for diabetes self-management in primary healthcare: A systematic review and meta-analysis. J Telemed Telecare. 2018 Jun;24(5):356-364. doi: 10.1177/1357633X17700552. Epub 2017 May 2.