--- title: Impact of Telehealth Education in Diabetes Patients nct_id: NCT05696015 overall_status: UNKNOWN phase: NA sponsor: Hospital Israelita Albert Einstein study_type: INTERVENTIONAL primary_condition: Diabetes Mellitus, Type 1 canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05696015.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05696015" ct_last_update_post_date: 2023-01-30 last_seen_at: "2026-05-12T07:34:38.038Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Impact of Telehealth Education in Diabetes Patients **Official Title:** Impact of Telehealth Education After Hospital Discharge on the Self-care of Patients With Diabetes **NCT ID:** [NCT05696015](https://clinicaltrials.gov/study/NCT05696015) ## Key Facts - **Status:** UNKNOWN - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 200 - **Lead Sponsor:** Hospital Israelita Albert Einstein - **Conditions:** Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 - **Start Date:** 2023-03-02 - **Completion Date:** 2025-12-30 - **CT.gov Last Update:** 2023-01-30 ## 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Standard education** (ACTIVE_COMPARATOR) — 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. - **Amplied education** (EXPERIMENTAL) — 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. ## Interventions - **Standard education** (BEHAVIORAL) — Without telehealth education, this group has only postdischarge education. - **Ampiled Education** (BEHAVIORAL) — With telehealth education, in addition of discharge education. ## Primary Outcomes - **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)** _(time frame: immediately pre and within 4 weeks post intervention)_ — The QAD instrument has six dimensions and 15 items for evaluating self-care with diabetes: "general diet" (two items), "specific diet" (three items), "physical activity" (two items) , "blood glucose monitoring" (two items), "foot care" (three items) and "medication use" (three items, used according to the medication regimen), in addition to three other items for the assessment of smoking . Patients answer how often (answers from 0 to 7) they performed the activities or behaviors in the seven days prior to completing the form. For the calculation of scores, the items of the specific food dimension that ask about the consumption of foods high in fat and sweets, the values must be inverted (7=0, 6=1, 5=2, 4=3, 3=4 , 2=5, 1=6 and 0=7). Scores are calculated by averaging the items that make up each dimension, with zero being the least desirable situation and seven being the most favorable. - **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** _(time frame: 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)_ — 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. Contacts will be made via video call by trained health professionals, who will provide care based on a script structured by the authors, assessing adherence to self-care. The American Association of Diabetes Educators ( 7 Self-Care Behaviors ™) ) is a structured evidence-based tool that allows, in addition to self-care assessment, educational intervention in the seven topics covered, which include: 1) healthy eating, 2) physical activity, 3) glycemic monitoring , 4) medication use, 5) problem solving, 6) healthy coping, and 7) risk reduction. ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05696015.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05696015* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*