Control of Hypertension and diAbetes in MINas Gerais

NCT ID: NCT05660928

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2025-07-31

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.

Detailed Description

This scale up implementation study has mixed-methods, and comprehends four steps: (1) needs assessment, (2) baseline period, (3) cluster RCT and (4) qualitative study. The RE-AIM planning and evaluation framework will be used in this research project, which includes: reach (R), efficacy (E), adoption (A), implementation (I), and maintenance (M). The Adaptation Framework might be used as well, in case adaptations need to be conducted during the intervention, taking into account the COVID-19 pandemic and possible new waves.

1. A standardized structured questionnaire will be developed with open questions about the physical and technological structure, human resources and challenges managing patients with hypertension and DM, in order to carry out a brief situational diagnosis.

2. A baseline period of three months will be established to assess the basal condition of patients. Individuals will be assessed for blood pressure and glycohemoglobin measurements; functional performance (2-minute step test); anthropometric measurements (weight, height, and waist circumference); physical inactivity; alcohol consumption; smoking; and food consumption markers.

3. A two-arm parallel cluster RCT will be conducted, with a baseline period of three months and a subsequent follow-up period of 12 months from the start of the intervention. To avoid possible contamination within the same primary care unit, randomization will take place at a primary care centre level: each centre will be randomized to the control or the intervention arm, rather than individual patients. Randomization will be performed by computer software and stratified by geographic location and municipality, to ensure balance between arms.

4. At the end of the cluster-randomized controlled trial, another qualitative study will be carried out using the FG technique, in order to assess barriers and suggestions for improvement of each component of the implemented multidimensional strategy.

To calculate the sample size, the investigators took into account the proportion of patients with controlled hypertension (33%) and DM (37%) observed at baseline in the pilot study (data not published), and an absolute increase of 6% in these proportions one year after the implementation of the intervention, with a power of 0.80, level of significance of 0.05 and intra cluster correlation coefficient of 0.026. The calculated sample was 34 primary care centres, 17 in each arm, with a minimum of 148 participants in each centre. As the total number of primary care centres in the five municipalities is 35, the investigators planned to include one extra unit in the intervention arm. Taking into account a drop out rate of up to 17.8%, the total number of included individuals will be 180.

Conditions

Arterial Hypertension; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Multidimensional intervention

Intervention Type: OTHER

Multidimensional intervention, with mutidisciplinary approach.

Usual care

Seventeen primary care centers will be randomized to usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multidimensional intervention

Multidimensional intervention, with mutidisciplinary approach.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of the Valleys of Jequitinhonha and Mucuri

OTHER

Sponsor Role: collaborator

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Antonio Luiz Pinho Ribeiro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 37044364 (View on PubMed)

Other Identifiers

55598822.0.0000.5149

Identifier Type: -

Identifier Source: org_study_id