Arterial HypertensionCHArMINGNCT05660928
Control of Hypertension and diAbetes in MINas Gerais
A study testing Multidimensional intervention in people with Arterial Hypertension and Diabetes Mellitus, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension, Diabetes Mellitus
- What is being tested?
- Multidimensional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,862 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Dec 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with terminal illness, with a life expectancy lower than 12 months according to the physician's evaluation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
About this study
Official title: 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
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.
Read the 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.
- 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.
- 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.
- 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.
- 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
- Being tested
- Multidimensional intervention
- Keywords
- Hypertension, Diabetes mellitus, Telemedicine, Primary health care
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional interventionOther
Multidimensional intervention, with mutidisciplinary approach.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multidimensional intervention |
| Usual care | No intervention | Seventeen primary care centers will be randomized to usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Proportion of patients with controlled hypertension
The proportion (%) of patients with systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) < 90 mmHg
Measured: 12 months
Proportion of patients with controlled diabetes
The proportion (%) of patients with glycohemoglobin ≤ 7% if the age < 60 years, or < 8% if the age is ≥ 60 years
Measured: 12 months
Change in blood pressure
The mean difference in delta SBP and DBP (mmHg) in patients with hypertension, when comparing the intervention and the control groups, in 12 months
Measured: 12 months
Change in glycohemoglobin
The mean difference in delta glycohemoglobin (%) in patients with diabetes, when comparing the intervention and the control groups, in 12 months
Measured: 12 months
Number of blood pressure measurements
Number of blood pressure measurements per patient with hypertension in 12 months
Measured: 12 months
Number of glycohemoglobin measurements
Number of glycohemoglobin measurements per patient with diabetes in 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start21 Dec 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 5,862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of the Valleys of Jequitinhonha and Mucuri, Medical Research Council, University of Southampton
- Responsible party
- Principal investigator, Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660928
- Sponsor's protocol ID
- 55598822.0.0000.5149
- Acronym
- CHArMING
- Status last verified
- Sep 2025
- First submitted
- 16 Nov 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37044364
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05660928
- Acronym / sponsor ID
- CHArMING / 55598822.0.0000.5149
- Conditions
- Arterial Hypertension, Diabetes Mellitus
- Keywords
- Hypertension, Diabetes mellitus, Telemedicine, Primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,862 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Federal University of the Valleys of Jequitinhonha and Mucuri, Medical Research Council, University of Southampton
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Multidimensional interventionEighteen 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. |
| Usual care | No intervention | –Seventeen primary care centers will be randomized to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- Patients with terminal illness, with a life expectancy lower than 12 months according to the physician's evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional interventionMultidimensional intervention, with mutidisciplinary approach. | Other | Intervention |
Primary outcome
Composite outcome of proportion of patients with controlled disease
Time frame: 12 months
(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.
6 secondary outcomes
Proportion of patients with controlled hypertension
Time frame: 12 months
Proportion of patients with controlled diabetes
Time frame: 12 months
Change in blood pressure
Time frame: 12 months
Change in glycohemoglobin
Time frame: 12 months
Number of blood pressure measurements
Time frame: 12 months
Number of glycohemoglobin measurements
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 37044364Fonseca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional intervention in people with Arterial Hypertension and Diabetes Mellitus, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of proportion of patients with controlled disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05660928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.