Diabetes Mellitus
Conditions
Interventions
Randomized, multicenter clinical trial of a control group conducted by three independent arms to assess the effectiveness of telemonitoring for patients discharged from hospital admitted for Diabetes
exacerbated Chronic Obstructive Pulmonary Disease (COPD) and Heart Failure (HF) in Belo Horizonte, Minas Gerais, Brazil. Data collection (T0) will take place in six hospitals (Metropolitano Odilon Beh
Santa Casa de Misericórdia de Belo Horizonte
Risoleta Tolentino Neves Hospital
Metropolitano Dr. Célio de Castro Hospital
Clinical Hospital of UFMG
Júlia Kubitschek Hospital of the FHEMIG network) at the hospital just before the patients discharge, during which the patients eligibility for the three arms will be checked. Participants will receive
clinical and laboratory data will be obtained from the participants' medical records
measurements of Blood Pressure, Oxygen Saturation, Heart Rate, Respiratory Rate, weight, height and waist circumference also will be obtained, quality of life data will be collected through the Diabet
Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Short-Form Health Survey (SF12) for the CI arm
St. George’s Respiratory Questionnaires (SGRQ), COPD Assessment Test ™ (CAT) and mMRC dyspnea scale (modified Medical Research Council) for the COPD arm. For participants in the COPD arm, three tests
the 1-minute sit-to-stand test and the single-leg stance tes
Sponsors
Faculdade de Medicina da Universidade Federal de Minas Gerais
Instituto de Saúde da Comunidade da Univerisdade Federal Fluminense
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients willing and able to complete the study requirements, including signing the Informed Consent Form. Patients discharged due to Congestive heart failure, Chronic obstructive pulmonary disease and diabetes mellitus requesting insulin. Patients residing in Belo Horizonte, Minas Gerais. Adult patients over 18 years old.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding patients. Patients with Chronic Kidney Disease on dialysis. Cancer patients undergoing chemotherapy. Patients with diseases that reduce survival to less than six months. Patients undergoing bariatric surgery. Patients using depot corticotherapy daily use or expected use for more than fourteen days in the next six months. Patients undergoing enteral nutritional therapy. Patients unable to interview or to operate telemonitoring devices. Complete illiterate patients. Patients with severe motor and cognitive neurological sequelae. Patients with recent blood loss, severe anemia, hereditary anemia or use of blood transfusion. Patients in whom the diagnosis of exacerbated COPD has not been confirmed, having been replaced by other differential diagnoses such as left ventricular failure, pulmonary thromboembolism. Patients with clinical indication for oxygen home therapy without access to oxygen. Patients with acute myocardial infarction less than 72 hours, unstable angina less than 72 hours after stabilization. Patients with symptomatic severe valvular heart disease with surgical indication. Patients with uncontrolled arterial hypertension: SBP greater than 190mmHg and DBP greater than 120mmHg. Patients with decompensated heart failure, severe complex ventricular arrhythmias, suspected instability or severe left coronary artery injury, infective endocarditis, myocarditis or pericarditis, type A aortic dissection or acute type B phase and severe symptomatic obstruction of the ventricular outflow tract left with low effort-induced output. Patients with orthopedic or neurological conditions that overlap the respiratory condition and that limit physical activity. Patients who have acute causes of heart failure in the past 30 days, such as acute coronary syndrome, cardiac surgery or invasive procedures, implantation of devices. Patients with invasive cardiac procedures scheduled for the three months following the enrollment of participants. Patients in line for heart transplantation or with an implanted ventricular assist device. Patients with a condition that may limit compliance with study procedures such as known alcohol and drug abuse. Patients participating in other intervention studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a 1.0% reduction in Glycated Hemoglobin monitored for 6 months, verified through laboratory tests done one week after enrollment and six months after the intervention.;Assess mortality from all causes, number of readmissions due to exacerbation and the time in days for readmission due to exacerbation verified through the municipality's information record during the 3-month follow-up period.;Assess unplanned mortality and hospitalization for all causes verified through the municipality's information record during the 6-month follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess number of days of hospitalization; number of emergency visits for COPD verified through the municipality's information record during the 3-month follow-up period.;Evaluate health-related quality of life verified using the Short-Form Health Survey (SF12), Minnesota Living with Heart Failure Questionnaire (MLHFQ) and St. George’s Respiratory Questionnaires (SGRQ) applied pre and post-intervention.;Assess the physical and functional capacity through the tests the test timed up and go; the 1 minute sit to stand test, and the single leg stance test applied pre and post-intervention. | — |
Countries
Brazil
Contacts
Public ContactTúlio Franco
Outcome results
None listed