Control of Hypertension and diAbetes in MINas Gerais

NCT05660928 | Completed DMC

• 1 other identifier: 55598822.0.0000.5149
• Study Type: interventional
• Target: 5,862
• Locations: 1 country
• Sites: 1

Brief 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

Arterial Hypertension; Diabetes Mellitus

Keywords

Hypertension; Diabetes mellitus; Telemedicine; Primary health care

Outcome Measures

Primary Outcomes (1)

• Composite outcome of proportion of patients with controlled disease

  (i) for hypertension, the proportion (%) of patients with systolic blood pressure (SBP) \<140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg; (ii) for diabetes, the proportion (%) of patients with glycohemoglobin ≤ 7% if the age \< 60 years, or \< 8% if the age is ≥ 60 years; (iii) for those with both hypertension and diabetes, proportion (%) of patients with both diseases controlled.

  12 months

Secondary Outcomes (6)

• Proportion of patients with controlled hypertension

  12 months

• Proportion of patients with controlled diabetes

  12 months

• Change in blood pressure

  12 months

• Change in glycohemoglobin

  12 months

• Number of blood pressure measurements

  12 months

Other Outcomes (9)

• Percentage of patients who participated in group activities in 12 months.

  12 months

• Total follow-up time of patients

  12 months

• Number of consultations during the follow-up time

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Eighteen primary care centers will be randomized to the intervention arm, which consists of a multidimensional strategy, with a multidisciplinary approach, for the management of patients with hypertension and diabetes in the primary care setting. It is going to include: 1. Telehealth tools: clinical decision support system for primary care professionals to support the care of patients with hypertension and diabetes; clinical decision support system to support community health agents (ACS), for use in home visits; asynchronous teleconsultations; telediagnosis for digital electrocardiogram and retinography reports; text messages to patients, to provide information, education, improve adherence to treatment and encourage patients to promote health; 2. Continued education for health professionals; 3. Strengthening the educational groups and promotion of lifestyle changes, with a focus on promoting healthy eating and reducing sedentary behavior.

Other: Multidimensional intervention

Usual care

NO INTERVENTION

Seventeen primary care centers will be randomized to usual care.

Interventions

Multidimensional intervention OTHER

Multidimensional intervention, with mutidisciplinary approach.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with terminal illness, with a life expectancy lower than 12 months according to the physician's evaluation.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Federal University of the Valleys of Jequitinhonha and Mucuri: collaborator
• Medical Research Council: collaborator
• University of Southampton: collaborator

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (1)

• Fonseca SF, Ribeiro ALP, Cimini CCR, Soares TBC, Delfino-Pereira P, Nogueira LT, Moura RMF, Motta-Santos D, Ribeiro LB, Camargos MCS, Paixao MC, Pires MC, Batchelor J, Marcolino MS. Scale up of implementation of a multidimensional intervention to enhance hypertension and diabetes care at the primary care setting: A protocol for a cluster-randomized study in Brazil. Am Heart J. 2023 Aug;262:119-130. doi: 10.1016/j.ahj.2023.04.006. Epub 2023 Apr 11.

  PMID: 37044364 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomized controlled trial.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 21, 2022
• Study Start: December 21, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

BR (1)