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Enrolling By Invitation
NCT05660928
Control of Hypertension and diAbetes in MINas Gerais
Conditions: Arterial Hypertension, Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 5132
Sponsor: Federal University of Minas Gerais
Location: Brazil
Summary
Hypertension and diabetes mellitus (DM) are highly prevalent in low and middle-income countries, and the proportion of patients with uncontrolled diseases is higher than in high income countries.
Innovative strategies are required to surpass barriers of low sources, distance, and quality of healthcare.
Our aim is to assess the uptake and effectiveness of the implementation of an integrated multidimensional strategy in the primary care setting, for the management of patients with hypertension and diabetes mellitus (DM) in Brazil.
This is a scale up implementation study that has mixed-methods, and comprehends four steps: (1) needs assessment, including a standardized structured questionnaire and focus groups with healthcare practitioners; (2) baseline period, three months before the implementation of the intervention; (3) cluster randomized controlled trial (RCT) with a 12-month follow-up period; and (4) a qualitative study after the end of follow-up.
The cluster RCT will randomize 35 centres to intervention (n= 18) or usual care (n= 17).
Patients ≥18 years-old, with diagnosis of hypertension and/or DM, of five Brazilian cities in a resource-constrained area will be enrolled.
The intervention consists of a multifaceted strategy, with a multidisciplinary approach, including telehealth tools (decision support systems, short message service, telediagnosis), continued education with an approach to issues related to the care of people with hypertension and diabetes in primary care, including pharmacological and non-pharmacological treatment and behavioural change.
The project has actions focused on professionals and patients.
Eligibility Criteria
Inclusion Criteria:Primary Health Care - Basic health unit with internet availability and complete team, including a Brazilian doctor or with a proficiency test in the Portuguese language.Patients- Adult patients (from 18 years-old), diagnosed with hypertension and/or DM, registered in the medical record.Subproject cluster randomised controlled trial.
All of the above criteria and the following additional criteria:Patients aged ≥ 18 years-old, with a diagnosis of hypertension and diabetes mellitus, registered in the medical record;Absence of contraindications to physical activity, according to the assistant physician's assessment;In intervention levels II and III, it will be a prerequisite that the participant has a smartphone.Exclusion Criteria:Patients with terminal illness, with a life expectancy lower than 12 months according to the physician's evaluation.
Source: ClinicalTrials.gov (NCT05660928). StuddyBuddy aggregates publicly available trial information.
