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Control of Hypertension and diAbetes in MINas Gerais

NCT05660928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5862

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Multidimensional intervention

Multidimensional intervention, with mutidisciplinary approach.

Sponsors & Collaborators

  • Federal University of the Valleys of Jequitinhonha and Mucuri

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • University of Southampton

    collaborator OTHER

  • Federal University of Minas Gerais

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660928 on ClinicalTrials.gov