NCT05660928Completed
Control of Hypertension and diAbetes in MINas Gerais
Control of Hypertension and diAbetes in MINas Gerais: Assessment of the Impact of Implementing a Multidimensional Strategy for Management of Patients With Systemic Arterial Hypertension and Diabetes Mellitus in Primary Care
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5862 (actual)
- First submitted
- 16 Nov 2022
- Start date
- 21 Dec 2022
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Federal University of Minas Gerais
- Diseases
- High blood pressure
- NCT number
- NCT05660928
What you commit to
- Study type: Interventional
- Participants enrolled: 5862
- From 21 Dec 2022 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with terminal illness, with a life expectancy lower than 12 months according to the physician's evaluation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal University of Minas Gerais Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.